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Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.

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PMS RequirementsFebruary 18, 20261 min read

Global Post-Market Surveillance Requirements: Japan, Australia, China, Brazil, UK, Korea, India (2026)

Comprehensive guide to medical device PMS requirements across 7 jurisdictions — Japan (PMDA), Australia (TGA), China (NMPA), Brazil (ANVISA), UK (MHRA), South Korea (MFDS), and India (CDSCO). Includes reporting timelines, local representative requirements, and MDSAP harmonization.

Japan PMDAAustralia TGAChina NMPABrazil ANVISAUK MHRApost-market surveillanceIMDRF
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