South Korea · Ministry of Food and Drug Safety · Combination products
Review target
-
Not published
Legal time limit
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Not published
Steps
4
2 requirements
Application fee
-
Korea has no separate combination product route. A drug-device combination follows the main function. If the main function is the device, a device permit covers the whole product. If the main function is the drug, the drug permit covers the device part. Drugs combined with digital medical devices can be licensed as digital convergence drugs. Products that combine a medicine with a medical device or a digital medical device.
1. Decide the main function; 2. Drug route if the main function is the drug; 3. Device route if the main function is the device; 4. Single permit decision.
Outcome: One permit under the law that matches the main function.
Legal basis: Pharmaceutical Affairs Act, Article 31(7); Medical Devices Act, Article 6(6); Digital Medical Products Act, Articles 2(3) and 29
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: New drug item permit, Item permit for data-submission drugs (including incrementally modified drugs), Generic drug item permit (bioequivalence), Item notification for monograph and standard-formula products, Priority review designation (GIFT), Conditional item permit, Orphan drug designation, Item permit for advanced biological products (cell and gene therapy), 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 or explore them in the .
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.