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Medical Device Post Market Surveillance in Canada

Health Canada collects post-market information from a wide variety of sources after products are approved for sale in the Canadian market, then evaluates information to come up with appropriate safety measures involving medical devices. Signal detection and assessment Health Canada continuously receives and evaluates Medical Devices Incident Reports and Post-Market Adverse Reaction Reports. Through the…

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…

Guideline

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.…

Shanghai

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,…

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…

Pressure Pump Mediacl Device

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…