Bangladesh — Gap Analysis Report

Definition

Bangladesh classifies medical devices into four risk classes (A, B, C, D) using a risk-based approach aligned with the IMDRF/ASEAN framework. Class A is lowest risk and Class D is highest risk. Classification is based on intended use, duration of contact, degree of invasiveness, and whether the device delivers energy or incorporates a substance.

Legal Basis

Classification Criteria

Classification Rules Summary (Schedule I)

The classification rules in Schedule I of the Medical Device Rules 2022 include:

• Rule 1 — Non-invasive devices: Generally Class A unless they interact with injured skin, contact blood/tissue fluids, or modify fluid compositions (Class B/C).
• Rule 2 — Invasive devices: Body orifice contact: Class A (short-term use), Class B (long-term), Class C/D (surgically invasive or implantable).
• Rule 3 — Surgically invasive devices: Short-term Class B; long-term implantable devices Class C or D.
• Rule 4 — Active devices: Active therapeutic devices Class B; active devices delivering energy in potentially hazardous manner Class C; active implantable devices Class D.
• Rule 5 — Special rules: Devices incorporating a medicinal substance, devices using human or animal tissues, devices for contraception or sterilization upgraded to Class C or D.
• Rule 6 — IVD devices: Class D (high-risk: HIV, blood grouping); Class C (self-testing, companion diagnostics); Class B (general lab use); Class A (general purpose lab instruments).

Additional Information

Where a device falls into multiple classes, the higher class applies. DGDA may reclassify a device based on new safety information. Combination products (device + drug) are regulated based on the primary mode of action. The classification list is periodically updated by DGDA gazette notification.

Definition

Obligations under the Medical Device Rules 2022 cover the full product lifecycle for manufacturers, importers, distributors, and authorized representatives. Key obligations include device registration, quality management, labeling, post-market surveillance, adverse event reporting, and appointment of a local authorized representative (AR) for foreign manufacturers.

Legal Basis

Key Obligations by Actor

Registration Requirements

• Class A: Simplified notification / listing with DGDA; basic technical documentation
• Class B: Full registration application; technical file; labeling review
• Class C: Full registration; ISO 13485 certificate; clinical evidence; QMS audit possible
• Class D: Full registration; pre-market approval; clinical data; third-party certification (FDA/CE/TGA accepted as supporting evidence); on-site inspection possible

Registration validity: typically 5 years, renewable before expiry.

Post-Market Obligations

• Post-market surveillance plan required for Class C and D devices
• Periodic Safety Update Reports (PSURs) for high-risk devices
• Adverse event reporting: serious incidents within 30 days; imminent hazards within 48 hours
• Field safety corrective actions (FSCA) must be reported to DGDA
• Recall procedures: DGDA-directed or voluntary; documented within MDR 2022 Rules 26–28

Definition

Bangladesh does not operate a European-style Notified Body (NB) system. The Directorate General of Drug Administration (DGDA) serves as the sole competent authority responsible for market authorization, conformity assessment, inspection, and regulatory oversight of medical devices. There is no separate third-party conformity assessment body formally designated as a "Notified Body" under Bangladeshi law.

Legal Basis

Competent Authority: DGDA

• Full name: Directorate General of Drug Administration
• Ministry: Ministry of Health and Family Welfare
• Address: 32 Manik Mia Avenue, Dhaka 1215, Bangladesh
• Website: www.dgda.gov.bd
• Role: Market authorization; GMP/QMS inspections; vigilance; import licensing; post-market surveillance

Third-Party Testing and Recognition

For Class C and D devices, DGDA may accept conformity certificates from recognized international bodies as supporting evidence:

• US FDA 510(k) clearance or PMA approval
• EU CE marking under EU MDR 2017/745 or EU IVDR 2017/746
• Australian TGA registration
• Japanese PMDA approval

Such certificates do not replace DGDA registration but may expedite the technical review process. Testing may be required at Bangladesh Standards and Testing Institution (BSTI) or BAB-accredited laboratories for specific product types.

Gap Note

Definition

Bangladesh does not have a dedicated regulation specifically governing batteries in medical devices. Battery safety requirements are addressed indirectly through the general safety and performance requirements of the Medical Device Rules 2022, applicable international standards referenced by DGDA, and transportation regulations (UN 38.3 for lithium batteries).

Legal Basis

Key Requirements

• Medical devices with integral or rechargeable batteries must comply with the essential safety and performance principles under Rule 11 of the Medical Device Rules 2022
• Devices must be designed to minimize risks of overheating, fire, explosion, or electrical hazards associated with batteries
• Battery type, voltage, and replacement instructions must be included on the label or in the instructions for use (IFU)
• Lithium batteries (rechargeable and non-rechargeable) must pass UN 38.3 testing for air transport
• IEC 62133 compliance is expected for rechargeable lithium-ion and nickel-metal hydride cells used in portable medical devices
• Battery disposal instructions should be included in the IFU in accordance with applicable waste management guidance

Gap Note

Definition

The shelf life of a medical device is the period during which a device, when stored under specified conditions, maintains its intended performance and safety characteristics. Bangladesh requires manufacturers to determine, validate, and declare the shelf life of their devices, which must appear on the product label and packaging.

Legal Basis

Labeling Requirements (Schedule III)

The following shelf-life-related information is mandatory on the label of a medical device marketed in Bangladesh:

• Expiry date (or "use by" date): must be expressed as DD/MM/YYYY or at minimum MM/YYYY
• Date of manufacture: required on the primary label
• Storage conditions (e.g., "Store below 25°C, away from direct sunlight")
• For sterile devices: sterile barrier system shelf life must be validated and stated
• Single-use designation with prohibition on reuse where applicable

Shelf-Life Validation

• Manufacturers must conduct real-time and/or accelerated aging studies to validate the claimed shelf life
• Studies must be documented in the technical dossier submitted to DGDA
• For sterile devices: sterile barrier integrity testing per ISO 11607-1 is required
• For implantable devices (Class D): extended shelf-life validation (typically up to 5–10 years) with documented rationale
• Shelf-life claims must be supported by stability data; DGDA may request this during technical review

Definition

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a European Union regulation (EC No 1907/2006). Bangladesh is not a member of the EU and has no equivalent national legislation to REACH. Therefore, EU REACH obligations (Substances of Very High Concern — SVHC, authorization, restriction) do not apply to devices placed solely on the Bangladeshi market.

Legal Basis

Status in Bangladesh

• Bangladesh has no national chemical registration or REACH-equivalent regulation
• The Bangladesh Environment Conservation Act 1995 provides general hazardous substance controls but does not impose SVHC identification or restriction requirements comparable to REACH
• Manufacturers exporting devices to both Bangladesh and the EU must comply with EU REACH for the EU market; REACH compliance is not a condition of DGDA registration
• Some multinational manufacturers voluntarily maintain REACH-compliant supply chains, but this is not a legal requirement for the Bangladesh market

Practical Guidance

Definition

RoHS (Restriction of Hazardous Substances) Directive 2011/65/EU restricts the use of specific hazardous materials (lead, mercury, cadmium, hexavalent chromium, PBBs, PBDEs, and four phthalates) in electrical and electronic equipment, including medical devices. Bangladesh has no national equivalent to RoHS and does not require RoHS compliance for devices placed on the Bangladesh market.

Legal Basis

Status in Bangladesh

• No RoHS-equivalent national regulation exists in Bangladesh as of 2025
• Electrical and electronic medical devices are regulated under the Medical Device Rules 2022 for safety and performance, but specific hazardous substance restrictions comparable to RoHS are not imposed
• Bangladesh has not enacted an E-waste / WEEE law that includes RoHS-style substance restrictions
• Manufacturers who comply with RoHS for EU exports may note compliance on technical documentation, but this is voluntary for the Bangladesh market

Practical Guidance

Definition

Change control requirements govern how post-approval changes to a registered medical device must be managed and communicated to DGDA. Changes that affect the safety, performance, or identity of a device may require a variation application (Type I or Type II) to be submitted to DGDA before implementation.

Legal Basis

Types of Changes and Requirements

Internal QMS Change Control

Under ISO 13485:2016 (mandatory for Class C and D), manufacturers must maintain a documented change control procedure covering:

• Risk assessment of proposed changes
• Determination of regulatory impact (reportable vs. non-reportable)
• Verification and validation of changes
• Update of design history file and technical documentation
• Communication to DGDA where required under Rule 25

Definition

Over-the-Counter (OTC) medical devices are devices that may be purchased and used without a prescription or medical supervision. In Bangladesh, the distinction between prescription and OTC devices is based on device classification and intended use. Generally, Class A and low-risk Class B devices may be sold OTC, while Class C and D devices typically require healthcare professional involvement.

Legal Basis

OTC Eligibility

OTC Labeling Requirements

• Instructions for use (IFU) must be in both English and Bengali for OTC devices sold to end consumers
• Adequate safety warnings and contraindications must be clearly stated
• Pictograms / symbols may supplement text but cannot replace Bengali-language instructions
• For self-test IVDs: step-by-step instructions in Bengali are mandatory
• Consumer-facing labels must include: device name, intended use, manufacturer, expiry date, storage conditions, and batch/lot number

Gap Note

Definition

Export certificates (also called Free Sale Certificates or Certificates of Free Sale) are official DGDA documents confirming that a medical device is legally registered and marketed in Bangladesh. They are issued to Bangladeshi manufacturers or importers for the purpose of exporting devices to foreign markets that require proof of home-country approval.

Legal Basis

Types of Export Certificates

Application Requirements

• Application to DGDA with proof of current device registration
• Fees payable as per DGDA fee schedule
• Certificate issued per product per destination country (or multi-country)
• Validity: typically 1–2 years; renewable
• Apostille / legalization available for countries requiring official notarization
• DGDA certificates are recognized under the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (applicable by analogy to medical devices)

Definition

Transportation and storage requirements for medical devices in Bangladesh ensure that devices maintain their safety, integrity, and performance characteristics throughout the supply chain. Requirements are set through labeling obligations in the Medical Device Rules 2022, with additional guidance from international standards and DGDA guidance.

Legal Basis

Storage Labeling Requirements (Schedule III)

• Temperature range: e.g., "Store between 2°C and 8°C" for cold-chain devices
• Humidity conditions: e.g., "Store in a dry place, relative humidity ≤ 60%"
• Light protection: e.g., "Keep away from direct sunlight"
• Handling precautions: e.g., "Fragile — Handle with care"; "Keep upright"
• Stacking/compression limits where applicable

Cold Chain Requirements

• Temperature-sensitive devices (e.g., certain IVDs, biologically derived devices) require validated cold-chain transport from manufacturer to end user
• Cold-chain validation studies should be included in the technical dossier
• Distribution centers and importers must maintain cold-chain facilities verified by DGDA inspection for Class C/D cold-chain devices
• Temperature excursion protocols must be documented and available to DGDA on request

Gap Note

Definition

Waste management requirements for medical devices in Bangladesh address the disposal of bio-medical waste generated by healthcare facilities and the handling of used/end-of-life medical devices, particularly those that are sharps, single-use, or contain hazardous materials. Bangladesh does not have a WEEE (Waste Electrical and Electronic Equipment) specific framework for medical devices.

Legal Basis

Medical Waste Management Rules 2008 — Key Categories

Manufacturer Obligations

• Single-use devices: must be clearly labeled "Single Use Only" with a prohibition symbol (DO NOT REUSE) per Schedule III
• IFU must include disposal instructions appropriate for the device type and materials
• For devices containing mercury, lead, cadmium, or radioactive components: special disposal instructions required
• Importers and distributors are responsible for ensuring customers receive adequate disposal guidance

Gap Note

Definition

AI-enabled medical devices (AI/ML-based Software as a Medical Device — SaMD) are medical devices that use artificial intelligence or machine learning algorithms to diagnose, monitor, treat, or predict medical conditions. As of 2025, Bangladesh does not have a specific regulatory framework for AI medical devices. AI-based medical devices are regulated under the general Medical Device Rules 2022 framework, classified by risk and intended use.

Legal Basis

Current Regulatory Status

• No AI-specific regulation: DGDA has not published AI/ML-specific guidance for medical devices as of 2025
• Classification: AI-based SaMD is classified under the general classification rules based on intended use and risk. An AI diagnostic tool for detecting cancer would likely be Class C or D; a general wellness app would be Class A (if regulated at all)
• Software lifecycle: IEC 62304 compliance is expected in the technical dossier for software-based devices
• Clinical evidence: AI/ML-based devices require clinical performance evaluation data demonstrating algorithm accuracy, sensitivity, specificity, and safety
• Continuous learning: AI devices that update algorithms post-market (adaptive AI) would likely require a variation application under Rule 25 for each significant algorithm update affecting performance

Recommended International Standards for AI SaMD in Bangladesh

Gap Note