South Korea · Ministry of Food and Drug Safety · Software as a medical device
Review target
5 working days
regulation
Legal time limit
-
Not published
Steps
3
1 requirements
Application fee
-
Class 1 digital medical devices, including low-risk software, are notified to a certification agency designated by the MFDS. The form lists a 5-day processing period. Class 1 digital medical devices.
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.
Legal basis: Digital Medical Products Act, Article 8; Enforcement Rule of the Digital Medical Products Act, Article 6
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 1 medical device notification, Class 2 medical device certification, Medical device permit (Classes 2 to 4), Innovative medical device designation, Digital medical device permit or certification (including software). 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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.