커뮤니티 메디행정사사무소를 찾아주셔서 감사합니다.
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/
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