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Regulatory Blogs
Browse updates and insights on medical device regulations across multiple countries.
Showing posts from August, 2025
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MDA | Malaysia–China Regulatory Reliance Program Pilot for IVD Devices (Phase 1)
Verification Pathway
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EC | New Manufacturer Incident Report (MIR) Form 7.3.1 Published — Mandatory from November 2025
June 24, 2025
HSA | Highlights from May 2025: UDI Expansion, SaMD Change Pathway & Key Industry Workshops
June 20, 2025
NMPA | Expanded Scope and GMP Requirements for Domestic Production of Imported Medical Devices in China
June 27, 2025
MDA | Updated ASEAN Harmonized Lists for Risk Classification and Borderline Medical Device Products (2025)
June 29, 2025
MDA | 65% of Online Medical Device Ads in 2024 Involved Unregistered Products
June 24, 2025
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