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 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…

Kobridge Meetup

We recently launched our Meetup group where we focus on medical devices registration in South Korea. We will be able to connect locally whatever the place we visit. We want to give the opportunity to meet us in case we visit your town or during trade shows. To check our meetup page click on the…

korean medical devices regulation update 2014-142

Notification of regulation amendment regarding approval, notification and evaluation of medical devices in Korea. A) Implantable Medical Device B) Restricted substances C) Intended Use D) Clinical Evaluation E) Medical apps Korean medical devices regulation update 2014-142 A) Implantable Medical Device The definition of Implantable medical device and its application (Article 2 and Article 5) 1)…

MDSAP pilot program

Statement of Cooperation Among FDA – TGA – ANVISA – HPFB: MDSAP pilot According to the SOC (Statement of Cooperation), the “Participants” composed of the The United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency (ANVISA), and the Canadian Health Products and Food Branch (HPFB) aims…