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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
FDA Guidance on Hemodialysis Blood Tubing Sets: Key 510(k) Changes for July 23, 2026
The FDA has issued its final guidance for 510(k) submissions for Hemodialysis Blood Tubing Sets, replacing a 40-year-old document. This episode break…
2 months, 1 week ago
UK MHRA AI Scribe Guidance: Clarifying Regulatory Status of AI Medical Scribes
The UK's MHRA issued guidance on July 29, 2026, clarifying that certain Ambient Voice Technology (AVT), or 'AI scribes,' are not regulated as medical…
2 months, 1 week ago
SFDA Used Medical Device Resale: New Warning and Compliance Rules in Saudi Arabia
This episode details the Saudi Food and Drug Authority's (SFDA) public warning issued on July 28, 2026, regarding the non-compliant resale, auction, …
2 months, 1 week ago
UK MHRA AI Scribe Regulation: New Guidance for Ambient Voice Technology
This episode breaks down the UK MHRA's new guidance issued on July 29, 2026, clarifying when Ambient Voice Technology (AVT), or 'AI Scribes,' are reg…
2 months, 1 week ago
China NMPA 2026 Guidelines: Navigating 57 New Medical Device Rules
On July 21, 2026, China's NMPA issued 57 new final guidelines for medical devices in a single day, creating a significant new compliance challenge fo…
2 months, 2 weeks ago
TGA AI Medical Device Regulation: Preparing for 2026-2027 Enforcement in Australia
Australia's Therapeutic Goods Administration (TGA) has issued new guidance clarifying when AI-enabled software is regulated as a medical device (SaMD…
2 months, 2 weeks ago
Malaysia MDA Product Classification: Mandatory Online Submissions by August 2026
Malaysia's Medical Device Authority (MDA) is mandating fully online submissions for all medical device product classification applications starting A…
2 months, 2 weeks ago
FDA's MDUFA VI Draft Commitment Letter: Key Proposals and the August 7 Comment Deadline
This episode details the US FDA's newly released draft commitment letter for the sixth Medical Device User Fee Act (MDUFA VI), which will govern fisc…
2 months, 2 weeks ago
South Korea MFDS Proposal for Digital Medical Device Testing: What Manufacturers Need to Know
South Korea's Ministry of Food and Drug Safety (MFDS) has released Legislative Notice No. 2026-341, a proposal to amend the rules for medical device …
2 months, 2 weeks ago