Customized Law Information

申请针对性法令信息

Customized Law Information
申请针对性法令信息
Customized Law Information Detail
* Title标题 About Medical device regulations
* Status处理情况 Completed
* Author作者 C*roly Date申请日期 2021.09.24
* Content内容 Since Medical Device Act has been constantly updating, but there is no official English version of the law, so it is difficult for us to understand all the requirements stated in legislation. Also, there are different regulations on medical device other than 의료기기법 시행령, 의료기기법 시행규칙 and 의료기기법, for example, 의료기기 표시·기재 등에 관한 규정. Is there a website that summarized all the law information about medical devices, and maybe in English?
* Purpose申请目的 I am from a Hong Kong medical device manufacturing company, we are exploring the possibility to sell our medical products into Korea. Thus, we would like to study thoroughly on the Korea medical device regulation.

Customized Law Information Reply
Answerer回答者 Admin Date回答日期 2021.10.28
Contents回答内容

Thank you for your inquiry.

 

 

Following is the answer to your inquiry from Customized Practical Law Information.

 

 

Law information regarding medical device can be found on the following webpages :

 

You can check the latest legislation via

Korean Law Information Center https://www.law.go.kr/LSW/eng/engMain.do?eventGubun=060124  

- Ministry of Food and Drug Safety https://www.mfds.go.kr/eng/index.do

 

 

 

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