Multi-Market Submission Strategy
When submitting to multiple regulators globally — including MFDS — a well-planned strategy can significantly reduce duplication of effort.
Leveraging IMDRF alignment
MFDS has aligned its STED format with the IMDRF STED. A single well-prepared STED can form the basis for submissions to MFDS, FDA, TGA, and Health Canada with jurisdiction-specific supplements:
| STED section | Global | Korea-specific addition |
|---|---|---|
| Device description | Common | Korean product code; Korean product name |
| Risk management | ISO 14971 — common | No major additions |
| Clinical data | Common | Korean clinical data if required by MFDS |
| Labelling | Market-specific | Korean-language label required |
| Testing | IEC/ISO — common | Test reports from MFDS-recognised labs |
Sequence recommendations
For most manufacturers, the recommended submission sequence is:
- First — FDA 510(k) or PMA / EU CE marking (largest markets; most developed guidance)
- Second — Korea, Australia, Canada (use FDA/CE data as base)
- Third — Singapore, Southeast Asian markets
Korean MFDS generally accepts FDA or CE clinical data with appropriate Korean supplement.
Korea-specific items to plan for
- KGMP / foreign GMP certificate — obtain early; can be on the critical path
- Korean-language labelling — requires translation lead time
- MFDS-recognised lab testing — if not already done using IEC/KS standards