Ministry of Food and Drug Safety Notice No. 2014-155 was published on MFDS website. The Korean Good Manufacturing Practice (KGMP) being revised and this is a public consultation. South Korea medical device registration will be affected by this publication. The purpose here is clearly to improve the way KGMP is managed. Below is a summary…
Korean Ministry of Food and Drug Safety (MFDS) recently released a revision of its reference standard as per Ministry of Food and Drug Safety Notice No. 2014-122 affecting South Korea medical device registration. The purpose is to align with international standards related to electrical and mechanical safety. Are covered the following: radiation safety, usability, alarm…
Which one comes first among: KGMP (Korean Good Manufacturing Practice), product license, TDR (Technical Document Review) ? This is not a quiz, however often people are puzzled as to which one to apply for first. So far, the sequence has been like this: TDR product license KGMP The reason was that you needed the application…