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韩国KFDA注册

 
KFDA监管机构介绍
 

韩国卫生福利部(MinistryofHealthandWelfare,MHW),简称卫生部,主要负责管食品、药品、化妆品和医疗器械的管理,是最主要的卫生保健部门。依照《医疗器械法》,韩国卫生福利部下属的食品药品安全部(MinistryofFoodandDrugSafety,MFDS)负责对医疗器械的监管工作。

韩国医疗器械法把医疗器械分为4类(),这种分类方法与欧盟对医疗器械的分类方法非常相似。

类:几乎没有潜在危险的医疗器械;

类:具有低潜在危险的医疗器械;

类:具有中度潜在危险的医疗器械;

类:高风险的医疗器械。

医疗器械分类依据:危险程度、与人体的接触面积和接触时间、产品的安全性和有效性。

 

 
KFDA注册流程
 

认证流程

时间节点(时间节点均为预估)

第一步:准备阶段。确定产品分类(I,II,III,IV),选择韩代KLH

1个月

第二步:II类产品需申请KGMP证书和接受现场审核,II类产品一般是授权的第三方审核员,并获得KGMP证书

3个月

第三步:II类产品需要送样品到韩国MFDS授权的实验室进行韩国标准的测试

3个月

第四步:由韩代向MFDS提交技术文件(技术文件,检测报告,KGMP证书),进行注册审批

1个月

第五步:支付申请费用

N/A

第六步:注册文件整改,注册批准

3个月

第七步:指定韩国代理商和经销商,产品销售

N/A

 

 
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.