The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised Notified Body guidance documents. The aim of such guidance is to address some of the best practice expected from manufacturers and Notified Bodies. The guidance documents can be found on the below link: 1. NBOG BPG 2014-3 – Guidance for manufacturers and…
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,…
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)…
borderline and classification medical devices: UPDATED MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.16 (07-2014) Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable…
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…
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…