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MFDS Korea Post-Market Study Exemption: Leveraging Overseas Data Under Notice 2026-63
This episode breaks down South Korea's Ministry of Food and Drug Safety (MFDS) Notice No. 2026-63, which details new evidence requirements for obtain…
2 weeks, 6 days ago
Health Canada Exceptional Importation: Navigating the Updated Forms for Medical Device Shortages
This episode covers Health Canada's September 2, 2026, update to the forms for exceptional importation and sale of medical devices. We discuss the ke…
3 weeks ago
China NMPA GMP Inspection Guidance: Preparing for the November 1, 2026 Deadline
China's NMPA has released new mandatory GMP Inspection Guidance Principles, effective November 1, 2026. This episode breaks down the critical changes…
3 weeks, 1 day ago
FDA Radiology AI Software 510(k) Exemption: Final Order Clarifies Pathways for CADe/CADx Devices
The US FDA's final order on September 17, 2026, clarifies the partial 510(k) premarket notification exemption for specific AI/ML-driven radiology sof…
3 weeks, 2 days ago
China NMPA BCI Standard: New Rules for AI-Powered Medical Devices
China's NMPA has released the world's first product standard for AI-powered Brain-Computer Interface (BCI) medical devices, effective September 1, 20…
3 weeks, 3 days ago
China NMPA Policy on Localizing Imported Medical Device Production
China's NMPA issued a notice on September 9, 2026, significantly streamlining the regulatory process for foreign manufacturers to localize the produc…
3 weeks, 4 days ago
Mexico COFEPRIS Authorized Third Parties: New 4-Year Validity and Operating Guidelines
Mexico's health regulator, COFEPRIS, has updated the operational guidelines for Authorized Third Parties (ATPs), effective September 3, 2026. This ep…
3 weeks, 5 days ago
SFDA AI Medical Software: Market Access in Saudi Arabia After First SaMD Approvals
The Saudi Food and Drug Authority (SFDA) has approved its first two locally developed AI-enabled Software as a Medical Device (SaMD) products, 'Denta…
3 weeks, 6 days ago
Australia TGA CDSS Exemption 2026: What SaMD Manufacturers Need to Know
Australia's Therapeutic Goods Administration (TGA) has amended the exemption criteria for Clinical Decision Support Software (CDSS), effective Novemb…
4 weeks ago
India CBIC Medical Device Import Checklist: New Customs Clearance Requirements
India's Central Board of Indirect Taxes and Customs (CBIC) has introduced a new standardized checklist for the import clearance of medical devices, e…
4 weeks, 1 day ago