South Korea · Ministry of Food and Drug Safety · Medical devices
Review target
5 working days
regulation
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
-
Most Class 1 medical devices, the lowest-risk group, only need a product notification. The notification goes to the national medical device safety information institute, which the MFDS has entrusted with this work. Class 1 devices, such as basic instruments with almost no potential risk.
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.
1. File the notification; 2. Check of the notification (5 days); 3. Notification accepted.
Outcome: An accepted notification, valid for 5 years and renewable. Valid for 5 years.
Legal basis: Medical Devices Act, Articles 6 and 15; Enforcement Rule of the Medical Devices Act, Article 4
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, not an actual time. Periods of 5 days or less are counted in working hours. | 5 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in South Korea: Drug-device combination products, Class 2 medical device certification, 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.