IMDRF — MFDS Membership and Alignment
Korea is a founding member of IMDRF (International Medical Device Regulators Forum) and MFDS actively participates in IMDRF working groups.
MFDS participation
- MFDS has served as Chair and Co-Chair of IMDRF working groups on SaMD, UDI, and adverse event terminology
- MFDS regulatory staff actively participate in drafting IMDRF N-documents
- Korea hosted IMDRF annual meetings
IMDRF guidance adopted by MFDS
| IMDRF document | Topic | Korean implementation |
|---|---|---|
| N10/N12/N23 | SaMD framework | MFDS SaMD classification guidance |
| STED templates | Technical documentation | MFDS STED format |
| UDI guidance | Unique device identification | UDI-K system |
| Adverse event reporting terminology | PMS | MFDS adverse event reporting |
Benefits of IMDRF alignment for manufacturers
Manufacturers with submissions to FDA, TGA, or EU bodies can often leverage their existing IMDRF-aligned documentation (STED, clinical evaluation, adverse event reporting) for Korean submissions, reducing duplication of effort and accelerating review timelines.