Medical Device Registration in
Ministry of Health
Medical Device Regulation
Class I, II, III, IV
- Determine the device classification
- Appoint your Authorised Korean License holder
- Class I devices will be subjected to the Pre-market Notification process. Technical File review by MFDS is not necessary
- Class II, III and IV, with an equivalent device in Korean Market, will be subjected to the Pre-Market Approval pathway. Clinical evidence is not necessary. Apply for KGMP Certification
- Submit the Technical File to MFDS authorized auditor and carry out conformity assessment.
- Once approved, the device can be marketed in South Korea
Class II, III, IV devices to submit:
- Technical File
- QMS certification
- Clinical Trial Reports
- Test Reports
- Product Description
- Letter of Authorization
- Labels, IFUs or User Manuals
- Class I (NIDS) – 1 Month
- Class II(NIDS)- 3-5 months
- Class III- 9 months
- Class IV – 9-12 months
Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.
Label and instructions for use must be provided in Korean.