South Korea · Ministry of Food and Drug Safety · Medical devices
Review target
5 working days
regulation
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
₩130,000
Annex 10, amended 2026-07-01
Many Class 2 devices that are substantially equivalent to devices already on the Korean market are certified by the national medical device safety information institute rather than approved by the MFDS. The technical documents are reviewed first, and the certification itself has a 5-day processing period. Class 2 devices the MFDS lists for certification that are equivalent to, or modified versions of, devices already permitted.
The official review target is 5 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The manufacturing or import certification (electronic filing) is ₩130,000 for Annex 10, amended 2026-07-01.
1. Technical document review; 2. Apply for certification; 3. Certification review (5 days); 4. Certificate issued.
Outcome: A certificate, valid for 5 years and renewable. Valid for 5 years.
Legal basis: Medical Devices Act, Articles 6, 6-4 and 15; Enforcement Rule of the Medical Devices Act, Articles 4 and 9
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 5 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Official processing period for the certification step, not an actual time. Technical document review comes first. | 5 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Manufacturing or import certification (electronic filing)Application · Annex 10, amended 2026-07-01 | ₩130,000 |
Other routes in South Korea: Drug-device combination products, Class 1 medical device notification, Medical device permit (Classes 2 to 4), Innovative medical device designation, Digital medical device permit or certification (including software), Digital medical device notification (Class 1). See all routes on the South Korea page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.