커뮤니티 메디행정사사무소를 찾아주셔서 감사합니다.

공지(공유)사항

Regulation website related to Medical device Korea

  • Rep
  • 2023-09-12 23:12:09
  • hit555
  • vote1
  • 220.120.196.35

1) MFDS (Korea FDA) English website : https://www.mfds.go.kr/eng/index.do

    Korean website : https://udiportal.mfds.go.kr/

2) English Medical Device Act : https://www.law.go.kr/LSW/eng/engMain.do

3) National Institute of Medical Device Safety Information 
  - Mostly Class I, II registration authority (Class III, IV is under MFDS).
  https://www.nids.or.kr/

4) Medical Device GMP audit institute website
  - KTL : https://www.ktl.re.kr/main.do

  - KTR : https://www.ktr.or.kr/

  - KCL : https://www.kcl.re.kr/site/main/index001

  - KTC : http://www.ktc.re.kr/web_united/

게시글 공유 URL복사
댓글작성

열기 닫기

댓글작성