ARTICLE SUMMARY:
In this week’s Pathways Picks: Malaysia and Singapore sign a regulatory reliance agreement; China drafts real-world data standards; a guide on stents from South Korea and one on AI/ML from South Africa; Chile bulks up device program with new funding; Canada launches new eSTAR submission pilot; researchers study recalls in FDA-cleared AI devices; and more from the US, Europe, and China.
Asia Picks
Malaysia-Singapore harmonization, and new policy docs from China and South Korea:
Malaysia-Singapore pact. The two countries signed a memorandum of understanding (MOU) including an agreement to launch a regulatory reliance pilot where devices authorized by one authority will benefit from a fast-tracked review from the other. Under the pact, a device registered with Singapore’s Health Sciences Authority (HSA) can access Malaysia’s “verification route,” which takes about 30 rather than the standard 60 days for review. Devices registered with Malaysia’s Medical Device Authority (MDA), meanwhile, can leverage HSA’s “abridged” review pathway, promising 30% shorter review times for Class B-D devices. The agreement is similar to one MDA inked last month with China’s National Medical Products Administration (NMPA).
