Kobridge

Hashtag #medical2korea

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…

Medical Device Distribution Quality Management

Medical Device Distribution Quality Management in Korea

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…