Medical devices and IVDs are separated into four classes of increasing risk in Korea: Class I, II, III and IV, as per the MFDS process chart. Class I devices are eligible for a simplified notification process. 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).
Types of medical device Technical Files in Korea
The Technical File contains information about the medical device design, materials, intended use, manufacturing methods, and so on. The Korean Technical File is similar to a European Technical File or US FDA 510(k) submission. Class II and higher devices will need to submit testing information with their Technical File, and most products will require additional performance testing to meet Korean requirements. Additionally, Class IV devices require a Summary Technical Document (STED) submission, in addition to the standard application.
Class II, III, and IV medical devices with new technology or without a Substantially Equivalent (SE) device registered will need to submit clinical data to MFDS for review, in addition to the standard technical file. The Clinical Data Review application (formerly Safety and Efficacy Review – SER) is a comprehensive type of submission that is similar to a European Design Dossier or US FDA PMA submission.
Emergo can prepare your MFDS (KFDA) Technical File
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:
- Classification determination
- Assistance with identifying a Substantially Equivalent device
- Reviewing existing technical documentation prepared for the medical device to see if it meets Korea's requirements
- Support with determining appropriate Type Testing to satisfy MFDS requirements
- Preparation of the Technical File and Clinical Data Review application
- Filing with MFDS
We also assist companies without a physical location in South Korea with Korea Good Manufacturing Practice (KGMP).