KFDA監(jian)管機(ji)構介(jie)紹

韓(han)國衛生福利部（MinistryofHealthandWelfare，MHW），簡稱衛(wei)生部，主(zhu)要負責管食(shi)品、藥品、化妝(zhuang)品和(he)醫(yi)療器械的(de)管理，是最主(zhu)要的(de)衛(wei)生保健部門。依照(zhao)《醫(yi)療器械法》，韓(han)國衛(wei)生福利(li)部下屬的(de)食(shi)品藥品安(an)全部（MinistryofFoodandDrugSafety，MFDS）負責對醫療器械的監管工作。

韓國醫療器械(xie)法把醫療器械(xie)分(fen)為4類(lei)（Ⅰ、Ⅱ、Ⅲ、Ⅳ），這(zhe)種分(fen)類方法(fa)與歐(ou)盟對醫療器械的分(fen)類方法(fa)非常(chang)相似。

Ⅰ類：幾乎沒(mei)有潛在危險的醫療器械(xie)；

Ⅱ類(lei)：具有低(di)潛(qian)在危險(xian)的(de)醫療器械(xie)；

Ⅲ類(lei)：具有中度潛在危險的醫療器械；

Ⅳ類(lei)：高風險(xian)的(de)醫療器械(xie)。

醫療器械分類依據：危(wei)險程度、與(yu)人體的接(jie)觸面積(ji)和(he)接(jie)觸時間、產(chan)品的安(an)全性(xing)和(he)有效性(xing)。

KFDA注冊流程

韓國KFDA的技術文(wen)件準(zhun)備

Medical devices and IVDs are separatedinto four classes of increasing risk in Korea: Class I, II, III and IV, as perthe . 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 , 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.