South Korea · Ministry of Food and Drug Safety · Diagnostics (IVD)
Review target
5 working days
regulation
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
₩130,000
Annex 3, added 2026-09-18
Class 2 IVDs that the MFDS lists for certification and that are equivalent to permitted products are certified instead of permitted. The certification form lists a 5-day processing period. Class 2 IVDs equivalent to IVDs already permitted or certified.
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.
The ivd certification (electronic filing) is ₩130,000 for Annex 3, added 2026-09-18.
1. Apply for certification; 2. Certification review (5 days); 3. Certificate issued.
Outcome: A certificate. Valid for 5 years.
Legal basis: In Vitro Diagnostic Medical Devices Act, Article 5; Enforcement Rule, Article 5(2)(2)
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 |
|---|---|
| IVD certification (electronic filing)Application · Annex 3, added 2026-09-18 | ₩130,000 |
Other routes in South Korea: In vitro diagnostic device permit (Classes 2 to 4), 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.