Weekly Regulatory News

Malaysia's Medical Device Authority (MDA) and Japan's Ministry of Health, Labour and Welfare (MHLW) have signed a Memorandum of Cooperation (MoC) in Tokyo, marking a significant step toward regulatory alignment and closer collaboration between the two countries. The agreement lays the groundwork for more efficient medical device registration, enhanced information sharing, and improved post-market surveillance frameworks. Manufacturers operating in both markets could benefit from greater regulatory predictability and streamlined market access as the partnership develops.

The Swissmedic swissdamed fees 2026 update introduces mandatory medical device registration in Switzerland from 1 July 2026 under MedDO and IvDO. Devices must be registered in swissdamed and will be subject to annual fees based on UDI-DI counts, with a CHF 200 base fee and CHF 20 per additional device, capped at CHF 10,000 per manufacturer. The regulation aligns Swiss medical device registration with lifecycle-based compliance and introduces a transition period until 31 December 2026.

The U.S. FDA human factors guidance 2026 update revises requirements for human factors information in medical device marketing submissions, including 510(k), De Novo, and PMA pathways. It introduces new risk-based Human Factors Submission Categories 1–3, expands examples for modified devices, and clarifies expectations for usability validation. Sponsors must assess use-related risks, device complexity, and interface changes when determining submission requirements to ensure compliance with FDA usability engineering expectations.

Mexico has published NOM-137-SSA1-2025, a major overhaul of its medical device labeling standard that introduces stricter traceability requirements, expanded use of international symbols, and stronger sterility labeling expectations. Foreign manufacturers and importers will feel the greatest impact, with likely updates needed across labels, IFUs, and contra-labeling processes. With mandatory compliance kicking in on May 14, 2027, the roughly 360-day transition window makes now the right time to start your gap assessment.