Submission Builder Impact Assessment

Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
Submission Builder
Impact Assessment
Medical Devices, IVDs & Combination Devices
May – July 2026
Assessment date: July 29, 2026 · Data cut-off: July 29, 2026
Scope & Methodology This report assesses 164 regulatory alerts across 60+ markets to determine their specific impact on Submission Builder wizards. Each alert receives two separate evaluations: regulated-party impact (what manufacturers must do) and SB impact (what wizards must change). Pharma-only alerts (44 total) are listed in the Annex. Priority follows the SB priority model: P0 Release blocker → P1 Confirmed update → P2 Scheduled review → Watchlist → No SB action.
RegDesk Submission Builder · Confidential Page 1 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Executive Summary

Alert Counts · Priority Distribution · Top Actions
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded

Alert Overview

164
Alerts In Scope
3
P0 Release Blockers
94
P1 Confirmed Updates
49
P2 Scheduled Reviews
15
Watchlist
3
No SB Action
44
Excluded (Pharma/OOS)
208
Total Reviewed

Top 5 Highest-Priority SB Actions

Alert IDMarketAlertPriorityAction
SB-2026-073 Spain Launch of RECOPS, the New Application for the Marketing Registration o P0 Implement
SB-2026-081 United States Content of Human Factors Information in Medical Device Marketing Submi P0 Implement
SB-2026-086 United States eSTAR Program P0 Implement
SB-2026-001 Malaysia Joint Announcement by Medical Device Authority (MDA) Malaysia and Thai P1 Monitor
SB-2026-002 Turkey Mandatory Use of the EUDAMED Database System (Law No. 2026/KKB-1) and P1 Compare

Markets with Most In-Scope Alerts

CountryCount
Australia13
Switzerland13
China13
Korea7
Mexico6
Kazakhstan6
Denmark5
Serbia5
United States4
Malaysia4
Nicaragua4
United Kingdom4
Czech Republic4
Brazil4
Turkey3

SB Priority Framework

PriorityDefinition
P0Active wizard is materially incorrect, unusable or cannot generate an acceptable submission
P1Final requirement affects a released wizard; implement promptly
P2Relevant clarification or lower-risk content change; schedule review
WatchlistDraft, consultation or unverified revision; no implementation yet
No SB actionOperational, post-market, admin or business-compliance alert outside wizard scope

Impact Taxonomy

Category
No SB impact
Instructions/reference update
Existing wizard content update
Conditional logic or pathway update
Official form/source-template update
Export/XML/data-mapping update
New wizard or coverage-gap assessment
Manual technical review
Watchlist—draft or unverified
RegDesk Submission Builder · Confidential Page 2 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

SB Action Dashboard

All In-Scope Alerts · Prioritized · 164 Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
Alert ID Market Published Alert (abbreviated) Priority Impact Category Action Confidence
SB-2026-073 Spain 5/27/2026 Launch of RECOPS, the New Application for the Marketing P0 Conditional logic or pathway u Implement High
SB-2026-081 United States 5/28/2026 Content of Human Factors Information in Medical Device P0 Existing wizard content update Implement High
SB-2026-086 United States 6/1/2026 eSTAR Program P0 Existing wizard content update Implement High
SB-2026-001 Malaysia 5/1/2026 Joint Announcement by Medical Device Authority (MDA) Ma P1 Conditional logic or pathway u Monitor Medium
SB-2026-002 Turkey 5/4/2026 Mandatory Use of the EUDAMED Database System (Law No. 2 P1 Instructions/reference update Compare Medium
SB-2026-007 Australia 5/4/2026 Accessing and using the AusUDID P1 Existing wizard content update Compare High
SB-2026-008 Australia 5/4/2026 AusUDID submission methods P1 Existing wizard content update Compare High
SB-2026-009 Australia 5/4/2026 Accessing the AusUDID P1 Instructions/reference update Compare Medium
SB-2026-010 Australia 5/4/2026 AusUDID data elements P1 Existing wizard content update Compare High
SB-2026-011 Saudi Arabia 5/5/2026 Guidance on Bundling Criteria for Medical Devices withi P1 Existing wizard content update Compare High
SB-2026-014 Spain 5/4/2026 The AEMPS Updates the Information on the Medical Device P1 Instructions/reference update Compare Medium
SB-2026-016 European Union 5/5/2026 Implementing Regulation (EU) 2026/977 – Uniform Require P1 Existing wizard content update Compare High
SB-2026-017 Denmark 5/5/2026 Medical Devices with Incorporated Drug P1 Conditional logic or pathway u Compare High
SB-2026-020 Saudi Arabia 5/5/2026 SFDA Medical Devices Forms Updates P1 Official form/source-template Implement High
SB-2026-021 Turkey 5/7/2026 TCOKKA - Publication of Implementing Regulation (EU) 20 P1 Existing wizard content update Compare High
SB-2026-022 Australia 5/11/2026 Using assessments from comparable overseas regulators f P1 Conditional logic or pathway u Compare High
SB-2026-023 Australia 5/11/2026 Use of market authorisation evidence from comparable ov P1 Conditional logic or pathway u Compare High
SB-2026-024 Switzerland 5/10/2026 Swissdamed User Manual Actors P1 Existing wizard content update Implement High
SB-2026-026 Algeria 5/11/2026 Note No. 42 to Pharmaceutical Establishment Relating to P1 Existing wizard content update Compare Low
SB-2026-028 Egypt 5/14/2026 Regulatory Guideline on Requirements for Unique Device P1 Existing wizard content update Compare High
SB-2026-030 Nicaragua 5/13/2026 New Importation/Exportation Form P1 Official form/source-template Implement High
SB-2026-033 United Kingdom 5/13/2026 Medical Devices: Conformity Assessment and the UKCA Mar P1 Existing wizard content update Compare High
SB-2026-035 Bahrain 5/13/2026 Launch of TATABU Medical Devices & Supplies Traceabilit P1 New wizard or coverage-gap ass Monitor Medium
SB-2026-037 Malaysia 5/15/2026 Requirements for Labelling of Medical Devices P1 Existing wizard content update Compare High
SB-2026-038 Malaysia 5/15/2026 Change Management for Registered Medical Devices P1 Existing wizard content update Compare High
SB-2026-039 Ecuador 5/18/2026 ARCSA has published Resolution ARCSA-DE-2026-003-DASP - P1 Existing wizard content update Compare Medium
SB-2026-041 Nicaragua 5/15/2026 User Guide for Requesting the Issuance of a Registratio P1 Instructions/reference update Compare Medium
SB-2026-042 Nicaragua 5/15/2026 New Official Request Form for Health Registration Certi P1 Official form/source-template Implement High
SB-2026-043 Vietnam 5/15/2026 Notice on Domain Change for the Online Public Service P P1 Instructions/reference update Implement High
SB-2026-046 United Kingdom 5/14/2026 Clinical Investigations for Medical Devices P1 Existing wizard content update Compare High
SB-2026-047 Serbia 5/15/2026 New Conditions and Methods of Recognition of Foreign Do P1 Conditional logic or pathway u Compare High
SB-2026-048 Serbia 5/15/2026 New Conditions and Methods of Recognition of Foreign Ce P1 Conditional logic or pathway u Compare High
SB-2026-049 Serbia 5/15/2026 New Conditions and Methods of Recognition of Foreign Do P1 Conditional logic or pathway u Compare High
SB-2026-050 Serbia 5/15/2026 New Conditions and Methods of Recognition of Foreign Ce P1 Conditional logic or pathway u Compare High
SB-2026-051 Serbia 5/15/2026 Instructions for Submitting a Request for Amendment/Add P1 Existing wizard content update Compare High
SB-2026-052 Czech Republic 5/18/2026 Application for Authorization to place a Medical Device P1 Existing wizard content update Compare High
SB-2026-053 Mexico 5/19/2026 Cofepris has published Mexican Official Standard NOM-13 P1 Existing wizard content update Implement High
SB-2026-060 Peru 5/21/2026 DIGEMID has published Ministerial Resolution No. 193-20 P1 Existing wizard content update Compare Low
SB-2026-062 Australia 5/22/2026 Complying with the Unique Device Identification timefra P1 Instructions/reference update Compare Medium
SB-2026-065 Czech Republic 5/18/2026 Methodological Instructions for Submitting an Applicati P1 Existing wizard content update Compare High
SB-2026-066 Sweden 5/25/2026 Regulations (HSLF-FS 2026:11) amending the Medical Prod P1 Existing wizard content update Compare High
SB-2026-067 Portugal 5/20/2026 Operationalization of EUDAMED on May 28, 2026 P1 Instructions/reference update Compare High
SB-2026-074 Denmark 5/27/2026 Distributor and Specialist Store Registration P1 Existing wizard content update Compare Medium
SB-2026-076 Denmark 5/28/2026 Registration in Eudamed P1 Instructions/reference update Compare Medium
SB-2026-077 Czech Republic 5/27/2026 Temporary Retention of FSC Applications through RZPRO P1 Instructions/reference update Compare Medium
SB-2026-082 Belgium 5/28/2026 EUDAMED: Clarifications Regarding Obligations as of 28 P1 Existing wizard content update Compare High
SB-2026-083 Slovenia 5/13/2026 Q&A Education May 13, 2026: Obligations of Distributors P1 Existing wizard content update Compare Medium
SB-2026-084 Brazil 6/1/2026 Guidance: Importation via DUIMP_v1.9 P1 Instructions/reference update Compare High
SB-2026-087 Czech Republic 6/1/2026 Methodological Guideline for the Implementation of MDR P1 Existing wizard content update Compare High
SB-2026-089 Oman 6/3/2026 Requirements for Approval of Optical Companies Applying P1 Existing wizard content update Compare Medium
SB-2026-091 Switzerland 6/2/2026 Swissdamed Business Rules P1 Existing wizard content update Compare High
SB-2026-092 Uzbekistan 5/27/2026 New legislative changes will come into force in Uzbekis P1 Existing wizard content update Compare Medium
SB-2026-094 Singapore 6/2/2026 GN-12-1: Guidance on Grouping of Medical Devices for Pr P1 Conditional logic or pathway u Compare High
SB-2026-095 South Africa 6/4/2026 Regulatory Requirements for Medical Devices Electronic P1 Existing wizard content update Compare High
SB-2026-097 Germany 5/28/2026 European Database for Medical Devices: EUDAMED P1 Instructions/reference update Compare Medium
SB-2026-098 Germany 5/28/2026 May 28, 2026: Initial and Amendment Notification MP and P1 Existing wizard content update Compare Medium
SB-2026-100 Srilanka 5/21/2026 Reissuance of Sample Import License (SIL)-Medical Devic P1 Existing wizard content update Compare Medium
SB-2026-101 Srilanka 5/21/2026 Checklist for Document Accepting of Consolidated new Me P1 Official form/source-template Implement High
SB-2026-102 Algeria 5/13/2026 Guidelines for Regulatory Trust (Reliance) and Recognit P1 Conditional logic or pathway u Compare Medium
SB-2026-105 Lebanon 6/9/2026 Circular No. 23 Regarding FDA-Approved Implantable Medi P1 Existing wizard content update Compare High
SB-2026-107 Germany 6/9/2026 Self-declaration Regarding the Implementation of the Re P1 Existing wizard content update Compare Medium
SB-2026-108 Latvia 5/28/2026 EUDAMED, The European Database for Medical Devices, Lau P1 Instructions/reference update Compare Low
SB-2026-109 Luxembourg 5/28/2026 Mandatory use of EUDAMED from May 28, 2026 P1 Instructions/reference update Compare Low
SB-2026-112 China 6/1/2026 China NMPA Issues Announcement on Medical Device Classi P1 Conditional logic or pathway u Compare High
SB-2026-115 Hungary 6/10/2026 Deviation from Conformity Assessment Procedures P1 Existing wizard content update Compare Medium
SB-2026-116 Hungary 6/10/2026 Conformity Assessment Bodies P1 Existing wizard content update Compare Medium
SB-2026-117 United Kingdom 6/11/2026 Regulation of Medical Devices in Northern Ireland P1 Existing wizard content update Compare High
SB-2026-118 Korea 6/10/2026 Labeling Guideline for Digital Medical Devices P1 Existing wizard content update Compare High
SB-2026-120 Hong Kong 6/12/2026 GN-02: Guidance Notes for Listing Class II/III/IV Gener P1 Existing wizard content update Compare High
SB-2026-121 Hong Kong 6/12/2026 GN-06: Guidance Notes for Listing Class B/C/D In Vitro P1 Existing wizard content update Compare High
SB-2026-122 Brazil 6/12/2026 ANVISA Expands Support and Improvement Measures to Supp P1 Instructions/reference update Compare High
SB-2026-123 Kyrgyzstan 6/8/2026 On Amendments to the Resolution of the Cabinet of Minis P1 Existing wizard content update Compare Medium
SB-2026-125 Mexico 6/17/2026 Cofepris has published an update to the Guide to Requir P1 Existing wizard content update Compare High
SB-2026-127 Canada 6/17/2026 Phase 2 of our Work to Modernize Medical Device Establi P1 Existing wizard content update Compare High
SB-2026-129 Belarus 6/16/2026 Transfer of Medical Device Regulatory Functions in Bela P1 Existing wizard content update Implement High
SB-2026-130 Switzerland 6/18/2026 Swissdamed User Manual Actors P1 Existing wizard content update Implement High
SB-2026-131 Rwanda 6/18/2026 Regulations Governing Good Manufacturing Practices of M P1 Existing wizard content update Compare Medium
SB-2026-132 Botswana 6/18/2026 BOMRA Medical Devices, including IVDs, Regulatory Updat P1 New wizard or coverage-gap ass Monitor Medium
SB-2026-133 Switzerland 6/19/2026 New Options for Product Registration in Swissdamed: Onl P1 Instructions/reference update Compare Medium
SB-2026-137 Switzerland 6/19/2026 User Manual Swissdamed UDI Device Module P1 Existing wizard content update Compare High
SB-2026-140 European Union 6/18/2026 MDCG Position Paper: Management of SS(C)P in EUDAMED af P1 Instructions/reference update Compare Medium
SB-2026-142 Mexico 6/22/2026 Update on the Reliance Regulatory Fast Track Platform P1 Conditional logic or pathway u Compare Medium
SB-2026-143 Korea 6/23/2026 Enforcement Decree of the Medical Device Act P1 Existing wizard content update Compare High
SB-2026-146 Australia 6/24/2026 Complying with the Unique Device Identification timefra P1 Instructions/reference update Compare Medium
SB-2026-147 Australia 6/24/2026 Unique Device Identification Consent to Supply process P1 Conditional logic or pathway u Compare High
SB-2026-151 Kazakhstan 6/24/2026 Law of Kazakhstan On Amendments and Supplements to Cer P1 Existing wizard content update Compare High
SB-2026-152 South Africa 6/25/2026 Communication on Research Use Only (RUO) and Investigat P1 Official form/source-template Implement High
SB-2026-154 China 6/23/2026 China's NMPA Issues 2026 Revised Registration Review Gu P1 Existing wizard content update Compare High
SB-2026-155 China 6/18/2026 China's NMPA Releases Technical Review Guidelines for V P1 Existing wizard content update Compare Medium
SB-2026-156 China 6/15/2026 China's NMPA Issues Trial Technical Review Guidelines f P1 Existing wizard content update Compare Medium
SB-2026-157 India 6/24/2026 Sale of In-Vitro Fertilization Media, Reagents, and Rel P1 Existing wizard content update Compare Medium
SB-2026-158 Korea 6/23/2026 Enforcement Decree of the Medical Device Act P1 Existing wizard content update Compare High
SB-2026-160 Brazil 6/25/2026 TECHNICAL NOTE Nº 41/2026/SEI/GQUIP/GGTPS/DIRE3/ANVISA P1 Existing wizard content update Compare Medium
SB-2026-161 Korea 6/26/2026 Approval and Review Guideline for Digital Medical Devic P1 Conditional logic or pathway u Compare High
SB-2026-162 Kyrgyzstan 6/18/2026 On Amendments to the Resolution of the Government of th P1 Existing wizard content update Compare Medium
SB-2026-163 Oman 6/28/2026 Extension of Registration Period for High-Risk Medical P1 Instructions/reference update Compare Medium
SB-2026-164 Malaysia 6/1/2026 Malaysia MDA: Fully Online Product Classification Appli P1 Conditional logic or pathway u Implement High
SB-2026-003 Mexico 5/4/2026 Cofepris has published the “Agreement establishing meas P2 Manual technical review Escalate Low
SB-2026-004 Mexico 5/4/2026 Cofepris has published the “Agreement Updating the Meth P2 Manual technical review Escalate Low
SB-2026-005 Iraq 5/6/2026 Circular to Scientific Offices and Companies P2 Instructions/reference update Compare Low
SB-2026-012 Chile 5/7/2026 Exempt Resolution No. 2.050/2026 approves the “Guidelin P2 Manual technical review Escalate Low
SB-2026-013 Chile 5/6/2026 ISP Announces New Certification Program for Domestic an P2 New wizard or coverage-gap ass Monitor Medium
SB-2026-015 United States 5/6/2026 Patient-Matched Guides for Orthopedic Implants P2 Existing wizard content update Compare Medium
SB-2026-018 Switzerland 5/1/2026 Manufacturer Incident Report Guideline P2 Existing wizard content update Compare Medium
SB-2026-019 Switzerland 5/1/2026 Information Sheet Combined Studies P2 Instructions/reference update Compare Low
SB-2026-025 Algeria 5/10/2026 Note No. 41 to Pharmaceutical Establishment and Economi P2 Instructions/reference update Compare Low
SB-2026-027 Hong Kong 5/13/2026 GN-00: Definitions and Abbreviations for the Medical De P2 Instructions/reference update Compare Low
SB-2026-029 Turkey 5/13/2026 Guidelines for Registration Processes of Medical Device P2 Manual technical review Escalate Low
SB-2026-031 Paraguay 5/13/2026 DINAVISA has published Resolution No. 189/2026 P2 Existing wizard content update Compare Low
SB-2026-032 United Kingdom 5/11/2026 MHRA invites Views on Proposed Changes to Medical Devic P2 Watchlist—draft or unverified Monitor Medium
SB-2026-034 Finland 5/11/2026 Medical Device Manufacturers must report Serious Incide P2 Manual technical review Escalate Low
SB-2026-036 Australia 5/12/2026 Preparing for an application audit for in-vitro diagnos P2 Instructions/reference update Compare Medium
SB-2026-040 Peru 5/15/2026 DIGEMID - Announcement No. 006/2026 P2 Instructions/reference update Compare Low
SB-2026-044 China 5/8/2026 China NMPA Issues Guidance on Registration Review for P P2 Existing wizard content update Compare Medium
SB-2026-045 Ireland 5/13/2026 Guide to Pre-submission Scientific and Regulatory Advic P2 Instructions/reference update Compare Low
SB-2026-059 Mexico 5/21/2026 Guidelines for promoting National Investment in the pro P2 Manual technical review Escalate Low
SB-2026-061 Kazakhstan 5/19/2026 Order of the Minister of Health of the Republic of Kaza P2 Manual technical review Escalate Low
SB-2026-063 Australia 5/12/2026 Preparing for an application audit for in-vitro diagnos P2 Instructions/reference update Compare Medium
SB-2026-068 Korea 5/26/2026 Approval and Review Procedures for New Technology Medic P2 Existing wizard content update Compare Medium
SB-2026-069 Switzerland 5/26/2026 Template Trend Report P2 Official form/source-template Compare Medium
SB-2026-070 Switzerland 5/26/2026 Template PSR Report P2 Official form/source-template Compare Medium
SB-2026-071 South Africa 5/26/2026 Guideline on How to Respond to a GMP, GWP, GCP or GVP I P2 Instructions/reference update Compare Medium
SB-2026-072 Korea 5/28/2026 FAQs for Medical Device Non-clinical Trials Guidance P2 Instructions/reference update Compare Medium
SB-2026-075 Denmark 5/28/2026 Registration P2 Manual technical review Escalate Low
SB-2026-078 Cameroon 5/29/2026 Implementation of a combined Individual Case Safety Rep P2 Manual technical review Escalate Low
SB-2026-079 Iraq 5/31/2026 Announcement from the Pharmacy Department, Private Sect P2 Instructions/reference update Monitor Low
SB-2026-080 Singapore 5/28/2026 How Medical Devices are Regulated by HSA and their Safe P2 Instructions/reference update Monitor Low
SB-2026-085 Argentina 6/1/2026 Update on fees for ANMAT procedures P2 Manual technical review Escalate Low
SB-2026-088 Syria 6/3/2026 Regulatory Decision 8/T P2 Watchlist—draft or unverified Escalate Low
SB-2026-090 Iraq 6/3/2026 Circular No. 9/2/1163 To All Scientific Offices and Nat P2 Instructions/reference update Monitor Low
SB-2026-093 Uzbekistan 5/5/2026 On measures to provide additional support to the privat P2 Watchlist—draft or unverified Monitor Low
SB-2026-096 Uzbekistan 5/25/2026 Departmental regulatory legal act on the procedure for P2 Instructions/reference update Compare Low
SB-2026-099 United States 6/5/2026 Intent to Exempt Certain Unclassified Medical Devices f P2 Conditional logic or pathway u Monitor Medium
SB-2026-106 Switzerland 6/8/2026 Swissdamed Machine-to-Machine REST API Technical Docume P2 Export/XML/data-mapping update Monitor Medium
SB-2026-124 China 6/5/2026 China’s NMPA Announces Removal of 10 Medical Device Ind P2 Manual technical review Escalate Low
SB-2026-126 Peru 6/17/2026 Announcement No. 008/2026 - Webinar on the Medical Devi P2 Instructions/reference update Monitor Low
SB-2026-128 Saudi Arabia 6/18/2026 Standard Specification Annex No. (1) of the Technical R P2 Watchlist—draft or unverified Monitor Medium
SB-2026-134 Switzerland 6/19/2026 Amendment to the Swissmedic Fee Ordinance as of July 1, P2 Instructions/reference update Compare Medium
SB-2026-135 Switzerland 6/19/2026 Procurement of Medical Devices in Healthcare Facilities P2 Manual technical review Escalate Low
SB-2026-136 Switzerland 6/19/2026 Swissdamed User Guide - Playground P2 Instructions/reference update Monitor Low
SB-2026-138 Sweden 6/17/2026 The Swedish Medicines Agency will be responsible for AI P2 Watchlist—draft or unverified Monitor Medium
SB-2026-139 European Union 6/17/2026 Guidance on standardisation for medical devices P2 Instructions/reference update Monitor Medium
SB-2026-141 Bahrain 6/9/2026 Updated Fee Schedules of Services and Requests for Medi P2 Instructions/reference update Compare Low
SB-2026-144 Australia 6/22/2026 New UDI Newsletter P2 Instructions/reference update Monitor Low
SB-2026-145 Australia 6/22/2026 Getting started with UDI P2 Instructions/reference update Compare Low
SB-2026-159 Bolivia 6/25/2026 CIRCULAR-22-2026 P2 Manual technical review Escalate Low
SB-2026-006 China 5/6/2026 NMPA Seeks Public Comments on Three Medical Device Regi Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-054 Kazakhstan 5/19/2026 Resolution of the Government of the Republic of Kazakhs Watchlist Watchlist—draft or unverified Monitor Low
SB-2026-055 Kazakhstan 5/19/2026 On Amendments to the Order of the Minister of Health of Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-056 China 5/12/2026 China Seeks Public Comment on Draft Registration Review Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-057 China 5/11/2026 China Seeks Public Comment on Draft Registration Review Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-058 China 5/6/2026 China Releases Draft Guidance for Public Comment on Thr Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-064 Kazakhstan 5/22/2026 On amendments and additions to the joint order of the M Watchlist Watchlist—draft or unverified Monitor Low
SB-2026-103 Nicaragua 6/8/2026 Public Consultation 175 - (NTON) 24001 Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-110 China 6/3/2026 China NMPA Seeks Public Input on Four Draft Medical Dev Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-111 China 6/10/2026 China NMPA Opens Public Consultation on Draft Registrat Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-114 Kazakhstan 6/10/2026 On amendments to the order of the Minister of Health of Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-119 Korea 6/12/2026 Medical Device Manufacturing and Quality Control Standa Watchlist Watchlist—draft or unverified Monitor Medium
SB-2026-148 Brazil 6/23/2026 ANVISA Opens Public Call for Proposals to Improve Techn Watchlist Watchlist—draft or unverified Monitor Low
SB-2026-150 Kyrgyzstan 6/25/2026 Government's Decree Watchlist Watchlist—draft or unverified Monitor Low
SB-2026-153 China 6/17/2026 China's NMPA Invites Industry Participation in Drafting Watchlist Watchlist—draft or unverified Monitor Low
SB-2026-104 Lebanon 6/9/2026 Circular No. 22 Regarding the Entry of Import Invoices No SB action No SB impact Close High
SB-2026-113 Singapore 6/11/2026 Mean Applicant Screening Response Time Audiences No SB action No SB impact Close High
SB-2026-149 Denmark 6/18/2026 Fees for Clinical Trials of Medical Devices No SB action No SB impact Close High
RegDesk Submission Builder · Confidential Page 3 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 4

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-073 P0 Spain · 5/27/2026 · Notification Launch of RECOPS, the New Application for the Marketing Registration of Medical Devices
Regulated-party impactAEMPS launched RECOPS for marketing registration of MD and IVDs in Spain from May 27, 2026. Custom-made devices continue via RPS.
SB impactSpain MD/IVD marketing registration wizard must be updated for RECOPS portal fields, attachments, identifiers, and applicant information. Separate custom-made device pathway (RPS) must be maintained. This is a P0 release blocker — any Spain wizard is materially incorrect if it does not reference RECOPS.
Impact categoryConditional logic or pathway update + Existing wizard content update
Affected pathwayNew registration
Affected elementsRECOPS fields, Spain wizard submission channel, MD/IVD registration pathway, custom-made device RPS exception, applicant information, labeling/IFU attachments, device identifiers
Required actionImplement
Enforcement date6/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.aemps.gob.es/informa/puesta-en-marcha-de-recops-...
SB-2026-081 P0 United States · 5/28/2026 · Guidance Content of Human Factors Information in Medical Device Marketing Submissions
Regulated-party impactFDA guidance on Human Factors content in marketing submissions effective Aug 1, 2026. Manufacturers must include HF summaries in 510(k)/PMA/De Novo.
SB impacteSTAR wizard (IVD and nIVD) must incorporate new HF submission content requirements. This is the companion guidance to the eSTAR program update.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsHF summary section, formative/summative study fields, use error analysis, IFU/labeling usability questions
Required actionImplement
Enforcement date5/29/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.fda.gov/media/163694/download
SB-2026-086 P0 United States · 6/1/2026 · Guidance eSTAR Program
Regulated-party impactFDA updated eSTAR IVD and nIVD source files effective August 1, 2026, incorporating Human Factors guidance content.
SB impacteSTAR IVD and nIVD wizards must be updated: new HF question content, conditional logic, PDF/XML source file associations, and export parity testing required before Aug 1.
Impact categoryExisting wizard content update + Export/XML/data-mapping update
Affected pathwayNew registration
Affected elementsIVD eSTAR source file, nIVD eSTAR source file, HF question blocks, conditional logic, XML label mapping, PDF output, export testing
Required actionImplement
Enforcement date8/1/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.fda.gov/medical-devices/how-study-and-market-you...
SB-2026-001 P1 Malaysia · 5/1/2026 · Notification Joint Announcement by Medical Device Authority (MDA) Malaysia and Thai Food and Drug Admin
Regulated-party impactMalaysia MDA and Thailand FDA joint announcement on device regulatory cooperation.
SB impactMonitor for reliance pathway implications. If Malaysia accepts Thai FDA approvals via reliance, wizard pathway logic may need updating.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsReliance pathway, submission type selection
Required actionMonitor
Enforcement date5/1/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://portal.mda.gov.my/index.php/ms/pengumuman/1795-joint...
RegDesk Submission Builder · Confidential Page 4 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 5

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-002 P1 Turkey · 5/4/2026 · Announcement Mandatory Use of the EUDAMED Database System (Law No. 2026/KKB-1) and its Impact on the ÜT
Regulated-party impactEUDAMED-related notification.
SB impactReview wizard references to EUDAMED and ensure actor/UDI registration guidance is current.
Impact categoryInstructions/reference update
Affected pathwayUDI / New registration
Affected elementsEUDAMED references, actor registration
Required actionCompare
Enforcement date5/4/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.titck.gov.tr/duyuru/2026-kkb-1-sayili-eudamed-ve...
SB-2026-007 P1 Australia · 5/4/2026 · Guidance Accessing and using the AusUDID
Regulated-party impactTGA updated guidance on accessing and using the Australian UDI Database (AusUDID).
SB impactAustralia UDI wizard sections must reflect current AusUDID access and submission methods.
Impact categoryExisting wizard content update
Affected pathwayUDI
Affected elementsAusUDID access guidance, UDI submission fields
Required actionCompare
Enforcement dateN/A
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.tga.gov.au/products/medical-devices/labelling-an...
SB-2026-008 P1 Australia · 5/4/2026 · Guidance AusUDID submission methods
Regulated-party impactTGA published AusUDID submission methods guidance.
SB impactAustralia UDI wizard submission method options should reflect AusUDID submission methods.
Impact categoryExisting wizard content update
Affected pathwayUDI
Affected elementsUDI submission method selection, AusUDID fields
Required actionCompare
Enforcement dateN/A
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.tga.gov.au/products/medical-devices/labelling-an...
SB-2026-009 P1 Australia · 5/4/2026 · Guidance Accessing the AusUDID
Regulated-party impactTGA guidance on accessing AusUDID.
SB impactUpdate Australia UDI wizard help text and instructions.
Impact categoryInstructions/reference update
Affected pathwayUDI
Affected elementsUDI wizard instructions
Required actionCompare
Enforcement dateN/A
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.tga.gov.au/resources/resources/user-guide/access...
RegDesk Submission Builder · Confidential Page 5 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 6

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-010 P1 Australia · 5/4/2026 · Guidance AusUDID data elements
Regulated-party impactTGA published AusUDID data elements guidance.
SB impactAustralia UDI wizard data fields must align with AusUDID data elements.
Impact categoryExisting wizard content update
Affected pathwayUDI
Affected elementsUDI data fields, data element mapping
Required actionCompare
Enforcement dateN/A
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.tga.gov.au/products/medical-devices/labelling-an...
SB-2026-011 P1 Saudi Arabia · 5/5/2026 · Guidance Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application (MDS –
Regulated-party impactSFDA published bundling criteria for devices within a single MDMA application.
SB impactSaudi Arabia bundling/grouping wizard logic must reflect new SFDA bundling criteria.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsBundling criteria, grouping logic, MDMA application wizard
Required actionCompare
Enforcement date5/5/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://sfda.gov.sa/en/taxonomy/term/3
SB-2026-014 P1 Spain · 5/4/2026 · Notification The AEMPS Updates the Information on the Medical Device Surveillance System and the Functi
Regulated-party impactSpain AEMPS updated surveillance system information linked to RECOPS launch.
SB impactConfirm Spain post-market and registration wizard references are current with RECOPS launch.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsSubmission instructions, post-market references
Required actionCompare
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.aemps.gob.es/informa/la-aemps-actualiza-la-infor...
SB-2026-016 P1 European Union · 5/5/2026 · Guidance Implementing Regulation (EU) 2026/977 – Uniform Requirements for Conformity Assessment and
Regulated-party impactEU published uniform requirements for conformity assessment procedures (MDR/IVDR). Economic operators must comply.
SB impactVerify EU MDR/IVDR conformity assessment wizard sections align with 2026/977 requirements. Check QMS and technical file section references.
Impact categoryExisting wizard content update
Affected pathwayNew registration / Renewal
Affected elementsConformity assessment section, QMS evidence fields, notified body references, Annex references
Required actionCompare
Enforcement date5/4/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
RegDesk Submission Builder · Confidential Page 6 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 7

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-017 P1 Denmark · 5/5/2026 · Notification Medical Devices with Incorporated Drug
Regulated-party impactDenmark DKMA notification on combination products (medical devices with incorporated drug).
SB impactDenmark wizard combination product pathway should reflect current requirements for devices with incorporated drugs.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsCombination product pathway, drug-device wizard, Denmark
Required actionCompare
Enforcement date—
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://laegemiddelstyrelsen.dk/da/udstyr/bemyndigede-organe...
SB-2026-020 P1 Saudi Arabia · 5/5/2026 · Forms SFDA Medical Devices Forms Updates
Regulated-party impactSaudi Arabia SFDA updated medical device forms.
SB impactSaudi Arabia wizard source forms must be updated to reflect new SFDA form versions.
Impact categoryOfficial form/source-template update
Affected pathwayNew registration
Affected elementsApplication forms, form fields, Saudi Arabia wizard source templates
Required actionImplement
Enforcement date5/5/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://sfda.gov.sa/en/forms?keys=&date%5Bmin%5D=&date%5Bmax...
SB-2026-021 P1 Turkey · 5/7/2026 · Announcement TCOKKA - Publication of Implementing Regulation (EU) 2026/977 on Common Requirements for N
Regulated-party impactEU published uniform requirements for conformity assessment procedures (MDR/IVDR). Economic operators must comply.
SB impactVerify EU MDR/IVDR conformity assessment wizard sections align with 2026/977 requirements. Check QMS and technical file section references.
Impact categoryExisting wizard content update
Affected pathwayNew registration / Renewal
Affected elementsConformity assessment section, QMS evidence fields, notified body references, Annex references
Required actionCompare
Enforcement dateNot Announced
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.titck.gov.tr/duyuru/tcokka-avrupa-komisyonunca-o...
SB-2026-022 P1 Australia · 5/11/2026 · Guidance Using assessments from comparable overseas regulators for medical devices
Regulated-party impactTGA updated guidance on using comparable overseas regulator assessments for device registration.
SB impactAustralia reliance/abridged pathway wizard logic should reflect updated comparable overseas regulator guidance.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsReliance pathway wizard, comparable regulator list, supporting evidence fields
Required actionCompare
Enforcement dateN/A
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.tga.gov.au/resources/guidance/using-assessments-...
RegDesk Submission Builder · Confidential Page 7 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 8

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-023 P1 Australia · 5/11/2026 · Guidance Use of market authorisation evidence from comparable overseas regulators and assessment bo
Regulated-party impactTGA guidance on using overseas market authorization evidence.
SB impactAustralia reliance pathway wizard evidence requirements should be reviewed.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsReliance evidence fields, overseas authorization references
Required actionCompare
Enforcement dateN/A
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.tga.gov.au/resources/guidance/use-market-authori...
SB-2026-024 P1 Switzerland · 5/10/2026 · Guidance Swissdamed User Manual Actors
Regulated-party impactSwitzerland mandatory Swissdamed use from July 1, 2026. Actors must register in Swissdamed.
SB impactSwitzerland wizard must cover Swissdamed actor registration pathway. Separate assessments needed for: MD, IVD, SPP, legacy devices, transitional registrations, immediate registration exception (serious incidents/FSCA), per-UDI-DI fees.
Impact categoryExisting wizard content update
Affected pathwayNew registration / Actor registration
Affected elementsActor registration, SRN equivalent, MD registration pathway, IVD pathway, SPP pathway, legacy device pathway, transitional rules, immediate registration trigger, fee fields
Required actionImplement
Enforcement date5/10/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
SB-2026-026 P1 Algeria · 5/11/2026 · Notice Note No. 42 to Pharmaceutical Establishment Relating to Requests for Classification of Pro
Regulated-party impactAlgeria note on classification requests for economic operators.
SB impactAlgeria MD classification wizard may need update.
Impact categoryExisting wizard content update
Affected pathwayClassification
Affected elementsClassification wizard, Algeria
Required actionCompare
Enforcement date5/11/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://drive.google.com/file/d/18bQPUjjwVZSPdJOU3HPKIs8mp5O...
SB-2026-028 P1 Egypt · 5/14/2026 · Guideline Regulatory Guideline on Requirements for Unique Device Identification (UDI) for Medical De
Regulated-party impactEgypt published UDI regulatory guideline for medical devices.
SB impactEgypt UDI wizard section must be reviewed against new guideline requirements.
Impact categoryExisting wizard content update
Affected pathwayUDI
Affected elementsUDI data fields, GTIN, UDI-DI, UDI-PI, Egypt UDI wizard
Required actionCompare
Enforcement date5/14/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://edaegypt.gov.eg/media/g1cjdm3z/5-udi_up-2026.pdf
RegDesk Submission Builder · Confidential Page 8 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 9

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-030 P1 Nicaragua · 5/13/2026 · Regulation New Importation/Exportation Form
Regulated-party impactNicaragua updated importation/exportation form for medical devices.
SB impactNicaragua import authorization wizard source form must be updated.
Impact categoryOfficial form/source-template update
Affected pathwayImport authorization
Affected elementsImport form, form fields, Nicaragua wizard
Required actionImplement
Enforcement date5/13/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.minsa.gob.ni/sites/default/files/publicaciones/F...
SB-2026-033 P1 United Kingdom · 5/13/2026 · Guidance Medical Devices: Conformity Assessment and the UKCA Mark
Regulated-party impactMHRA updated conformity assessment and UKCA guidance.
SB impactUK MD/IVD wizard conformity assessment and UKCA sections should be reviewed.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsUKCA pathway, conformity assessment fields, NB references
Required actionCompare
Enforcement date5/13/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.gov.uk/guidance/medical-devices-conformity-asses...
SB-2026-035 P1 Bahrain · 5/13/2026 · Circular Launch of TATABU Medical Devices & Supplies Traceability System
Regulated-party impactBahrain NHRA launched TATABU traceability system for medical devices.
SB impactAssess whether Bahrain wizard covers TATABU registration/traceability requirements.
Impact categoryNew wizard or coverage-gap assessment
Affected pathwayNew registration
Affected elementsBahrain traceability system, device registration fields
Required actionMonitor
Enforcement date5/13/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.nhra.bh/MediaHandler/GenericHandler/documents/de...
SB-2026-037 P1 Malaysia · 5/15/2026 · Guidance Requirements for Labelling of Medical Devices
Regulated-party impactMalaysia MDA published updated labeling requirements for medical devices.
SB impactMalaysia MD registration wizard labeling section must be reviewed against new MDA requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsLabeling fields, IFU requirements, language requirements, MDA labeling checklist
Required actionCompare
Enforcement date5/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://portal.mda.gov.my/index.php/ms/pengumuman/1800-revis...
RegDesk Submission Builder · Confidential Page 9 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 10

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-038 P1 Malaysia · 5/15/2026 · Guidance Change Management for Registered Medical Devices
Regulated-party impactMalaysia MDA published change management guidance for registered devices.
SB impactMalaysia variation/change notification wizard must be reviewed against new change management guidance.
Impact categoryExisting wizard content update
Affected pathwayVariation
Affected elementsVariation wizard, change notification fields, change categories, supporting documents
Required actionCompare
Enforcement date5/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://portal.mda.gov.my/index.php/ms/pengumuman/1799-publi...
SB-2026-039 P1 Ecuador · 5/18/2026 · Resolution ARCSA has published Resolution ARCSA-DE-2026-003-DASP - Technical Health Regulations for O
Regulated-party impactEcuador ARCSA published technical health regulation for medical device storage, distribution, and transport (GDP/GMP).
SB impactEcuador wizard GMP/GDP evidence requirements should reflect new ARCSA resolution.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsGMP/GDP evidence, distribution requirements, technical file sections
Required actionCompare
Enforcement date1/28/2027
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://esacc.corteconstitucional.gob.ec/storage/api/v1/10_D...
SB-2026-041 P1 Nicaragua · 5/15/2026 · Guidance User Guide for Requesting the Issuance of a Registration Certificate and Related Procedure
Regulated-party impactNicaragua published updated user guide for registration certificate requests.
SB impactNicaragua wizard submission instructions should reference updated user guide.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsSubmission instructions, registration certificate fields
Required actionCompare
Enforcement date5/15/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.minsa.gob.ni/sites/default/files/publicaciones/M...
SB-2026-042 P1 Nicaragua · 5/15/2026 · Guidance New Official Request Form for Health Registration Certificates and Signature Validation of
Regulated-party impactNicaragua new official request form for health registration certificates.
SB impactNicaragua wizard source form for registration certificates must be updated.
Impact categoryOfficial form/source-template update
Affected pathwayNew registration
Affected elementsRegistration form, form fields
Required actionImplement
Enforcement date5/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.minsa.gob.ni/sites/default/files/publicaciones/F...
RegDesk Submission Builder · Confidential Page 10 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 11

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-043 P1 Vietnam · 5/15/2026 · Notification Notice on Domain Change for the Online Public Service Portal of Vietnam Infrastructure and
Regulated-party impactVietnam changed domain for online public service portal.
SB impactVietnam wizard submission channel URL/link must be updated.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsSubmission URL, portal link, Vietnam wizard
Required actionImplement
Enforcement date10/1/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://imda.moh.gov.vn/trangchu
SB-2026-046 P1 United Kingdom · 5/14/2026 · Guidance Clinical Investigations for Medical Devices
Regulated-party impactMHRA updated clinical investigation submission guidance including IRAS integration and supporting document requirements.
SB impactUK clinical investigation wizard must be updated to reflect IRAS requirements and new supporting document checklist.
Impact categoryExisting wizard content update
Affected pathwayClinical investigation
Affected elementsIRAS integration, supporting documents, clinical investigation application wizard
Required actionCompare
Enforcement date5/14/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.gov.uk/guidance/notify-mhra-about-a-clinical-inv...
SB-2026-047 P1 Serbia · 5/15/2026 · Guidance New Conditions and Methods of Recognition of Foreign Documents of Conformity (Declaration
Regulated-party impactSerbia updated conditions for recognition of foreign conformity documents for devices.
SB impactSerbia reliance/recognition wizard pathway must reflect new recognition conditions.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsRecognition pathway, foreign conformity document fields, Serbia wizard
Required actionCompare
Enforcement date5/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.alims.gov.rs/wp-content/uploads/2026/05/1a.NOVI-...
SB-2026-048 P1 Serbia · 5/15/2026 · Guidance New Conditions and Methods of Recognition of Foreign Certificates of Conformity of Medical
Regulated-party impactSerbia updated conditions for recognition of foreign conformity certificates for IVDs.
SB impactSerbia IVD recognition wizard pathway must reflect new conditions.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsIVD recognition pathway, certificate fields, Serbia IVD wizard
Required actionCompare
Enforcement date5/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.alims.gov.rs/wp-content/uploads/2026/05/1b.NOVI-...
RegDesk Submission Builder · Confidential Page 11 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 12

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-049 P1 Serbia · 5/15/2026 · Guidance New Conditions and Methods of Recognition of Foreign Documents of Conformity (Declaration
Regulated-party impactSerbia updated conditions for recognition of foreign conformity documents for devices.
SB impactSerbia reliance/recognition wizard pathway must reflect new recognition conditions.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsRecognition pathway, foreign conformity document fields, Serbia wizard
Required actionCompare
Enforcement date5/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.alims.gov.rs/wp-content/uploads/2026/05/2a.NOVI-...
SB-2026-050 P1 Serbia · 5/15/2026 · Guidance New Conditions and Methods of Recognition of Foreign Certificates of Conformity (EC Certif
Regulated-party impactSerbia updated conditions for recognition of foreign conformity certificates for IVDs.
SB impactSerbia IVD recognition wizard pathway must reflect new conditions.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsIVD recognition pathway, certificate fields, Serbia IVD wizard
Required actionCompare
Enforcement date5/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.alims.gov.rs/wp-content/uploads/2026/05/2b.NOVI-...
SB-2026-051 P1 Serbia · 5/15/2026 · Guidance Instructions for Submitting a Request for Amendment/Additional Registration of a Medical D
Regulated-party impactSerbia published instructions for amendment/additional registration submissions.
SB impactSerbia variation/amendment wizard should reflect new submission instructions.
Impact categoryExisting wizard content update
Affected pathwayVariation
Affected elementsAmendment wizard, supporting document requirements
Required actionCompare
Enforcement date5/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.alims.gov.rs/wp-content/uploads/2026/05/4d.-Uput...
SB-2026-052 P1 Czech Republic · 5/18/2026 · Notification Application for Authorization to place a Medical Device on the Market in the Czech Republi
Regulated-party impactCzech Republic updated application procedure for placing MD on market.
SB impactCzech Republic wizard should reflect updated authorization application requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsAuthorization application wizard, Czech Republic
Required actionCompare
Enforcement date5/18/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://sukl.gov.cz/pokyny-ustavu/pokyny-zdravotnicke-prostr...
RegDesk Submission Builder · Confidential Page 12 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 13

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-053 P1 Mexico · 5/19/2026 · Standard Cofepris has published Mexican Official Standard NOM-137-SSA1-2025 - Labeling of Medical D
Regulated-party impactMexico COFEPRIS published NOM-137-SSA1-2025 on labeling of medical devices.
SB impactMexico MD wizard labeling section must be updated to reflect NOM-137-SSA1-2025.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsLabeling fields, NOM standard reference, Mexico wizard
Required actionImplement
Enforcement date5/19/2027
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://diariooficial.gob.mx/nota_detalle.php?codigo=5787790...
SB-2026-060 P1 Peru · 5/21/2026 · Resolution DIGEMID has published Ministerial Resolution No. 193-2026/MINSA
Regulated-party impactPeru DIGEMID published Ministerial Resolution 193-2026/MINSA (details to be confirmed from source).
SB impactReview Peru wizard against Resolution 193-2026/MINSA.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsPeru wizard, registration requirements
Required actionCompare
Enforcement date5/21/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.digemid.minsa.gob.pe/webDigemid/normas-legales/2...
SB-2026-062 P1 Australia · 5/22/2026 · guidance Complying with the Unique Device Identification timeframes for medical devices
Regulated-party impactTGA published/updated UDI compliance timeline guidance.
SB impactAustralia UDI wizard timeline references and compliance milestones should be current.
Impact categoryInstructions/reference update
Affected pathwayUDI
Affected elementsUDI compliance timeline, deadline fields
Required actionCompare
Enforcement dateN/A
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.tga.gov.au/resources/guidance/complying-unique-d...
SB-2026-065 P1 Czech Republic · 5/18/2026 · Notification Methodological Instructions for Submitting an Application for a Free Sale Certificate (FSC
Regulated-party impactCzech Republic updated instructions for Free Sale Certificate applications.
SB impactCzech Republic FSC wizard should reflect new methodological instructions.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsFSC wizard, supporting documents, Czech Republic
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://sukl.gov.cz/pokyny-ustavu/pokyny-zdravotnicke-prostr...
RegDesk Submission Builder · Confidential Page 13 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 14

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-066 P1 Sweden · 5/25/2026 · Guidance Regulations (HSLF-FS 2026:11) amending the Medical Products Agency's regulations (HSLF-FS
Regulated-party impactSweden MPA amending regulation for medical devices.
SB impactSweden wizard regulatory reference update required.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsRegulatory references, Sweden MD wizard
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.lakemedelsverket.se/sv/lagar-och-regler/foreskri...
SB-2026-067 P1 Portugal · 5/20/2026 · Circular Operationalization of EUDAMED on May 28, 2026
Regulated-party impactPortugal INFARMED circular on EUDAMED mandatory use from May 28.
SB impactPortuguese market: Update submission instructions and references to EUDAMED in MDR/IVDR wizards. Confirm SRN/actor registration guidance is current.
Impact categoryInstructions/reference update
Affected pathwayNew registration / UDI
Affected elementsSubmission instructions, EUDAMED references, wizard help text
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.infarmed.pt/documents/15786/12277909/Operacional...
SB-2026-074 P1 Denmark · 5/27/2026 · Notification Distributor and Specialist Store Registration
Regulated-party impactDenmark DKMA notification on distributor and specialist store registration in EUDAMED.
SB impactDenmark wizard for distributor/specialist store actor registration should reflect current EUDAMED requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsActor registration, distributor wizard, EUDAMED references, Denmark
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://laegemiddelstyrelsen.dk/da/udstyr/registrering/regis...
SB-2026-076 P1 Denmark · 5/28/2026 · Notification Registration in Eudamed
Regulated-party impactEUDAMED-related notification.
SB impactReview wizard references to EUDAMED and ensure actor/UDI registration guidance is current.
Impact categoryInstructions/reference update
Affected pathwayUDI / New registration
Affected elementsEUDAMED references, actor registration
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://laegemiddelstyrelsen.dk/da/nyheder/senest-opdaterede...
RegDesk Submission Builder · Confidential Page 14 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 15

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-077 P1 Czech Republic · 5/27/2026 · Notification Temporary Retention of FSC Applications through RZPRO
Regulated-party impactCzech Republic announced temporary retention of FSC applications through RZPRO system.
SB impactCzech Republic FSC wizard submission channel references should reflect RZPRO retention.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsFSC submission channel, Czech Republic
Required actionCompare
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://sukl.gov.cz/zdravotnicke-prostredky/aktuality-zp/doc...
SB-2026-082 P1 Belgium · 5/28/2026 · Notification EUDAMED: Clarifications Regarding Obligations as of 28 May 2026
Regulated-party impactEUDAMED mandatory from May 28, 2026. Manufacturers and economic operators must register actors and devices in EUDAMED.
SB impactManufacturer-facing: Actor registration and UDI/Device registration modules are directly in scope. Market Surveillance module = competent authorities. NB/Cert module = notified bodies. Verify MDR/IVDR device registration wizards reference EUDAMED actor/SRN requirements. Legacy device and SPP pathways need separate review.
Impact categoryExisting wizard content update
Affected pathwayNew registration / UDI
Affected elementsActor registration (SRN), UDI/Device registration data fields, MDR wizard, IVDR wizard, legacy device pathway, SPP pathway
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.fagg.be/nl/news/eudamed_verduidelijkingen_over_d...
SB-2026-083 P1 Slovenia · 5/13/2026 · General informative document Q&A Education May 13, 2026: Obligations of Distributors and Importers
Regulated-party impactSlovenia informational Q&A on distributor/importer obligations under MDR/IVDR.
SB impactSlovenia wizard for distributors/importers should reflect obligations outlined in Q&A.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsDistributor/importer obligations, economic operator wizard, Slovenia
Required actionCompare
Enforcement date5/13/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.jazmp.si/medicinski-pripomocki/splosno-o-medicin...
SB-2026-084 P1 Brazil · 6/1/2026 · Guidance Guidance: Importation via DUIMP_v1.9
Regulated-party impactANVISA updated DUIMP importation guidance to v1.9.
SB impactBrazil import authorization wizard instructions should reference DUIMP v1.9.
Impact categoryInstructions/reference update
Affected pathwayImport authorization
Affected elementsImport instructions, DUIMP reference, Brazil wizard
Required actionCompare
Enforcement date6/1/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicaco...
RegDesk Submission Builder · Confidential Page 15 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 16

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-087 P1 Czech Republic · 6/1/2026 · Guideline Methodological Guideline for the Implementation of MDR Requirements for Custom-Made Device
Regulated-party impactCzech Republic published MDR implementation guideline for custom-made devices.
SB impactCzech Republic custom-made device wizard should reflect new MDR implementation guideline.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsCustom-made device wizard, MDR requirements, Czech Republic
Required actionCompare
Enforcement date6/1/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://sukl.gov.cz/pokyny-ustavu/pokyny-zdravotnicke-prostr...
SB-2026-089 P1 Oman · 6/3/2026 · Regulation Requirements for Approval of Optical Companies Applying for Medical Device Establishment
Regulated-party impactOman MoH published requirements for optical company approval for device registration.
SB impactOman wizard for optical device registrations should reflect new approval requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsOptical device pathway, Oman wizard
Required actionCompare
Enforcement date6/3/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://drive.google.com/file/d/1VCC6GcrOqo03Z-vEWDYfqiHGpef...
SB-2026-091 P1 Switzerland · 6/2/2026 · Guidance Swissdamed Business Rules
Regulated-party impactSwissdamed business rules published. Manufacturers must comply with data submission rules.
SB impactSwitzerland wizard data fields must align with Swissdamed business rules. Validate data dictionary mapping.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsData fields, business rules, validation logic
Required actionCompare
Enforcement date6/2/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
SB-2026-092 P1 Uzbekistan · 5/27/2026 · General alert New legislative changes will come into force in Uzbekistan on June 1
Regulated-party impactUzbekistan legislative changes effective June 1, 2026 affecting medical sector.
SB impactUzbekistan wizard should be reviewed against June 1 legislative changes.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsRegistration requirements, Uzbekistan wizard
Required actionCompare
Enforcement date6/1/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.uzdaily.uz/ru/s-1-iiunia-v-uzbekistane-vstupaiut...
RegDesk Submission Builder · Confidential Page 16 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 17

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-094 P1 Singapore · 6/2/2026 · Guidance GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Groupi
Regulated-party impactSingapore HSA published grouping guidance for medical device registration.
SB impactSingapore MD grouping/bundling logic in wizard should reflect GN-12-1.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsGrouping logic, bundling criteria, Singapore wizard
Required actionCompare
Enforcement date6/2/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.hsa.gov.sg/medical-devices/guidance-documents/#t...
SB-2026-095 P1 South Africa · 6/4/2026 · Guidance Regulatory Requirements for Medical Devices Electronic Instructions for Use (e-IFU)
Regulated-party impactSouth Africa SAHPRA published eIFU regulatory requirements.
SB impactSouth Africa MD wizard labeling/IFU section should include eIFU requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsIFU fields, eIFU eligibility, labeling wizard section
Required actionCompare
Enforcement date6/4/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.sahpra.org.za/document/regulatory-requirements-f...
SB-2026-097 P1 Germany · 5/28/2026 · News European Database for Medical Devices: EUDAMED
Regulated-party impactGermany BfArM/DIMDI EUDAMED mandatory use notification.
SB impactGerman market: Update wizard references to EUDAMED. Confirm actor registration and UDI wizard sections are current.
Impact categoryInstructions/reference update
Affected pathwayNew registration / UDI
Affected elementsEUDAMED references, actor registration help text
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.bfarm.de/DE/Medizinprodukte/Ueberblick/Europa-un...
SB-2026-098 P1 Germany · 5/28/2026 · Notification May 28, 2026: Initial and Amendment Notification MP and IVD
Regulated-party impactGermany updated initial and amendment notification procedures under MDR/IVDR as of May 28 (linked to EUDAMED mandatory use).
SB impactGerman MDR/IVDR new registration and variation wizards should reflect updated notification process.
Impact categoryExisting wizard content update
Affected pathwayNew registration / Variation
Affected elementsNotification fields, EUDAMED references, variation/amendment wizard
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte...
RegDesk Submission Builder · Confidential Page 17 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 18

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-100 P1 Srilanka · 5/21/2026 · Notification Reissuance of Sample Import License (SIL)-Medical Devices
Regulated-party impactSri Lanka updated Sample Import License process for medical devices.
SB impactSri Lanka SIL wizard or import authorization pathway should reflect reissuance process.
Impact categoryExisting wizard content update
Affected pathwayImport authorization
Affected elementsSIL fields, import authorization wizard, Sri Lanka
Required actionCompare
Enforcement dateN/A
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/...
SB-2026-101 P1 Srilanka · 5/21/2026 · Notification Checklist for Document Accepting of Consolidated new Medical Device applications
Regulated-party impactSri Lanka published updated document checklist for new MD applications.
SB impactSri Lanka wizard supporting document requirements should reflect updated checklist.
Impact categoryOfficial form/source-template update
Affected pathwayNew registration
Affected elementsSupporting documents checklist, Sri Lanka wizard
Required actionImplement
Enforcement date7/7/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.nmra.gov.lk/pages/medical-devices
SB-2026-102 P1 Algeria · 5/13/2026 · Guidance Guidelines for Regulatory Trust (Reliance) and Recognition Practices in Good Manufacturing
Regulated-party impactAlgeria published reliance and recognition guidelines.
SB impactAlgeria reliance pathway wizard should reflect new guidelines.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsReliance pathway, recognition criteria
Required actionCompare
Enforcement date5/13/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://anpp.dz/fr/guidelines/
SB-2026-105 P1 Lebanon · 6/9/2026 · Circular Circular No. 23 Regarding FDA-Approved Implantable Medical Devices
Regulated-party impactLebanon circular on FDA-approved implantable devices import requirements.
SB impactLebanon implantable device import wizard may need to reference FDA approval status as a requirement.
Impact categoryExisting wizard content update
Affected pathwayImport authorization
Affected elementsImport authorization, FDA approval evidence, implantable device fields, Lebanon wizard
Required actionCompare
Enforcement date6/9/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.moph.gov.lb/files/laws/files/Tamim_23_2026.pdf
RegDesk Submission Builder · Confidential Page 18 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 19

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-107 P1 Germany · 6/9/2026 · News notification Self-declaration Regarding the Implementation of the Requirements for Writing to the Elect
Regulated-party impactGermany self-declaration requirement for writing-to-address (Schreibweise) under MDR/IVDR.
SB impactGermany MD/IVD wizard should incorporate self-declaration field for writing requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsSelf-declaration field, Germany wizard
Required actionCompare
Enforcement date6/5/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte...
SB-2026-108 P1 Latvia · 5/28/2026 · News notification EUDAMED, The European Database for Medical Devices, Launches
Regulated-party impactLatvia ZVAMC EUDAMED mandatory use announcement.
SB impactLatvian market wizard references to EUDAMED should be current.
Impact categoryInstructions/reference update
Affected pathwayUDI / New registration
Affected elementsSubmission instructions
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.zva.gov.lv/lv/jaunumi-un-publikacijas/jaunumi/da...
SB-2026-109 P1 Luxembourg · 5/28/2026 · Medical Device news Mandatory use of EUDAMED from May 28, 2026
Regulated-party impactLuxembourg mandatory EUDAMED use from May 28, 2026.
SB impactLuxembourg wizard references and submission instructions should reflect mandatory EUDAMED use.
Impact categoryInstructions/reference update
Affected pathwayUDI / New registration
Affected elementsSubmission instructions, wizard help text
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://santesecu.public.lu/fr/espace-professionnel/departem...
SB-2026-112 P1 China · 6/1/2026 · Notification China NMPA Issues Announcement on Medical Device Classification Adjustment Procedures
Regulated-party impactChina NMPA announced classification adjustments for medical devices.
SB impactChina wizard classification logic must reflect adjusted classifications.
Impact categoryConditional logic or pathway update
Affected pathwayClassification
Affected elementsClassification wizard, device classification logic, China
Required actionCompare
Enforcement date6/1/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/202606...
RegDesk Submission Builder · Confidential Page 19 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 20

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-115 P1 Hungary · 6/10/2026 · Notification Deviation from Conformity Assessment Procedures
Regulated-party impactHungary OGYÉI notification on deviations from conformity assessment procedures.
SB impactHungary MD wizard conformity assessment section should note deviation procedure.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsConformity assessment, deviation pathway, Hungary wizard
Required actionCompare
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://ogyei.gov.hu/a_megfelelosegertekelesi_eljarasoktol_v...
SB-2026-116 P1 Hungary · 6/10/2026 · Notification Conformity Assessment Bodies
Regulated-party impactHungary OGYÉI notification on conformity assessment bodies.
SB impactHungary wizard NB/conformity assessment body references may need updating.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsNB references, conformity assessment, Hungary wizard
Required actionCompare
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://ogyei.gov.hu/megfelelosegertekelo_szervezetek
SB-2026-117 P1 United Kingdom · 6/11/2026 · Guidance Regulation of Medical Devices in Northern Ireland
Regulated-party impactMHRA updated Northern Ireland device regulation guidance.
SB impactUK/Northern Ireland wizard pathway should reflect current MDR/IVDR NI rules.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsNorthern Ireland pathway, UKNI marking, Windsor Framework logic
Required actionCompare
Enforcement date6/11/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.gov.uk/guidance/medical-devices-eu-regulations-f...
SB-2026-118 P1 Korea · 6/10/2026 · Guidance Labeling Guideline for Digital Medical Devices
Regulated-party impactKorea MFDS published labeling guideline for digital medical devices (SaMD).
SB impactKorea SaMD/digital device wizard labeling section must be reviewed.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsDigital device labeling fields, SaMD wizard
Required actionCompare
Enforcement date6/10/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.mfds.go.kr/brd/m_1060/view.do?seq=15870&srchFr=&...
RegDesk Submission Builder · Confidential Page 20 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 21

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-120 P1 Hong Kong · 6/12/2026 · Guidance GN-02: Guidance Notes for Listing Class II/III/IV General Medical Devices
Regulated-party impactHong Kong updated guidance for listing Class II/III/IV general medical devices.
SB impactHong Kong MD listing wizard must reflect updated GN-02 requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsMD listing wizard, Class II/III/IV fields, supporting documents
Required actionCompare
Enforcement date6/12/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.mdd.gov.hk/tc/whats-new/mdacs-activities/index-i...
SB-2026-121 P1 Hong Kong · 6/12/2026 · Guidance GN-06: Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices
Regulated-party impactHong Kong updated guidance for listing Class B/C/D IVDs.
SB impactHong Kong IVD listing wizard must reflect updated GN-06 requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsIVD listing wizard, Class B/C/D fields, supporting documents
Required actionCompare
Enforcement date6/12/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.mdd.gov.hk/tc/whats-new/mdacs-activities/index-i...
SB-2026-122 P1 Brazil · 6/12/2026 · Circular ANVISA Expands Support and Improvement Measures to Support the Transition to the New Impor
Regulated-party impactANVISA expanded support for SIUD/RDC 751 transition.
SB impactBrazil UDI/SIUD wizard transition references should be updated.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsUDI transition, SIUD wizard, Brazil
Required actionCompare
Enforcement date6/12/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/202...
SB-2026-123 P1 Kyrgyzstan · 6/8/2026 · Government's Decree On Amendments to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic “On App
Regulated-party impactKyrgyzstan amended cabinet resolution on medical device registration.
SB impactKyrgyzstan wizard should be reviewed against amended resolution.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsRegistration requirements, Kyrgyzstan wizard
Required actionCompare
Enforcement date6/18/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://cbd.minjust.gov.kg/7-55651/edition/54132/ru
RegDesk Submission Builder · Confidential Page 21 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 22

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-125 P1 Mexico · 6/17/2026 · Guidance Cofepris has published an update to the Guide to Requirements for the Sanitary Registratio
Regulated-party impactMexico COFEPRIS updated requirements guide for sanitary registration of medical devices.
SB impactMexico MD registration wizard should be reviewed against updated COFEPRIS requirements guide.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsRegistration requirements, supporting documents, Mexico wizard
Required actionCompare
Enforcement date6/17/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.gob.mx/cms/uploads/attachment/file/1084062/GUIA_...
SB-2026-127 P1 Canada · 6/17/2026 · Bulletin Phase 2 of our Work to Modernize Medical Device Establishment Licensing
Regulated-party impactHealth Canada Phase 2 of modernized Medical Device Establishment Licensing.
SB impactCanada MDEL wizard should reflect Phase 2 modernization changes.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsMDEL wizard, establishment licensing fields, Canada
Required actionCompare
Enforcement date12/14/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.canada.ca/en/health-canada/services/drugs-health...
SB-2026-129 P1 Belarus · 6/16/2026 · Notification Transfer of Medical Device Regulatory Functions in Belarus
Regulated-party impactBelarus transferred MD regulatory functions to a new authority.
SB impactBelarus wizard regulatory authority references and submission addresses must be updated.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsRegulatory authority name, submission address, Belarus wizard
Required actionImplement
Enforcement date6/30/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://rceth.by/ru/News/1918
SB-2026-130 P1 Switzerland · 6/18/2026 · Guidance Swissdamed User Manual Actors
Regulated-party impactSwitzerland mandatory Swissdamed use from July 1, 2026. Actors must register in Swissdamed.
SB impactSwitzerland wizard must cover Swissdamed actor registration pathway. Separate assessments needed for: MD, IVD, SPP, legacy devices, transitional registrations, immediate registration exception (serious incidents/FSCA), per-UDI-DI fees.
Impact categoryExisting wizard content update
Affected pathwayNew registration / Actor registration
Affected elementsActor registration, SRN equivalent, MD registration pathway, IVD pathway, SPP pathway, legacy device pathway, transitional rules, immediate registration trigger, fee fields
Required actionImplement
Enforcement date6/15/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
RegDesk Submission Builder · Confidential Page 22 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 23

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-131 P1 Rwanda · 6/18/2026 · Regulation Regulations Governing Good Manufacturing Practices of Medical Products
Regulated-party impactRwanda published GMP regulations for medical products including devices.
SB impactRwanda wizard QMS/GMP evidence section should reflect new GMP regulations.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsGMP evidence, QMS section, Rwanda wizard
Required actionCompare
Enforcement date6/18/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://rwandafda.gov.rw/monitoring-tool/documents-managemen...
SB-2026-132 P1 Botswana · 6/18/2026 · Announcement BOMRA Medical Devices, including IVDs, Regulatory Update: Medical Device Regulatory Strate
Regulated-party impactBotswana BOMRA published regulatory update for MD and IVDs.
SB impactAssess Botswana wizard coverage against BOMRA regulatory update.
Impact categoryNew wizard or coverage-gap assessment
Affected pathwayNew registration
Affected elementsBotswana wizard coverage gap assessment
Required actionMonitor
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.bomra.co.bw/bomra-medical-devices-including-ivds...
SB-2026-133 P1 Switzerland · 6/19/2026 · Notification New Options for Product Registration in Swissdamed: Online Editor and M2M Interface, and R
Regulated-party impactSwissdamed online editor and M2M interface available for product registration.
SB impactSwitzerland wizard submission instructions should reference online editor and M2M options.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsSubmission instructions, wizard help text
Required actionCompare
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.swissmedic.ch/swissmedic/de/home/medizinprodukte...
SB-2026-137 P1 Switzerland · 6/19/2026 · Guidance User Manual Swissdamed UDI Device Module
Regulated-party impactSwissdamed UDI Device module user manual published. Manufacturers must submit UDI data in Swissdamed.
SB impactSwitzerland UDI wizard section must align with Swissdamed UDI Device module requirements and data fields.
Impact categoryExisting wizard content update
Affected pathwayUDI
Affected elementsUDI data fields, UDI/Device module, Swissdamed UDI submission
Required actionCompare
Enforcement date6/19/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
RegDesk Submission Builder · Confidential Page 23 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 24

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-140 P1 European Union · 6/18/2026 · Guidance MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
Regulated-party impactEUDAMED-related notification.
SB impactReview wizard references to EUDAMED and ensure actor/UDI registration guidance is current.
Impact categoryInstructions/reference update
Affected pathwayUDI / New registration
Affected elementsEUDAMED references, actor registration
Required actionCompare
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://health.ec.europa.eu/document/download/a80332cf-e9f0-...
SB-2026-142 P1 Mexico · 6/22/2026 · Announcement Update on the Reliance Regulatory Fast Track Platform
Regulated-party impactMexico updated reliance regulatory fast track platform.
SB impactMexico reliance/fast track pathway wizard should reflect platform updates.
Impact categoryConditional logic or pathway update
Affected pathwayNew registration
Affected elementsReliance pathway, fast track selection, Mexico wizard
Required actionCompare
Enforcement date6/19/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.gob.mx/cofepris/acciones-y-programas/via-regulat...
SB-2026-143 P1 Korea · 6/23/2026 · Enforcement Decree Enforcement Decree of the Medical Device Act
Regulated-party impactKorea Enforcement Decree of the Medical Device Act updated.
SB impactKorea MD wizard pathway and eligibility logic should be reviewed against updated Enforcement Decree.
Impact categoryExisting wizard content update
Affected pathwayNew registration / Variation
Affected elementsPathway eligibility, exemptions, classification, submission requirements
Required actionCompare
Enforcement date7/1/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%98%EB%A3%8C%...
SB-2026-146 P1 Australia · 6/24/2026 · Guidance Complying with the Unique Device Identification timeframes for medical devices
Regulated-party impactTGA published/updated UDI compliance timeline guidance.
SB impactAustralia UDI wizard timeline references and compliance milestones should be current.
Impact categoryInstructions/reference update
Affected pathwayUDI
Affected elementsUDI compliance timeline, deadline fields
Required actionCompare
Enforcement dateN/A
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.tga.gov.au/resources/guidance/complying-unique-d...
RegDesk Submission Builder · Confidential Page 24 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 25

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-147 P1 Australia · 6/24/2026 · Notification Unique Device Identification Consent to Supply process
Regulated-party impactTGA Consent to Supply (CTS) process updated in context of UDI requirements.
SB impactAustralia Consent to Supply pathway is separate from UDI pathway — should not be grouped under UDI wizard. Review CTS-specific fields and UDI linkage.
Impact categoryConditional logic or pathway update
Affected pathwayImport authorization
Affected elementsConsent to Supply pathway, CTS wizard, UDI linkage in CTS, import authorization fields
Required actionCompare
Enforcement dateN/A
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.tga.gov.au/products/medical-devices/labelling-an...
SB-2026-151 P1 Kazakhstan · 6/24/2026 · Law Law of Kazakhstan On Amendments and Supplements to Certain Legislative Acts of the Republ
Regulated-party impactKazakhstan enacted law amending legislative acts related to medical devices.
SB impactKazakhstan wizard should be reviewed against new law amendments.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsRegistration requirements, pathway, Kazakhstan wizard
Required actionCompare
Enforcement date6/24/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://continent-online.com/Document/?doc_id=35487579#pos=2...
SB-2026-152 P1 South Africa · 6/25/2026 · Guidance Communication on Research Use Only (RUO) and Investigational Use Only (IUO) Medical Device
Regulated-party impactSAHPRA published communication on RUO/IUO devices and the GLF-MD-25A form update.
SB impactSouth Africa RUO/IUO wizard or registration form must be updated to reflect GLF-MD-25A. This is a concrete form update, not just a communication.
Impact categoryOfficial form/source-template update
Affected pathwayNew registration
Affected elementsGLF-MD-25A form, RUO/IUO classification, South Africa wizard form fields
Required actionImplement
Enforcement date6/25/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.sahpra.org.za/document/communication-on-research...
SB-2026-154 P1 China · 6/23/2026 · Guidance China's NMPA Issues 2026 Revised Registration Review Guidelines for Medical MRI Systems
Regulated-party impactChina NMPA revised registration review guidelines for MRI devices.
SB impactChina MRI device technical review section in wizard should reflect 2026 revised guidelines.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsMRI device technical requirements, China wizard
Required actionCompare
Enforcement date6/23/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.cmde.org.cn/xwdt/shpgzgg/gztg/20260623092501160....
RegDesk Submission Builder · Confidential Page 25 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 26

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-155 P1 China · 6/18/2026 · Notification China's NMPA Releases Technical Review Guidelines for Varicose Vein Closure Adhesive Devic
Regulated-party impactChina NMPA issued technical review guidelines for varicose vein closure adhesives.
SB impactChina wizard for relevant product type should reference new guidelines.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsProduct-specific technical requirements, China wizard
Required actionCompare
Enforcement date6/18/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/xwdt/shpgzgg/gztg/20260618145109105....
SB-2026-156 P1 China · 6/15/2026 · Notification China's NMPA Issues Trial Technical Review Guidelines for Tumor Gene Variant Detection Rea
Regulated-party impactChina NMPA issued trial technical review guidelines for tumor gene variant detection IVDs.
SB impactChina IVD wizard for oncology diagnostics should reference new guidelines.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsIVD technical requirements, oncology diagnostics section, China wizard
Required actionCompare
Enforcement date6/15/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/xwdt/shpgzgg/gztg/20260615154311124....
SB-2026-157 P1 India · 6/24/2026 · Circular Sale of In-Vitro Fertilization Media, Reagents, and Related Consumables Used Assisted Repr
Regulated-party impactIndia circular on sale of IVF media, reagents, and related consumables (IVD-related).
SB impactIndia IVD wizard for IVF-related products should reflect regulatory requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsIVD wizard, IVF consumables, India
Required actionCompare
Enforcement date6/24/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WE...
SB-2026-158 P1 Korea · 6/23/2026 · Guidance Enforcement Decree of the Medical Device Act
Regulated-party impactKorea Enforcement Decree of the Medical Device Act updated.
SB impactKorea MD wizard pathway and eligibility logic should be reviewed against updated Enforcement Decree.
Impact categoryExisting wizard content update
Affected pathwayNew registration / Variation
Affected elementsPathway eligibility, exemptions, classification, submission requirements
Required actionCompare
Enforcement date7/1/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%98%EB%A3%8C%...
RegDesk Submission Builder · Confidential Page 26 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 27

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-160 P1 Brazil · 6/25/2026 · Regulation TECHNICAL NOTE Nº 41/2026/SEI/GQUIP/GGTPS/DIRE3/ANVISA
Regulated-party impactANVISA Technical Note 41/2026 on device registration (details to be confirmed).
SB impactReview Brazil wizard against ANVISA Technical Note 41/2026.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsBrazil wizard, registration requirements
Required actionCompare
Enforcement date6/25/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/...
SB-2026-161 P1 Korea · 6/26/2026 · Guidance Approval and Review Guideline for Digital Medical Device Change Control Plans
Regulated-party impactKorea MFDS published change control plan guideline for digital medical devices.
SB impactKorea digital device (SaMD) variation/change notification wizard should incorporate change control plan requirements.
Impact categoryConditional logic or pathway update
Affected pathwayVariation
Affected elementsChange control plan fields, SaMD variation wizard, digital device change categories
Required actionCompare
Enforcement date6/26/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.mfds.go.kr/brd/m_1060/view.do?seq=15874&srchFr=&...
SB-2026-162 P1 Kyrgyzstan · 6/18/2026 · Resolution of the Cabinet of Ministers of Kyrgyzstan On Amendments to the Resolution of the Government of the Kyrgyz Republic "On the Procedure
Regulated-party impactKyrgyzstan amended government resolution on device registration (EAEU alignment).
SB impactKyrgyzstan wizard should reflect amended resolution requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsRegistration pathway, EAEU alignment, Kyrgyzstan wizard
Required actionCompare
Enforcement date6/28/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://cbd.minjust.gov.kg/7-56066/edition/54901/ru
SB-2026-163 P1 Oman · 6/28/2026 · Circular Extension of Registration Period for High-Risk Medical Devices and Supplies Manufacturers
Regulated-party impactOman extended registration period for high-risk devices.
SB impactOman renewal wizard timeline references should reflect extended registration period.
Impact categoryInstructions/reference update
Affected pathwayRenewal
Affected elementsRenewal wizard, registration period, Oman
Required actionCompare
Enforcement date6/28/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.moh.gov.om/media/zisn2dzq/cirno64-of-2026-regard...
RegDesk Submission Builder · Confidential Page 27 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 28

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-164 P1 Malaysia · 6/1/2026 · Notification Malaysia MDA: Fully Online Product Classification Application (effective Aug 1, 2026)
Regulated-party impactManufacturers must submit Product Classification applications fully online from Aug 1, 2026.
SB impactMalaysia Product Classification wizard must be updated for fully online submission channel, new/renewal pathway logic, repeatable product fields, attachments, fees, and output instructions.
Impact categoryConditional logic or pathway update
Affected pathwayClassification
Affected elementsSubmission channel, new/renewal pathway, repeatable products, attachment fields, fee references, output instructions, Malaysia classification wizard
Required actionImplement
Enforcement date8/1/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.mda.gov.my
SB-2026-003 P2 Mexico · 5/4/2026 · Agreement Cofepris has published the “Agreement establishing measures to streamline procedures filed
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/15/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://diariooficial.gob.mx/nota_detalle.php?codigo=5786603...
SB-2026-004 P2 Mexico · 5/4/2026 · Agreement Cofepris has published the “Agreement Updating the Methods for Submitting Applications COF
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/5/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://diariooficial.gob.mx/nota_detalle.php?codigo=5786604...
SB-2026-005 P2 Iraq · 5/6/2026 · Circular Circular to Scientific Offices and Companies
Regulated-party impactIraq circular to scientific offices and medical device companies.
SB impactReview for specific MD registration requirements. Iraq wizard references may need updating.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsIraq wizard references
Required actionCompare
Enforcement date5/6/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://drive.google.com/file/d/1OWLp6Q83DnLyBrwG4mUFT_VyB-7...
RegDesk Submission Builder · Confidential Page 28 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 29

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-012 P2 Chile · 5/7/2026 · Resolution Exempt Resolution No. 2.050/2026 approves the “Guidelines for Clinical Trials of Medical D
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/7/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.ispch.cl/wp-content/uploads/2026/05/Guia-Inv.Cli...
SB-2026-013 P2 Chile · 5/6/2026 · Announcement ISP Announces New Certification Program for Domestic and Innovative Medical Device Manufac
Regulated-party impactChile ISP launched new certification program for domestic/innovative devices.
SB impactAssess whether Chile wizard covers new certification pathway for domestic/innovative devices.
Impact categoryNew wizard or coverage-gap assessment
Affected pathwayNew registration
Affected elementsNew certification pathway, Chile wizard coverage gap
Required actionMonitor
Enforcement date5/6/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.ispch.cl/noticia/isp-informa-sobre-nueva-prestac...
SB-2026-015 P2 United States · 5/6/2026 · Guidance Patient-Matched Guides for Orthopedic Implants
Regulated-party impactManufacturers of patient-matched orthopedic implants must follow FDA guidance on design controls, labeling, and 510(k)/De Novo submissions.
SB impactReview IVD/nIVD eSTAR wizard sections for patient-matched/custom devices. Guidance may require new conditional questions about patient-matching process.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsCustom device questions, design control section, labeling fields
Required actionCompare
Enforcement date5/7/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.fda.gov/regulatory-information/search-fda-guidan...
SB-2026-018 P2 Switzerland · 5/1/2026 · Guidance Manufacturer Incident Report Guideline
Regulated-party impactSwitzerland updated manufacturer incident report guideline.
SB impactSwitzerland PMS/vigilance wizard or instructions should reference updated incident report guideline.
Impact categoryExisting wizard content update
Affected pathwayPost-market/vigilance
Affected elementsIncident report fields, vigilance section
Required actionCompare
Enforcement date5/1/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
RegDesk Submission Builder · Confidential Page 29 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 30

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-019 P2 Switzerland · 5/1/2026 · Guidance Information Sheet Combined Studies
Regulated-party impactSwitzerland information sheet on combined studies (device + other).
SB impactSwitzerland clinical investigation wizard may reference updated combined study requirements.
Impact categoryInstructions/reference update
Affected pathwayClinical investigation
Affected elementsCombined study wizard, clinical investigation references
Required actionCompare
Enforcement date5/1/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
SB-2026-025 P2 Algeria · 5/10/2026 · Notice Note No. 41 to Pharmaceutical Establishment and Economic Operators Relating to Requests fo
Regulated-party impactAlgeria regulatory notice to pharmaceutical establishments and economic operators.
SB impactReview for MD-specific requirements. Algeria MD wizard may need reference update.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsAlgeria wizard references
Required actionCompare
Enforcement date5/10/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://drive.google.com/file/d/1oqkumGkZqFPWEfUdLA8nkXH8e1a...
SB-2026-027 P2 Hong Kong · 5/13/2026 · Guidance GN-00: Definitions and Abbreviations for the Medical Device Administrative Control System
Regulated-party impactHong Kong updated definitions and abbreviations guidance for MDACS.
SB impactHong Kong wizard terminology and field labels should align with GN-00.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsField labels, definitions, wizard help text
Required actionCompare
Enforcement date5/13/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.mdd.gov.hk/filemanager/common/mdacs/GN-00-E.pdf
SB-2026-029 P2 Turkey · 5/13/2026 · Guidance Guidelines for Registration Processes of Medical Devices in the Product Tracking System
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/13/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.titck.gov.tr/duyuru/tibbi-cihazlarin-urun-takip-...
RegDesk Submission Builder · Confidential Page 30 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 31

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-031 P2 Paraguay · 5/13/2026 · Resolution DINAVISA has published Resolution No. 189/2026
Regulated-party impactParaguay DINAVISA published Resolution 189/2026 (details to be confirmed from source).
SB impactReview Paraguay wizard against Resolution 189/2026 requirements.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsParaguay MD wizard sections
Required actionCompare
Enforcement date5/13/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://dinavisa.gov.py/wp-content/uploads/2026/05/RESOLUCIO...
SB-2026-032 P2 United Kingdom · 5/11/2026 · Notification MHRA invites Views on Proposed Changes to Medical Device Regulation
Regulated-party impactMHRA consultation on proposed changes to UK MD regulation.
SB impactMonitor consultation outcome. No wizard change until final regulation published.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsAll UK MD wizard sections potentially affected
Required actionMonitor
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.gov.uk/government/news/mhra-invites-views-on-pro...
SB-2026-034 P2 Finland · 5/11/2026 · Notification Medical Device Manufacturers must report Serious Incidents using a New Form
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date—
Confidence · ValidationLow · Pending human validation
Official sourcehttps://fimea.fi/-/laakinnallisten-laitteiden-valmistajien-o...
SB-2026-036 P2 Australia · 5/12/2026 · Guidance Preparing for an application audit for in-vitro diagnostic medical devices
Regulated-party impactTGA guidance on preparing for IVD application audits.
SB impactAustralia IVD wizard audit preparation references may need updating.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsIVD wizard, audit preparation section, supporting documents
Required actionCompare
Enforcement dateN/A
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.tga.gov.au/resources/guidance/preparing-applicat...
RegDesk Submission Builder · Confidential Page 31 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 32

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-040 P2 Peru · 5/15/2026 · Announcement DIGEMID - Announcement No. 006/2026
Regulated-party impactPeru DIGEMID announcement (details to be confirmed).
SB impactReview Peru wizard against DIGEMID Announcement 006/2026.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsPeru wizard references
Required actionCompare
Enforcement date5/26/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.digemid.minsa.gob.pe/webDigemid/comunicados/2026...
SB-2026-044 P2 China · 5/8/2026 · Guidance China NMPA Issues Guidance on Registration Review for Percutaneous Coronary Intervention P
Regulated-party impactChina NMPA issued final guidance for percutaneous coronary intervention devices.
SB impactChina wizard product-specific technical review section for PCI devices should reference new guidance.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsPCI device technical requirements, China wizard
Required actionCompare
Enforcement date5/8/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/xwdt/shpgzgg/gztg/20260508154726128....
SB-2026-045 P2 Ireland · 5/13/2026 · Guidance Guide to Pre-submission Scientific and Regulatory Advice for GXP Activities
Regulated-party impactIreland HPRA guide on pre-submission advice for GXP activities.
SB impactIreland wizard pre-submission/scientific advice references may need updating.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsPre-submission advice references, Ireland wizard
Required actionCompare
Enforcement date5/13/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://assets.hpra.ie/data/docs/default-source/external-gui...
SB-2026-059 P2 Mexico · 5/21/2026 · Guidelines Guidelines for promoting National Investment in the production of Medicines, Health Produc
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/22/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://diariooficial.gob.mx/nota_detalle.php?codigo=5788117...
RegDesk Submission Builder · Confidential Page 32 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 33

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-061 P2 Kazakhstan · 5/19/2026 · MOH Order Order of the Minister of Health of the Republic of Kazakhstan from May 13, 2026 No. 50
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/29/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://api.gos24.kz/news/8581?title=%D0%A1+29+%D0%BC%D0%B0%...
SB-2026-063 P2 Australia · 5/12/2026 · Notification Preparing for an application audit for in-vitro diagnostic medical devices
Regulated-party impactTGA guidance on preparing for IVD application audits.
SB impactAustralia IVD wizard audit preparation references may need updating.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsIVD wizard, audit preparation section, supporting documents
Required actionCompare
Enforcement dateN/A
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.tga.gov.au/resources/guidance/preparing-applicat...
SB-2026-068 P2 Korea · 5/26/2026 · Guidance for officials Approval and Review Procedures for New Technology Medical Devices
Regulated-party impactKorea MFDS updated approval and review procedures for new technology medical devices.
SB impactKorea new technology MD registration wizard should reflect updated review procedures.
Impact categoryExisting wizard content update
Affected pathwayNew registration
Affected elementsNew technology device pathway, review procedure fields
Required actionCompare
Enforcement date5/26/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.mfds.go.kr/brd/m_1059/view.do?seq=15241&srchFr=&...
SB-2026-069 P2 Switzerland · 5/26/2026 · Notification Template Trend Report
Regulated-party impactSwitzerland updated trend report template.
SB impactIf SB includes Swiss PMS reporting, update trend report template reference.
Impact categoryOfficial form/source-template update
Affected pathwayPost-market/vigilance
Affected elementsTrend report template, PMS wizard
Required actionCompare
Enforcement date5/26/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
RegDesk Submission Builder · Confidential Page 33 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 34

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-070 P2 Switzerland · 5/26/2026 · Notification Template PSR Report
Regulated-party impactSwitzerland updated PSR (Periodic Safety Report) template.
SB impactIf SB includes Swiss PSR reporting, update PSR template reference.
Impact categoryOfficial form/source-template update
Affected pathwayPost-market/vigilance
Affected elementsPSR template, PMS wizard
Required actionCompare
Enforcement date5/26/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
SB-2026-071 P2 South Africa · 5/26/2026 · Guidance Guideline on How to Respond to a GMP, GWP, GCP or GVP Inspection Report
Regulated-party impactSAHPRA guideline on responding to GMP/GWP/GCP/GVP inspection reports.
SB impactSouth Africa QMS/GMP evidence wizard references may need updating. GCP/GVP aspects are pharma-focused; GMP/GWP are MD-relevant.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsGMP evidence section, inspection response references
Required actionCompare
Enforcement date5/26/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://sahpraza.sharepoint.com/:b:/s/SAHPRAwebsitePublicDoc...
SB-2026-072 P2 Korea · 5/28/2026 · Guidance FAQs for Medical Device Non-clinical Trials Guidance
Regulated-party impactKorea MFDS FAQ on non-clinical trial guidance for devices.
SB impactKorea wizard technical evidence section may reference updated non-clinical testing guidance.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsNon-clinical test evidence section, technical file
Required actionCompare
Enforcement date5/28/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.mfds.go.kr/brd/m_1060/view.do?seq=15861&srchFr=&...
SB-2026-075 P2 Denmark · 5/28/2026 · Notification Registration
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/28/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://laegemiddelstyrelsen.dk/da/udstyr/registrering/
RegDesk Submission Builder · Confidential Page 34 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 35

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-078 P2 Cameroon · 5/29/2026 · Circular Implementation of a combined Individual Case Safety Report (ICSR)/line listing system for
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/29/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://dpml.cm/index.php/fr/sinformer/actualite/annee-2026/...
SB-2026-079 P2 Iraq · 5/31/2026 · Circular Announcement from the Pharmacy Department, Private Sector Division, to All Scientific Offi
Regulated-party impactIraq pharmacy department announcement to scientific offices.
SB impactReview Iraq wizard for relevant updates.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsIraq wizard
Required actionMonitor
Enforcement date6/1/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://drive.google.com/file/d/1GNEBUgmEXgwg7N-tVOulTp7ckEh...
SB-2026-080 P2 Singapore · 5/28/2026 · Announcement How Medical Devices are Regulated by HSA and their Safe Use
Regulated-party impactSingapore HSA informational publication on device regulation.
SB impactNo immediate SB action — informational only.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsWizard references
Required actionMonitor
Enforcement date5/28/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.hsa.gov.sg/announcements/how-medical-devices-are...
SB-2026-085 P2 Argentina · 6/1/2026 · Announcement Update on fees for ANMAT procedures
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date6/1/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.argentina.gob.ar/noticias/actualizacion-de-aranc...
RegDesk Submission Builder · Confidential Page 35 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 36

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-088 P2 Syria · 6/3/2026 · Regulation Regulatory Decision 8/T
Regulated-party impactSyria regulatory decision 8/T (details limited).
SB impactInsufficient data to confirm SB impact. Requires manual review.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsSyria wizard
Required actionEscalate
Enforcement date6/3/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://drive.google.com/file/d/1ddRBamOZbzRoilCES_skJN3jq3N...
SB-2026-090 P2 Iraq · 6/3/2026 · Circular Circular No. 9/2/1163 To All Scientific Offices and National Factories
Regulated-party impactIraq circular to scientific offices and national manufacturers.
SB impactReview for specific requirements affecting Iraq wizard.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsIraq wizard
Required actionMonitor
Enforcement date6/7/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://drive.google.com/file/d/1hGYn_qkKNyiXhTBRPQWnMKq1REx...
SB-2026-093 P2 Uzbekistan · 5/5/2026 · President's Decree On measures to provide additional support to the private sector in the medical field
Regulated-party impactUzbekistan presidential decree on private sector support in medical field.
SB impactMonitor for any device-specific regulatory changes resulting from this decree.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsUzbekistan wizard
Required actionMonitor
Enforcement date5/7/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.norma.uz/novoe_v_zakonodatelstve/novye_vozmojnos...
SB-2026-096 P2 Uzbekistan · 5/25/2026 · Legal act Departmental regulatory legal act on the procedure for conducting inspection control of pr
Regulated-party impactUzbekistan inspection control procedure regulation.
SB impactUzbekistan wizard GMP/inspection evidence section may need updating.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsInspection evidence, Uzbekistan wizard
Required actionCompare
Enforcement date6/3/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://yuz.uz/ru/news/v-uzbekistane-ustanovlen-poryadok-ins...
RegDesk Submission Builder · Confidential Page 36 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 37

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-099 P2 United States · 6/5/2026 · Guidance Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirem
Regulated-party impactFDA signals intent to exempt certain unclassified devices from 510(k). Manufacturers of affected devices may be reclassified.
SB impactMonitor for final rule. If exemptions finalized, classification pathway logic for affected device types may need updating.
Impact categoryConditional logic or pathway update
Affected pathwayClassification
Affected elementsDevice classification wizard, 510(k) pathway eligibility logic
Required actionMonitor
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.fda.gov/media/89238/download
SB-2026-106 P2 Switzerland · 6/8/2026 · Guidance Swissdamed Machine-to-Machine REST API Technical Documentation
Regulated-party impactSwissdamed M2M REST API documented for automated submissions.
SB impactIf SB supports M2M submission to Swissdamed, API integration must follow published technical documentation.
Impact categoryExport/XML/data-mapping update
Affected pathwayNew registration
Affected elementsAPI integration, M2M export format, authentication
Required actionMonitor
Enforcement date6/5/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
SB-2026-124 P2 China · 6/5/2026 · Notification China’s NMPA Announces Removal of 10 Medical Device Industry Standards, Including Transcat
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date6/5/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxhybzhgg/20260...
SB-2026-126 P2 Peru · 6/17/2026 · Announcement Announcement No. 008/2026 - Webinar on the Medical Device Risk Management Report
Regulated-party impactPeru DIGEMID webinar on MD risk management (ISO 14971).
SB impactReview Peru wizard risk management evidence section against DIGEMID expectations.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsRisk management section, ISO 14971 references, Peru wizard
Required actionMonitor
Enforcement date6/25/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.digemid.minsa.gob.pe/webDigemid/comunicados/2026...
RegDesk Submission Builder · Confidential Page 37 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 38

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-128 P2 Saudi Arabia · 6/18/2026 · Announcement Standard Specification Annex No. (1) of the Technical Regulation for Communications and In
Regulated-party impactSaudi Arabia standard specification annex for communication technologies in medical devices.
SB impactMonitor — may affect technical specifications section for connected/communication-enabled devices.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsTechnical specifications, connected device fields
Required actionMonitor
Enforcement date11/1/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://drive.google.com/file/d/10dstW9MxHscAWGiYnmxCNIeQ4oz...
SB-2026-134 P2 Switzerland · 6/19/2026 · Notification Amendment to the Swissmedic Fee Ordinance as of July 1, 2026
Regulated-party impactSwissmedic fee ordinance amended as of July 1, 2026. Per-UDI-DI fees apply.
SB impactSwitzerland wizard should reflect updated fee schedule and per-UDI-DI fee logic.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsFee fields, fee schedule references
Required actionCompare
Enforcement date7/1/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.swissmedic.ch/swissmedic/de/home/news/mitteilung...
SB-2026-135 P2 Switzerland · 6/19/2026 · Guidance Procurement of Medical Devices in Healthcare Facilities
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date5/19/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
SB-2026-136 P2 Switzerland · 6/19/2026 · Guidance Swissdamed User Guide - Playground
Regulated-party impactSwissdamed playground environment available for testing.
SB impactOperational note for SB implementation/testing team — playground can be used to validate Swissdamed submissions.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsTesting instructions
Required actionMonitor
Enforcement date6/19/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizi...
RegDesk Submission Builder · Confidential Page 38 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 39

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-138 P2 Sweden · 6/17/2026 · News The Swedish Medicines Agency will be responsible for AI systems in medical devices.
Regulated-party impactSweden MPA to take responsibility for AI systems in medical devices.
SB impactMonitor — may affect SaMD/AI-MD wizard classification and regulatory pathway in Sweden.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsAI/SaMD pathway, Sweden wizard
Required actionMonitor
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.lakemedelsverket.se/sv/nyheter/lakemedelsverket-...
SB-2026-139 P2 European Union · 6/17/2026 · Guidance Guidance on standardisation for medical devices
Regulated-party impactEU guidance on use of harmonized standards for conformity assessment.
SB impactMay affect standards references in EU MDR/IVDR technical file wizard sections.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsStandards references, essential requirements section, harmonized standards list
Required actionMonitor
Enforcement date—
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://health.ec.europa.eu/document/download/59ac4cb0-f187-...
SB-2026-141 P2 Bahrain · 6/9/2026 · Circular Updated Fee Schedules of Services and Requests for Medical Devices and Products in the Nat
Regulated-party impactBahrain NHRA updated fee schedule for MD services.
SB impactUpdate Bahrain wizard fee references if fee information is included in wizard.
Impact categoryInstructions/reference update
Affected pathwayNew registration
Affected elementsFee fields, fee schedule references
Required actionCompare
Enforcement date6/9/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.nhra.bh/Departments/MDR/MediaHandler/GenericHand...
SB-2026-144 P2 Australia · 6/22/2026 · Notification New UDI Newsletter
Regulated-party impactTGA UDI newsletter published.
SB impactReview for any actionable UDI updates. Update wizard references if needed.
Impact categoryInstructions/reference update
Affected pathwayUDI
Affected elementsUDI wizard references
Required actionMonitor
Enforcement dateN/A
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.tga.gov.au/products/medical-devices/labelling-an...
RegDesk Submission Builder · Confidential Page 39 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 40

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-145 P2 Australia · 6/22/2026 · Notification Getting started with UDI
Regulated-party impactTGA getting started with UDI guidance.
SB impactUpdate Australia UDI onboarding instructions.
Impact categoryInstructions/reference update
Affected pathwayUDI
Affected elementsUDI wizard onboarding/help text
Required actionCompare
Enforcement dateN/A
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.tga.gov.au/products/medical-devices/labelling-an...
SB-2026-159 P2 Bolivia · 6/25/2026 · Circular CIRCULAR-22-2026
Regulated-party impactRegulatory update requiring manual review.
SB impactManual review required to determine SB impact.
Impact categoryManual technical review
Affected pathwayNew registration
Affected elementsTo be determined
Required actionEscalate
Enforcement date6/25/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.agemed.gob.bo/img/matinf/CIRCULAR-22-2026_1.jpg
SB-2026-006 Watchlist China · 5/6/2026 · Draft for Comment NMPA Seeks Public Comments on Three Medical Device Registration Review Guidelines
Regulated-party impactChina NMPA draft registration review guidelines for public comment.
SB impactMonitor — no wizard change until final publication.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsChina wizard, product-specific technical review sections
Required actionMonitor
Enforcement date5/6/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/xwdt/zxyw/20260506085647159.html
SB-2026-054 Watchlist Kazakhstan · 5/19/2026 · Draft Resolution of the Government of the Republic of Kazakhstan "On the draft Law of the Republ
Regulated-party impactKazakhstan draft law amendment.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsKazakhstan wizard
Required actionMonitor
Enforcement date6/4/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://legalacts.egov.kz/npa/view?id=15829836
RegDesk Submission Builder · Confidential Page 40 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 41

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-055 Watchlist Kazakhstan · 5/19/2026 · Draft On Amendments to the Order of the Minister of Health of the Republic of Kazakhstan dated S
Regulated-party impactKazakhstan draft amendment to Ministry of Health order on medical devices.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsKazakhstan wizard
Required actionMonitor
Enforcement date6/4/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://legalacts.egov.kz/npa/view?id=15829812
SB-2026-056 Watchlist China · 5/12/2026 · Draft for Comment China Seeks Public Comment on Draft Registration Review Guidance for Anastomosis Reinforce
Regulated-party impactChina NMPA draft guidance for anastomosis devices.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsProduct-specific technical sections
Required actionMonitor
Enforcement date5/12/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/flfg/zdyz/zqyjg/20260512172630174.ht...
SB-2026-057 Watchlist China · 5/11/2026 · Draft for Comment China Seeks Public Comment on Draft Registration Review Guidance for Four Medical Device C
Regulated-party impactChina NMPA draft guidance for four device categories.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsProduct-specific sections
Required actionMonitor
Enforcement date5/11/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/flfg/zdyz/zqyjg/20260511173904118.ht...
SB-2026-058 Watchlist China · 5/6/2026 · Draft for Comment China Releases Draft Guidance for Public Comment on Three Medical Device Registration Revi
Regulated-party impactChina NMPA draft guidance for three device categories.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsProduct-specific sections
Required actionMonitor
Enforcement date5/6/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/flfg/zdyz/zqyjg/20260506085647159.ht...
RegDesk Submission Builder · Confidential Page 41 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 42

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-064 Watchlist Kazakhstan · 5/22/2026 · Draft On amendments and additions to the joint order of the Minister of Artificial Intelligence
Regulated-party impactDraft regulation or guidance open for consultation.
SB impactNo wizard change until final publication.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsN/A
Required actionMonitor
Enforcement date5/27/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://legalacts.egov.kz/npa/view?id=15833365
SB-2026-103 Watchlist Nicaragua · 6/8/2026 · Regulation Public Consultation 175 - (NTON) 24001
Regulated-party impactNicaragua draft technical standard for public consultation.
SB impactMonitor — no wizard change until final publication.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsTechnical standard references
Required actionMonitor
Enforcement date6/8/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.minsa.gob.ni/sites/default/files/publicaciones/C...
SB-2026-110 Watchlist China · 6/3/2026 · Draft for Comment China NMPA Seeks Public Input on Four Draft Medical Device Registration Review Guidelines
Regulated-party impactChina NMPA draft for four device categories.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsProduct-specific sections
Required actionMonitor
Enforcement date6/3/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/flfg/zdyz/zqyjg/20260603133519169.ht...
SB-2026-111 Watchlist China · 6/10/2026 · Draft for Comment China NMPA Opens Public Consultation on Draft Registration Review Guidelines for Infant Ra
Regulated-party impactChina NMPA draft review guidelines.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsProduct-specific sections
Required actionMonitor
Enforcement date6/10/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.cmde.org.cn/flfg/zdyz/zqyjg/20260610090641163.ht...
RegDesk Submission Builder · Confidential Page 42 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 43

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-114 Watchlist Kazakhstan · 6/10/2026 · Draft Order On amendments to the order of the Minister of Health of the Republic of Kazakhstan dated F
Regulated-party impactKazakhstan draft amendment to Ministry of Health order on medical devices.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsKazakhstan wizard
Required actionMonitor
Enforcement date6/25/2026
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://legalacts.egov.kz/npa/view?id=15846787
SB-2026-119 Watchlist Korea · 6/12/2026 · Draft Medical Device Manufacturing and Quality Control Standards
Regulated-party impactKorea MFDS draft QMS standards for device manufacturing.
SB impactMonitor — no wizard change until final publication.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsQMS evidence section
Required actionMonitor
Enforcement dateTBD
Confidence · ValidationMedium · Pending human validation
Official sourcehttps://www.mfds.go.kr/brd/m_209/view.do?seq=44254&srchFr=&s...
SB-2026-148 Watchlist Brazil · 6/23/2026 · Circular ANVISA Opens Public Call for Proposals to Improve Technovigilance Rules in Brazil.
Regulated-party impactANVISA consultation on improving technovigilance rules.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayPost-market/vigilance
Affected elementsPMS/vigilance wizard references
Required actionMonitor
Enforcement date6/23/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/202...
SB-2026-150 Watchlist Kyrgyzstan · 6/25/2026 · Draft Government's Decree
Regulated-party impactKyrgyzstan draft government decree.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsKyrgyzstan wizard
Required actionMonitor
Enforcement date7/17/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://koomtalkuu.gov.kg/ru/view-npa/6316
RegDesk Submission Builder · Confidential Page 43 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Alert Detail — Page 44

In-Scope MD/IVD/Combination Device Alerts
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
SB-2026-153 Watchlist China · 6/17/2026 · Draft for Comment China's NMPA Invites Industry Participation in Drafting Registration Review Guidelines for
Regulated-party impactChina NMPA invitation to participate in drafting guidance.
SB impactMonitor — no wizard change until final.
Impact categoryWatchlist—draft or unverified
Affected pathwayNew registration
Affected elementsProduct-specific sections
Required actionMonitor
Enforcement date6/17/2026
Confidence · ValidationLow · Pending human validation
Official sourcehttps://www.cmde.org.cn/xwdt/zxyw/20260617133619179.html
SB-2026-104 No SB action Lebanon · 6/9/2026 · Circular Circular No. 22 Regarding the Entry of Import Invoices for Non-Implanted Medical Devices o
Regulated-party impactLebanon import invoice entry requirement for non-implanted devices — administrative logistics.
SB impactNo SB action — administrative import invoice requirement, not a registration dossier change.
Impact categoryNo SB impact
Affected pathwayN/A
Affected elementsN/A
Required actionClose
Enforcement date8/9/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.moph.gov.lb/files/laws/files/Tamim_22_2026.pdf
SB-2026-113 No SB action Singapore · 6/11/2026 · Notification Mean Applicant Screening Response Time Audiences
Regulated-party impactSingapore HSA performance metrics publication.
SB impactNo SB action — administrative performance data, no regulatory delta.
Impact categoryNo SB impact
Affected pathwayN/A
Affected elementsN/A
Required actionClose
Enforcement date6/11/2026
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://www.hsa.gov.sg/announcements/mean-applicant-screenin...
SB-2026-149 No SB action Denmark · 6/18/2026 · Notification Fees for Clinical Trials of Medical Devices
Regulated-party impactDenmark fee schedule for clinical trials.
SB impactNo SB action — administrative fee schedule.
Impact categoryNo SB impact
Affected pathwayN/A
Affected elementsN/A
Required actionClose
Enforcement date—
Confidence · ValidationHigh · Pending human validation
Official sourcehttps://laegemiddelstyrelsen.dk/da/udstyr/klinisk-afproevnin...
RegDesk Submission Builder · Confidential Page 44 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026

Annex — Excluded Alerts

44 Alerts Excluded (Pharma-only or Out of Scope)
Medical Devices · IVDs · Combination Devices | May–July 2026 | Pharma excluded
These alerts were reviewed and excluded because they relate to pharmaceutical-only regulations, administrative/fee matters, cybersecurity incidents, or other topics outside the MD/IVD Submission Builder scope.
Alert ID Market Published Alert Title Reason for Exclusion
SB-EX-001 Chile 5/7/2026 Exempt Resolution No. E1.199/2026 approves the services and fees of th Fee schedule — administrative only
SB-EX-002 Pakistan 5/10/2026 Implementation of Online System for Submission and Processing of Appel Pharma-only or out-of-scope: drug
SB-EX-003 Guyana 5/11/2026 The Guyana Electronic Single Window (GESW) for permits, licenses, and Pharma-only or out-of-scope: single window
SB-EX-004 Argentina 5/13/2026 ANMAT promotes Regional Regulatory Cooperation and Regulatory updates Pharma-only or out-of-scope: anmat promotes regional
SB-EX-005 Finland 5/18/2026 The NIS2 Operator Notification is made in Fimea's Electronic Services. Pharma-only or out-of-scope: nis2 operator
SB-EX-006 Algeria 5/19/2026 Note No. 44 to Pharmaceutical Establishment Requirement for Tax Cleara Pharma-only or out-of-scope: pharmaceutical
SB-EX-007 Argentina 5/19/2026 ANMAT updates fees and reduces costs for 75% of importers of medicines Pharma-only or out-of-scope: medicine
SB-EX-008 Turkey 5/20/2026 Attention of Clinical Trial Parties Clinical trial administrative notice — pharma focus, no SB registration impact
SB-EX-009 Brazil 5/19/2026 ANVISA Launches DUIMP Queue Dashboard and Issues Guidance on Filing Co Pharma-only or out-of-scope: duimp queue
SB-EX-010 Turkey 5/20/2026 Attention of Clinical Trial Parties Clinical trial administrative notice — pharma focus, no SB registration impact
SB-EX-011 Italy 5/20/2026 Injectable Fillers: Clarifications on Distribution and Sales Methods Pharma/cosmetic distribution clarification — out of scope
SB-EX-012 Brazil 5/21/2026 Importation No. 048/2026 Import circular — administrative logistics, no dossier impact
SB-EX-013 Egypt 5/24/2026 Progress Follow-Up Report Template Clinical Trial of an Investigationa Pharma-only or out-of-scope: progress follow-up report template clinical trial of an investigational
SB-EX-014 Algeria 5/24/2026 Note No. 45 to Pharmaceutical Establishments on Submission of Tax Clea Tax clearance administrative requirement — no dossier impact
SB-EX-015 Ecuador 5/22/2026 Organic Law for Strengthening Cibersecurity Pharma-only or out-of-scope: cibersecurity
SB-EX-016 Chile 5/25/2026 ISP and CORFO Launch Strategic Project to Strengthen Medical Device Re Strategic investment announcement — no regulatory delta
SB-EX-017 Sweden 5/26/2026 The Swedish Medicines Agency Strengthens Preparedness – Surveys the Me General preparedness survey — no immediate regulatory delta
SB-EX-018 Sweden 5/26/2026 Registration of Invoicing Details for Economic Operators Registered in Administrative invoicing — no registration dossier impact
SB-EX-019 India 5/26/2026 Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devic Sampling guidance for drugs/cosmetics — pharma-focused
SB-EX-020 Denmark 5/28/2026 Registration Fee Pharma-only or out-of-scope: medicine
SB-EX-021 Colombia 5/28/2026 Invima Hosts a Conference on Healthcare Technologies from a Regulatory General conference announcement — no regulatory delta
SB-EX-022 Tanzania 5/31/2026 Explanation of the Challenges of the New Joint Load Relief System (TAN Customs logistics system — not MD registration scope
SB-EX-023 Denmark 5/28/2026 Annual Fee Pharma-only or out-of-scope: medicine
SB-EX-024 United States 6/2/2026 Drug and Device Manufacturer Communications With Payors, Formulary Com Drug-device communication guidance (mainly pharma payors) — out of scope
SB-EX-025 Germany 5/28/2026 Instructions for those Required to Report Address Ads Pharma-only or out-of-scope: address ads
SB-EX-026 Australia 6/3/2026 Annual charge waiver guidelines - How to apply for an annual charge wa Pharma-only or out-of-scope: annual charge waiver
SB-EX-027 Algeria 5/31/2026 Regulatory Inspections Guideline Pharma-only or out-of-scope: pharmaceutical
SB-EX-028 Bolivia 6/8/2026 Cyber Attack at AGEMED Systems Cybersecurity incident — no registration impact
SB-EX-029 Qatar 6/9/2026 Customs Union Authority Launches “Taysir” System to Address Trade Obst Pharma-only or out-of-scope: customs union
SB-EX-030 Botswana 6/10/2026 Notice of Implementation of a Combined Screening and Evaluation Proces Pharma-only or out-of-scope: medicine
SB-EX-031 Latvia 6/9/2026 The Government Supports the Consolidation of Supervision of the Pharma Pharma-only or out-of-scope: pharmaceutical
SB-EX-032 South Africa 6/10/2026 Guideline on Minimum Requirements for Inspecting Group III and Group I Hazardous substances inspection — not MD registration scope
SB-EX-033 South Africa 6/11/2026 Application for Authority for the Temporary Use, Possession and Transp Pharma-only or out-of-scope: temporary use, possession and transport of equ
SB-EX-034 Algeria 6/11/2026 Note to Pharmaceutical Institutions Pharma-only or out-of-scope: pharmaceutical
SB-EX-035 Lithuania 6/10/2026 Information Regarding a Cyber Incident Pharma-only or out-of-scope: cyber incident
SB-EX-036 Lithuania 6/10/2026 VASPVT Informs About the Controlled Cyber Incident in the Information Pharma-only or out-of-scope: cyber incident
SB-EX-037 Norway 6/12/2026 Medical Device Supervision Shows Challenges with Cosmetic Clinics and Market surveillance report — no dossier change required
SB-EX-038 United States 6/16/2026 TESTING ISSUES Test/sandbox entry — not a real alert
SB-EX-039 Australia 6/18/2026 TGA Releases New Guidance on Advertising Restrictions for Prescription Pharma advertising — out of scope
SB-EX-040 South Africa 6/15/2026 Guideline on Minimum Requirements for Inspecting Group III and Group I Hazardous substances inspection — not MD registration scope
SB-EX-041 Costa Rica 6/18/2026 Digital systems will be temporarily out of service Pharma-only or out-of-scope: digital systems
SB-EX-042 Bolivia 6/22/2026 AGEMED/CE/021/2026 General administrative circular — insufficient data
SB-EX-043 Bolivia 6/22/2026 MSyD/AGEMED/CR/19/2026 General administrative circular — insufficient data
SB-EX-044 Kuwait 6/13/2026 Electronic Invoice Release Platform Companies` User Manual Pharma-only or out-of-scope: pharmaceutical
RegDesk Submission Builder · Confidential Page 45 Assessment date: July 29, 2026 · Data cut-off: July 29, 2026