South Korea KFDA

As the main health care authority, the Ministry of Health and Welfare (MHW) of South Korea is mainly responsible for the management of foods, drugs, cosmetics and medical devices.

In accordance with the Medical Device Law, the Ministry of Food and Drug Safety (MFDS) subordinated to the MHW is responsible for the supervision of medical devices.

The Medical Device Law of South Korea classifies medical devices into 4 types (Ⅰ, Ⅱ, Ⅲ, Ⅳ). This classification method is very similar to that of the EU.

Class I: Medical devices almost without any potential risk;
Class II: Medical devices with low potential risk;
Class III: Medical devices with medium potential risk;
Class IV: High risk medical devices.

Basis of medical device classification: hazard level, contact area and contact time to human body, safety and effectiveness of products.

 (Estimated) Time nodes of certification process:

Step 1 (1 month): Preparation stage.

Determine the product class (I, II, III, IV) and select the South Korea License Holder (KLH).

Step 2 (3 months): Apply for KGMP certificate for Class II products, accept the site audit by an authorized third-party auditor, and obtain the KGMP certificate.
Step 3 (3 months): The sample of Class II products shall be tested by a MFDS authorized laboratory for South Korea standard compliance.
Step 4 (1 month): The KLH submits technical files (technical files, test report and KGMP certificate) to the MFDS for registration and approval.
Step 5: Pay the application fee N/A
Step 6 (3 months): Registration file correction and registration approval.
Step 7: Appoint South Korea agents and distributors for product sales N/A