KFDA Medical Device Registration and Approval in South Korea
South Korea is emerging as a prominent medical device market. With a GDP ranking in the world’s top 15, and rising per capita healthcare expenditures, the medical device market can be lucrative for foreign manufacturers. In fact, imports account for the vast majority of the total market.
The legal framework for medical devices is provided by the Medical Devices Act which stipulates regulation of medical devices to be under the auspices of the Korea Food and Drug Administration (KFDA). The KFDA is a subdivision of the Ministry of Health and Welfare (MHW).
KFDA Classification of Medical Devices
Korea's medical device classification scheme is similar to Europe. There are four classes of medical devices: Class I, II, III and IV. The classification rules are spelled out in KFDA Notification 2000-37. Our office in Korea can assist you in determining the proper classification of your medical device.
Preparation of KFDA Registration Documents
If you have never before exported products to Korea, you must first appoint a Third Party License Holder before beginning a device registration with the KFDA. Manufacturers without a direct office in Korea are not allowed to submit medical device registrations to KFDA as the third party license holder performs this task and controls the registration. Emergo Group can assist you with Third Party License Holder representation.
The next step in the process is to create a Technical File for the products. The scope of a Korean Technical File is similar to a European Technical File/Design Dossier or a US FDA 510(k) or PMA submission. However, many differences exist and all documents must be submitted in Korean. We can assist you with KFDA Technical File preparation and our office in Seoul will coordinate document translation and the entire submission to KFDA. We can also ensure that your company is in compliance with Korea Good Manufacturing Practice (KGMP) requirements.
