Podcast Episodes
Back to Search
EU REP Symbol Transition: Compliance Guide for Medical Device Labeling by 2031
This episode details the formal transition from the 'EC REP' to the 'EU REP' symbol for European Authorized Representatives on medical device and IVD…
2 months, 4 weeks ago
Saudi Arabia SFDA Medical Device Bundling: Key Changes in Guidance MDS-G-028
Saudi Arabia's SFDA has released a new guidance document, MDS-G-028, effective May 3, 2026, which significantly changes the rules for bundling medica…
2 months, 4 weeks ago
Australia TGA UDI Requirements: High-Risk Device Compliance by July 1, 2026
Australia's Therapeutic Goods Administration (TGA) is implementing mandatory Unique Device Identification (UDI) requirements for high-risk medical de…
3 months ago
EU MDR Well-Established Technologies (WET) Exemption: New Rules for Class III and IIb Devices
The European Commission has significantly expanded the list of 'well-established technologies' (WET) under the EU Medical Devices Regulation (MDR) as…
3 months ago
China NMPA BCI Classification Guidance: A New Framework for Neurotech Devices
China's National Medical Products Administration (NMPA) has released its first-ever "Guiding Principles for the Classification of Brain-Computer Inte…
3 months ago
FDA MDUFA VI Reauthorization: What to Expect for FY 2028-2032
The US FDA has announced a public meeting on July 22, 2026, to discuss the proposed recommendations for the sixth reauthorization of the Medical Devi…
3 months ago
Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting
On July 1, 2026, Brazil's ANVISA mandated the use of its new e-Notivisa system for all medical device adverse event reporting, replacing the legacy N…
3 months ago
Brazil ANVISA Regulatory Reliance: IN 290/2024 Changes for Class III & IV Devices
Brazil's ANVISA has implemented a more flexible amendment process for its regulatory reliance pathway for high-risk medical devices under Normative I…
3 months ago
EU MDCG 2026-4: SSCP Upload to EUDAMED for Class III & Implantable Devices
This episode covers the EU's new MDCG 2026-4 guidance, which transfers the responsibility for uploading the Summary of Safety and Clinical Performanc…
3 months ago
China NMPA Innovative Device Approvals Accelerate: Market Access in 2026
China's NMPA is rapidly approving innovative medical devices, creating a major opportunity for global manufacturers. A new report reveals that 40 inn…
3 months, 1 week ago