South Korea · Ministry of Food and Drug Safety · Software as a medical device
Review target
80 working days
regulation
Legal time limit
-
Not published
Steps
3
4 requirements
Application fee
₩1,495,000
Annex 16
Since 2025, software as a medical device and other devices that use digital technology such as AI fall under the Digital Medical Products Act. Class 3 and 4 products, and products not yet classified, need an MFDS permit. Most Class 2 products are certified. The forms list 80 working days when clinical evaluation data, a change control plan or professional-use software data are reviewed. Standalone medical software, embedded software, and devices that use AI, robotics, information technology or virtual reality, in Classes 2 to 4.
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 digital device permit with clinical evaluation data review (electronic filing) is ₩1,495,000 for Annex 16.
1. Apply for a permit or certification; 2. Review (80 days); 3. Permit or certificate issued.
Outcome: A permit or certificate that also counts under the Medical Devices Act.
Legal basis: Digital Medical Products Act, Articles 2, 3, 8 and 12; Enforcement Rule of the Digital Medical Products Act, Articles 3 and 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 80 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 |
|---|---|
| Digital device permit with clinical evaluation data review (electronic filing)Application · Annex 16 | ₩1,495,000 |
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, In vitro diagnostic device permit (Classes 2 to 4), In vitro diagnostic device certification (Class 2), In vitro diagnostic device notification (Class 1), 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.