IMDRF — FDA's Membership & Alignment
What is IMDRF?
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulatory authorities from around the world working to accelerate international medical device regulatory harmonisation and convergence. It was established in 2011 as the successor to the Global Harmonization Task Force (GHTF).
IMDRF members
Current IMDRF member regulators include:
- 🇺🇸 FDA (USA) — founding member and active participant
- 🇪🇺 European Commission / EUDAMED
- 🇦🇺 TGA (Australia)
- 🇨🇦 Health Canada
- 🇸🇬 HSA (Singapore)
- 🇯🇵 PMDA (Japan)
- 🇧🇷 ANVISA (Brazil)
- 🇷🇺 Roszdravnadzor (Russia)
- 🇨🇳 NMPA (China)
- 🇰🇷 MFDS (South Korea)
- 🇿🇦 SAHPRA (South Africa)
Key IMDRF guidance documents
IMDRF produces guidance documents that form the basis of regulatory harmonisation. FDA participates in developing these and often incorporates them into US guidance:
| IMDRF Document | US FDA Impact |
|---|---|
| SaMD: Key Definitions (N12) | FDA adopted the SaMD definition in its software guidance |
| SaMD: Risk Categorisation Framework (N23) | Informed FDA's risk-based approach to SaMD regulation |
| SaMD: Clinical Evaluation (N41) | Referenced in FDA's SaMD clinical evaluation guidance |
| UDI Guidance (N7, N48) | Informed FDA's 21 CFR Part 830 UDI rule |
| Auditing Practices (N22) | Used as reference for QMS audit practices |
| Adverse Event Terminology (N43) | Aligns MDR terminology across jurisdictions |
How IMDRF affects FDA submissions
While IMDRF documents are not binding regulations in the USA, FDA:
- Publishes guidance documents that reference and align with IMDRF positions
- Accepts evidence generated using IMDRF-aligned frameworks (e.g., SaMD clinical evaluation using the N41 framework)
- Participates actively in IMDRF working groups on cybersecurity, AI/ML, and post-market surveillance