Local Representation in Korea Appointing a Korea license holder is to be taken seriously. If you don’t, you may end up in a dead end with products you cannot put on the market. Here below we get into the details of what is a license holder, its responsibilities and other topics. It came from the…
Following our webinar series where we focus on medical devices registration in South Korea, we also made it possible to join, share and discuss topics related to Korean medical devices regulation and exports to Korean market via the hashtag #medical2korea. It can be used for the following : Tweet Chats (once a week) Ad-hoc advices…
Background Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard for distributors operating in South Korea. Is your distributor ready ? After strengthening its regulation for license holders and require them to appoint a dedicated Quality Manager (effective since July 2014), MFDS is now regulating the distribution…
In the following pictures we added an overview of the clinical trial regulation in Korea. It gives an overview of the process for clinical study in Korea. We recently had lots of discussions on how to conduct studies we thought a brief reminder would be welcome. The first table is about the process when investigator…
We recently launched our webinar series where we focus on medical devices registration in South Korea. We address different topics such as : How to set up the best strategy to sell your medical device in South Korea: distributors, legal terms How to get clearance from a regulatory point of view: Korean Good Manufacturing Practice,…