Ministry of Health

Ministry of Health and Welfare of South Korea

Regulatory Authority

The Ministry of Food and Drug Safety (MFDS)

Medical Device Regulation

Medical Device Act (MDA)

Act on Invitro Diagnostic Medical Devices

Official Language

Korean

Classification

Class I, II, III, IV

Registration Process

• 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

Documents Required

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

Applicable QMS

KGMP Certification

Registration Timeline

• Class I (NIDS) – 1 Month
• Class II(NIDS)- 3-5 months
• Class III- 9 months
• Class IV – 9-12 months

Authorized Representative

Yes

License Validity

Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.

Special Notes

Label and instructions for use must be provided in Korean.