IMDRF Guidance Adopted by MFDS
Korea is an active [Note: Founding members were US FDA, Health Canada, Japan PMDA, Australia TGA, and Brazil ANVISA; Korea joined as a participant member in the early years] member of the International Medical Device Regulators Forum (IMDRF) and MFDS has adopted or aligned its guidance with numerous IMDRF documents.
Key IMDRF alignmentsโ
| IMDRF document | Topic | MFDS alignment |
|---|---|---|
| N10 / N12 / N23 | SaMD framework | MFDS SaMD guidance aligns with IMDRF N-documents |
| STED templates | Technical documentation | MFDS STED format aligns with IMDRF STED |
| Adverse event terminology | Post-market reporting | MFDS reporting terminology aligned |
| GHTF Study Group documents | Pre-market, post-market, auditing | Referenced in MFDS notifications |
| UDI guidance | Unique device identification | UDI-K aligns with IMDRF UDI guidance |
IMDRF participationโ
MFDS actively participates in IMDRF working groups and has chaired or co-chaired selected working groups.