Latest Regulatory Alerts
4 posts · Page 1 of 3HSA Approves AI-Enhanced Dengue Rapid Antigen Test Under New IVD Pathway
Singapore's Health Sciences Authority has granted product registration to ViralSense Diagnostics' AI-augmented dengue NS1 rapid antigen test, the first IVD cleared under HSA's revised Class C registration pathway which now accepts AI-assisted reader software as part of the device system.
Read more →MFDS Releases Cybersecurity Guidance for Internet-of-Medical-Things Devices
South Korea's Ministry of Food and Drug Safety has published binding cybersecurity guidance for Internet-of-Medical-Things devices, mandating Software Bill of Materials submissions and post-market vulnerability disclosure windows of no more than 30 days for critical-severity findings.
Read more →SFDA Confirms Phase 2 UDI Mandatory Implementation for Class B and C Devices
The Saudi Food and Drug Authority has confirmed that Phase 2 of its Unique Device Identification programme will become mandatory for Class B and Class C medical devices effective 01 January 2027, following a six-month pilot period that enrolled over 340 manufacturers.
Read more →COFEPRIS Introduces Expedited De Novo Pathway for Novel Class III Medical Devices
Mexico's Federal Commission for Protection against Sanitary Risk has established a formal De Novo classification pathway for novel Class III medical devices lacking a valid predicate, cutting average review timelines from 18 months to a target of 90 working days for qualifying submissions.
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