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 considers both device risk and predicate(s). There are four classes of medical devices: Class I, II, III and IV. Our office in Korea can assist you in determining the proper classification of your medical device as well as going through the MFDS approval process.
Preparation of Korean MFDS (KFDA) Medical Device Registration Documents
Before beginning a device registration with the South Korean MFDS, you must first appoint a Korea License Holder. Foreign manufacturers without a direct office in South Korea are not allowed to submit medical device registrations to the MFDS; the Korea License Holder performs this task and controls the registration. Emergo can assist you with South Korea 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, some differences do exist and all documents must be submitted in Korean. Additionally, most Class II-IV products require additional testing to Korean specific product standards, as part of their registration application. Korea Good Manufacturing Practice (KGMP) certification is also a requirement when registering all Class II, III, and IV devices in South Korea. Korea Good Manufacturing Practice (KGMP) requirements.