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Brazil ANVISA Innovative Device Pilot Program 2026: A Guide for High-Risk MedTech
Brazil's ANVISA has opened a new pathway for innovative, high-risk medical devices. On August 5, 2026, the agency published Call Notice 5/2026, invit…
1 month, 2 weeks ago
SFDA Biocompatibility Requirements: Preparing Medical Device Submissions for Saudi Arabia
The Saudi Food and Drug Authority (SFDA) is increasing its focus on the biological evaluation of medical devices, highlighted by its upcoming worksho…
1 month, 2 weeks ago
FDA Discussion Paper on Generative AI in Medical Devices: Feedback Deadline and Key Considerations
This episode details the US FDA's discussion paper on regulating medical devices incorporating Generative Artificial Intelligence (GenAI), released o…
1 month, 3 weeks ago
FDA Proposed Rule on Class I Accessories: 2026 Changes for 510(k) Exemption
This episode covers the U.S. FDA's proposed rule from August 14, 2026, which aims to classify a specific list of medical device accessories as Class …
1 month, 3 weeks ago
Saudi Arabia SFDA Medical Device Advertising Rules: MDS-REQ 8 Compliance for Manufacturers
The Saudi Food and Drug Authority (SFDA) has implemented new mandatory requirements for medical device advertising, effective July 20, 2026. This epi…
1 month, 3 weeks ago
CMS RAPID Coverage Pathway: Breakthrough Device Reimbursement Changes
The U.S. Centers for Medicare & Medicaid Services (CMS) has introduced a major policy change with the new Regulatory Alignment for Predictable and Im…
1 month, 3 weeks ago
Australia TGA Suspends Corpuls Defibrillators: What It Means for Post-Market Compliance
On August 12, 2026, Australia's Therapeutic Goods Administration (TGA) suspended the supply of Corpuls 3 and 3T defibrillators. This episode breaks d…
1 month, 3 weeks ago
MHRA National Alert DSI/2026/007: Quarantining Devices Without UKCA or CE Marks
This episode examines the UK MHRA's national alert DSI/2026/007, issued on August 10, 2026, which mandates the quarantine of medical devices supplied…
1 month, 3 weeks ago
MHRA Non-Compliant Medical Devices: UK Quarantine Order and Supply Chain Lessons
The UK's MHRA issued a Device Safety Information alert (DSI/2026/007) on August 10, 2026, ordering an immediate quarantine of six types of medical de…
1 month, 3 weeks ago
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