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UK MHRA AI Medical Device Rules: What the New Lifecycle Framework Means for Manufacturers
The UK government has committed the MHRA to a new lifecycle-based regulatory framework for AI-enabled medical devices, moving away from one-time pre-…
12 hours ago
UK MHRA AI Medical Device Regulation: New Lifecycle Approach and AI Airlock Phase 3
The UK government has accepted all 44 recommendations for regulating AI in healthcare, marking a major policy shift for the MHRA. As of October 6, 20…
1 day, 12 hours ago
China NMPA's Revised GMP: What Manufacturers Must Do by the November 2026 Deadline
China's National Medical Products Administration (NMPA) is enforcing a revised Good Manufacturing Practice (GMP) for medical devices, with a complian…
2 days, 12 hours ago
Health Canada MDEL Amendments 2026: New Rules for Distributors and Importers
Health Canada's amended Medical Devices Regulations introduce major changes effective December 14, 2026. This episode breaks down the new MDEL exempt…
3 days, 12 hours ago
Indonesia Halal Certification: Class A Medical Device Deadline on October 17, 2026
Indonesia is enforcing mandatory Halal certification for medical devices, with the first deadline for low-risk Class A devices set for October 17, 20…
4 days, 12 hours ago
UK MHRA Wireless CTG Safety Alert: Post-Market Actions for Manufacturers
This episode examines the UK MHRA's Device Safety Information (DSI/2026/012), issued on September 29, 2026, which details critical safety risks for w…
5 days, 12 hours ago
Japan PMDA SaMD Guidance: 2026 Update and Submission Strategy
On September 18, 2026, Japan's PMDA released a major update to its guidance for Software as a Medical Device (SaMD). This episode breaks down the key…
6 days, 12 hours ago
UK MHRA Patient Hoist Safety Alert: Actions for NatPSA/2026/005/MHRA by September 2026
This episode details the UK MHRA's National Patient Safety Alert (NatPSA/2026/005/MHRA) on the risks of death and serious harm from falls involving p…
1 week ago
SFDA Medical Device Advertising Compliance: Responding to New Enforcement Actions
The Saudi Food and Drug Authority (SFDA) has taken enforcement action against a medical device company for non-compliant advertising, signaling a str…
1 week, 1 day ago
TGA CDSS Exemption Changes: Preparing for the November 1, 2026 Deadline
Australia's Therapeutic Goods Administration (TGA) has amended the exemption criteria for Clinical Decision Support Software (CDSS), with significant…
1 week, 2 days ago