South Korea · Ministry of Food and Drug Safety · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
1 requirements
Application fee
-
The MFDS can designate high-tech devices that clearly improve safety or effectiveness over existing devices or treatments as innovative medical devices. Designated devices can get staged review during development and priority review of the permit application. Devices using advanced technology such as information technology, biotechnology or robotics that are clearly better than existing options.
1. Innovative device designation; 2. Staged review during development; 3. Priority review of the permit; 4. Permit or certification.
Outcome: Designation, then a permit or certification reviewed ahead of other applications.
Legal basis: Medical Device Industry Promotion and Innovative Medical Device Support Act, Articles 2(4), 21 and 22
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in South Korea: Drug-device combination products, Class 1 medical device notification, Class 2 medical device certification, Medical device permit (Classes 2 to 4), 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 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.