MD3/IVD3: A global snapshot – Non-EU regulatory updates for medical devices and IVDs
By Célia Cruz2025-11-18T10:00:00
Key points:
- The UK is actively developing its post-Brexit regulatory framework, with a focus on international reliance and a more pragmatic approach to conformity assessment for certain device classes
- Canada’s regulatory system, strongly influenced by its active role in the International Medical Device Regulators Forum (IMDRF), presents a mature and structured pathway for medical device (MD) approval, with the Medical Device Single Audit Program (MDSAP) as a cornerstone for manufacturers
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