South Korea · Ministry of Food and Drug Safety · Diagnostics (IVD)
Review target
80 working days
regulation
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
₩1,495,000
Annex 3, added 2026-09-18
In vitro diagnostic devices have their own law. Class 3 and 4 IVDs, and Class 2 IVDs that are not equivalent to permitted ones, need a permit from the MFDS. The review covers technical documents and, where needed, clinical performance data. A companion diagnostic can be reviewed together with its medicine. Class 3 and 4 IVDs, such as HIV or hepatitis tests, and new Class 2 IVDs.
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 ivd permit with technical document and clinical performance review (electronic filing) is ₩1,495,000 for Annex 3, added 2026-09-18.
1. Submit the permit application; 2. Joint review with the medicine (companion diagnostics); 3. Review of technical documents and clinical performance (80 days); 4. Permit issued.
Outcome: A permit that also counts as a permit under the Medical Devices Act. Valid for 5 years.
Legal basis: In Vitro Diagnostic Medical Devices Act, Articles 5 to 7 and 11; Enforcement Rule, Article 5
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 |
|---|---|
| IVD permit with technical document and clinical performance review (electronic filing)Application · Annex 3, added 2026-09-18 | ₩1,495,000 |
Other routes in South Korea: In vitro diagnostic device certification (Class 2), In vitro diagnostic device notification (Class 1), 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.