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FDA MDUFA VI Fees: Proposed Increases for Overseas Manufacturers
The US FDA is considering higher user fees for overseas medical device manufacturers under the proposed MDUFA VI agreement for fiscal years 2028-2032…
1 month, 4 weeks ago
India's Draft Drugs, Medical Devices and Cosmetics Bill 2026: Key Changes for Manufacturers
This episode covers India's draft Drugs, Medical Devices and Cosmetics Bill 2026, circulated for feedback on August 7, 2026. We discuss its proposal …
2 months ago
Health Canada MDEL Modernization: Preparing for Phase 2 Changes by December 2026
Health Canada is implementing Phase 2 of its Medical Device Establishment Licence (MDEL) modernization, with all changes coming into force on Decembe…
2 months ago
EU AI Act and Medical Devices: New Compliance Deadline of August 2, 2028
This episode covers the EU's postponement of the AI Act compliance deadline for high-risk AI medical devices to August 2, 2028. We discuss Regulation…
2 months ago
China NMPA's 57 New Medical Device Guidelines: Immediate Impacts for Manufacturers
On July 21, 2026, China's NMPA released 57 new medical device guidelines, creating immediate compliance challenges for manufacturers. This episode br…
2 months ago
FDA Human Factors Guidance 2026: Navigating New eSTAR Requirements
The US FDA has finalized its guidance on 'Content of Human Factors Information in Medical Device Marketing Submissions,' introducing a new risk-based…
2 months ago
ANVISA Chile ISP Cooperation: Preparing for Latin American Regulatory Convergence
This episode explores the technical exchange held between Brazil's ANVISA and Chile's ISP from July 6-10, 2026. We analyze the key topics discussed—i…
2 months ago
FDA Human Factors Guidance 2026: What 510(k) and PMA Teams Need to Know
This episode provides a detailed analysis of the U.S. FDA's final guidance on 'Content of Human Factors Information in Medical Device Marketing Submi…
2 months ago
FDA Non-Device Software Functions: Public Input Deadline for 2026 Report
The US FDA has issued a request for public input, due by August 13, 2026, on the risks and benefits of software functions excluded from the medical d…
2 months, 1 week ago
Mexico COFEPRIS Equivalence Pathway: New Guidance for Medical Device Registration
Mexico's COFEPRIS released new guidance in late July 2026 clarifying documentation requirements for its Equivalence and Abbreviated regulatory pathwa…
2 months, 1 week ago