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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​

Clock stops on 보충요청 When MFDS requests additional information (보충요청), the review clock stops until a complete response is received. Applicants are typically given 60–90 days to submit responses, though this period may be extended upon request. The review clock resumes upon receipt of the response.

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

Expected total review timeline

From initial submission to final decision, applicants should anticipate:

  • Completeness check: 10–15 business days
  • Technical review (if application complete): 30–90 business days depending on device complexity and grade
  • GMP verification: 5–15 business days (concurrent with technical review)
  • Any 보충요청 response period: 60–90 days (applicant response time; clock stopped)

Total time from submission to approval typically ranges from 60–180 calendar days for Grade I/II devices and 120–300 calendar days for Grade III/IV devices, assuming no major deficiencies.