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 that regulation of medical devices fall under the auspices of the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration or KFDA).
MFDS Classification of Medical Devices
South Korea's medical device classification scheme is similar to that of Europe. There are four classes of medical devices: Class I, II, III and IV. The classification rules are spelled out in Korean FDA Notification 2011-49. Our office in Korea can assist you in determining the proper classification of your medical device and going through the MFDS approval process.
Preparation of Korean MFDS (KFDA) Medical Device Registration Documents
If you have never before exported products to South Korea, you must first appoint a Third Party License Holder before beginning a device registration with the South Korean MFDS. Manufacturers without a direct office in South Korea are not allowed to submit medical device registrations to the MFDS, as the third party license holder performs this task and controls the registration. Emergo Group can assist you with South Korea 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. Korea Good Manufacturing Practice (KGMP) requirements.