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MFDS Review Process and Timelines

Review lifecycle​

1. Submitted via eSubmission portal
2. Completeness check (10–15 business days)
   └─ Incomplete → 보완요청 (request for additional information)
3. Technical review — STED, clinical data, labelling
4. GMP review — confirm valid KGMP / foreign GMP certificate
5. Decision
   ├─ 허가 (Approved) — 품목허가증 issued
   └─ 불허 (Rejected) — reasons provided; right of appeal

Clock stops on 보완요청​

When MFDS requests additional information (보완요청), the review clock stops until response is received. Applicants typically have 60–90 days to respond.

Post-approval certificate​

The 품목허가증 (Product Permit Certificate) must be maintained and updated whenever changes occur to the product, labelling, or manufacturing site.

Relevant legislation​

  • Medical Devices Act, Articles 6, 8