韩国KFDA的技术文件准备

   Medical devices and IVDs are separatedinto four classes of increasing risk in Korea: Class I, II, III and IV, as perthe MFDS process chart. Class I devices are eligible for asimplified notification process. Class II, III and IV devices require thepreparation of a Technical File that will be submitted as part of the medical deviceregistration with the Korean Ministry of Food and Drug Safety (MFDS), formerly the Food and DrugAdministration (KFDA).

Types of medical device Technical Filesin Korea

The Technical File contains informationabout the medical device design, materials, intended use, manufacturingmethods, and so on. The Korean Technical File is similar to a EuropeanTechnical File or US FDA 510(k) submission. Class II and higher devices willneed to submit testing information with their Technical File, and most productswill 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 IVmedical devices with new technology or without a Substantially Equivalent (SE)device registered will need to submit clinical data to MFDS for review, inaddition to the standard technical file. The Clinical Data Review application(formerly Safety and Efficacy Review – SER) is a comprehensive type of submissionthat is similar to a European Design Dossier or US FDA PMA submission.

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