South Korea · Ministry of Food and Drug Safety · Medical devices
Review target
80 working days
regulation
Legal time limit
-
Not published
Steps
4
7 requirements
Application fee
₩98,430,000
Annex 10, amended 2026-07-01
Class 3 and Class 4 devices, and Class 2 devices that are not equivalent to devices already permitted, need a product permit from the MFDS. The agency reviews technical documents and, where needed, clinical data. Fully new devices pay a much higher fee and can be put under a post-market study for 4 to 7 years. Class 3 and 4 devices; Class 2 devices without an equivalent permitted device; devices combined with medicines.
The official review target is 80 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The permit for a new device, including technical document review (electronic filing) is ₩98,430,000 for Annex 10, amended 2026-07-01.
1. Technical document and clinical data review (70 days); 2. Permit application and review (80 days); 3. Answer requests for more data; 4. Permit issued.
Outcome: A product permit, valid for 5 years and renewable. A manufacturing or import business license is issued together with the first product. Valid for 5 years.
Legal basis: Medical Devices Act, Articles 6, 8, 15 and 49; Enforcement Rule of the Medical Devices Act, Articles 4, 5 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 150 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 periods, not actual review times. Periods over 5 days count working days (Saturdays and public holidays are not counted). Time the applicant spends answering requests is outside the period. | 80 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Permit for a new device, including technical document review (electronic filing)Application · Annex 10, amended 2026-07-01 | ₩98,430,000 |
| Permit with technical document and clinical data review, not a new device (electronic filing)Application · Annex 10, amended 2026-07-01 | ₩1,495,000 |
Other routes in South Korea: Drug-device combination products, Class 1 medical device notification, Class 2 medical device certification, 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 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.