[MFDS] Amendment to the Notice of New Category of Medical devices

작성자 관리자 날짜 2023-07-04 20:34:25 조회수 161

The Ministry of Food and Drug Safety (hereinafter referred to as the MFDS) in Korea determines and discloses medical device categories and classes of each medical device through the "Regulations on Medical Device Categories and Class by Item (MFDS Notice)". Thus if a product that is imported into Korea is deemed a medical device, it is necessary to check the category and class of such device in order to proceed with the necessary approvals/certification/notification procedures and KGMP certification. As a reference, the number of categories specified in the Notice is currently limited to about 2,600 categories, but the following categories have been newly established through the recent amendment of the Notice. Therefore, if your company manufactures relevant products, please check the requirements on the approval process for such products through a class check.