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Japan PMDA Generative AI: New Draft Criteria for Programmed Medical Devices
On September 18, 2026, Japan's PMDA published draft review criteria for programmed medical devices (SaMD) that use generative AI, such as LLMs. This …
1 week, 3 days ago
FDA Robotic Surgery Guidance: Key Changes for Premarket Submissions
The US FDA released a new draft guidance on September 24, 2026, outlining its expectations for premarket submissions of Robotically-Assisted Surgical…
1 week, 4 days ago
EU EUDAMED SSCP/SSP Upload: MDCG 2026-4 Mandates Manufacturer Responsibility by October 2026
This episode covers the significant procedural change announced in MDCG 2026-4, where medical device and IVD manufacturers will now be responsible fo…
1 week, 5 days ago
Brazil ANVISA Medical Device Vigilance: Public Call on SaMD and AI Rules
Brazil's ANVISA has opened Public Call No. 4/2026, seeking industry feedback on a major revision of its medical device post-market vigilance (Tecnovi…
1 week, 6 days ago
EU MDCG 2020-16 Rev 5: IVDR Classification for IVD Quality Control Materials
This episode details the September 9, 2026 update to the EU's MDCG 2020-16 guidance, Revision 5. We explain the crucial clarifications on classifying…
2 weeks ago
Brazil ANVISA High-Risk Device Registration: Navigating Public Consultation 1248
Brazil's ANVISA has released Public Consultation No. 1248, proposing a major overhaul of the registration process for Class III and IV high-risk medi…
2 weeks, 1 day ago
UK MHRA Health Bill Amendments: Future of Medical Device Licensing
The UK government tabled three amendments to the Health Bill on September 1, 2026, signaling a major overhaul of the MHRA's regulatory powers for med…
2 weeks, 2 days ago
FDA's New PMA Electronic Submission Template: Draft Guidance Explained
This episode details the US FDA's new draft guidance on an electronic submission template for Premarket Approval (PMA) applications, issued on Septem…
2 weeks, 3 days ago
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, 4 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…
2 weeks, 5 days ago