Medical devices are separated into four classes of increasing risk in Korea: Class I, II, III and IV, as per the MFDS process chart. Class II, III and IV devices require the preparation of a Technical File that will be submitted as part of the medical device registration with the Korean Ministry of Food and Drug Safety (MFDS), formerly the Food and Drug Administration (KFDA).
Class II, III, and IV medical devices require the preparation of a General Technical File. This is a document that contains information about the medical device design, materials, intended use, manufacturing methods and so on. The Korean General Technical File is similar to a European Technical File or US FDA 510(k) submission.
Class II, III, and IV medical devices without a Substantial Equivalent (SE) registered with the MFDS require the preparation of a Safety and Efficacy Review (SER) Technical File. This is a very comprehensive type of submission that is quite similar to a European Design Dossier or US FDA PMA submission. SER Technical Files require the submission of clinical data as well.
Our experienced team in Seoul has been assisting medical device and IVD companies with MFDS submissions and Technical File preparation for many years. Our services include:
We also assist companies without a physical location in South Korea with Third Party License Holder representation, acting as the primary liaison with the MFDS and coordinating and maintaining the registration of medical devices. If you do not have a quality system that conforms to Korea Good Manufacturing Practice (KGMP), we can assist with that as well.
Please note that we currently assist with IVD registration in South Korea.