IMDRF — Singapore's Membership and Alignment
What is IMDRF?
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world that works to harmonise regulatory requirements for medical devices globally. IMDRF is the successor body to the Global Harmonization Task Force (GHTF).
IMDRF members include: HSA (Singapore), TGA (Australia), Health Canada, FDA (USA), MHLW/PMDA (Japan), EC/EUDAMED (EU), NMPA (China), ANVISA (Brazil), and several others.
IMDRF website: imdrf.org
Singapore's participation
Singapore (through HSA) is a founding member of IMDRF and a current member of the IMDRF Management Committee. Singapore participates actively in IMDRF working groups and has co-authored several IMDRF guidance documents.
HSA's IMDRF page: hsa.gov.sg/medical-devices/international-collaboration-medical-devices/imdrf
Key IMDRF documents referenced in Singapore's framework
| IMDRF document | Relevance to Singapore |
|---|---|
| N10 — Unique Device Identification System | Referenced in HSA guidance on UDI |
| N12 — Software as a Medical Device (SaMD) framework | Basis for HSA's SaMD classification approach |
| N41 — SaMD clinical evaluation | Referenced in digital health guidance |
| N47 — Principles and Practices for Medical Device Cybersecurity | Basis for HSA's cybersecurity guidance |
| N56 — AI/ML-based SaMD | Emerging reference for AI medical device regulation |
| Adverse Event Reporting guidance | Informs HSA's AE reporting framework |