Regulatory Authority
Ministry of Food and Drug Safety (MFDS)
Classification
I, II, III, IV
Quality system
Quality System compliance to the Korea Good Manufacturing Practice requirements (partly harmonized with the ISO 13485:2016: 2003 requirements).
Medical Devices are subject to registration.
Foreign manufacturers shall appoint an Authorized Local Representative (Korea License Holder-KLH) who will be responsible for post-market surveillance.
As regards Class I devices, the pre-market notification must be sent online to the Competent Authority and it is not mandatory to possess the KGMP certificate.
As regards Class II, III and IV devices it is necessary to submit a registration application and in order to be granted with the license it is essential to obtain the KGMP Certificate following the KGMP Audit.
Applicant
Korea License Holder (KLH).
Timeframe and fees
Class I: 1 month
Class II: 4-6 months
Class III: 6-10 months
Class IV: 6-10 months
Validity
Issued notification and registrations do not have any validity limits. The KGMP Certificate is valid for 3 years.
Labelling and documentation language
Documentation and labelling must be provided in Korean.
