Post market surveillance

Post market surveillance

Post market surveillance in Europe One of the changes in the new European Medical Devices Regulation (MDR 2017/745) is the strengthened post market surveillance requirements for medical device manufacturers in order to register their product in the European Union. This requires manufacturers for each medical device to plan, establish, document, implement, and maintain a post…

KGMP guideline Rev.4 in English

KGMP guideline revision The Korean GMP (KGMP) guideline has been updated earlier this year (2016) and even if it was only provided in Korean we prepared a translated version in English. More details were provided in the guideline and the case of in vitro diagnostic equipment was considered since those were reclassified as medical devices.…

CMEF 2015 exhibition in Shanghai

China International Medicinal Equipment Fair (CMEF), founded in 1979, is held twice a year – spring and autumn. After 30 years of continuous innovation and self-improvement, CMEF has become the largest exhibition of medical equipment, related products and services in the Asia-Pacific region. The exhibition widely covers ten thousands of products such as medical imaging,…

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…

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…

medical device registration in korea – appointing medical device quality manager for class 1 products

Medical device registration in Korea: appointing medical device quality manager for class 1 products In case of class 1 medical devices, the voluntary system that allow manufacturers/importers to manage quality control internally was adopted. However, the current medical device act does not require the manufacturers/importers that are seeking licensing to employ the medical device quality…

korean labeling requirements

Korean labeling requirements: One of our subscribers raised the point of labeling requirements specifically asking if it was necessary to include the “manufactured by…” and “Made in …” on the labels. Let’s review below what are the requirements including this one so that we get the overall picture. On the device label product name model…