MRA Agreements and Bilateral Recognition
Korea has entered into Mutual Recognition Agreements (MRAs) and bilateral arrangements with certain countries to reduce duplicative regulatory requirements.
Current MRA and recognition status
| Country / Region | Status |
|---|---|
| ASEAN countries | MFDS aligns with ASEAN AMDD framework; individual country MRAs vary |
| IMDRF members (general) | MFDS accepts clinical data from other IMDRF member jurisdictions |
| ISO 13485 (IAF MLA members) | MFDS recognises ISO 13485 certificates as evidence for foreign GMP |
Impact on manufacturers
Where a mutual recognition or harmonisation arrangement exists:
- GMP certificates from recognised countries/authorities may reduce or eliminate the need for MFDS overseas inspection
- Clinical data from recognised regulatory submissions (FDA, TGA, CE) may be directly usable for Korean applications
- Technical documentation aligned with IMDRF STED format is accepted
note
MRA coverage for medical devices is more limited than in other sectors. Verify current status with MFDS or a Korean regulatory consultant.