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
Important: MRA coverage for medical devices is more limited than in other regulated sectors. Bilateral and multilateral recognition agreements with MFDS may not cover all device types or all phases of the approval pathway (e.g., foreign GMP recognition may be accepted for manufacturing but clinical data acceptance may require additional Korean bridging studies). Always verify current status with MFDS or a qualified Korean regulatory consultant before finalizing a multi-market strategy.
Related pages
"(Vietnam, Thailand, Philippines, Indonesia have individual bilateral MoUs with MFDS; agreement scope and enforcement status vary. Confirm applicability with MFDS before relying on MRA for regulatory strategy.)"