South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations.
The announcements include:
...
China – Chinese regulators recommend clinical evaluation paths for certain medical devices
China’s Center for Medical Device Evaluation (CMDE) published several new pieces of guidance that medical device manufacturers doing business in the country should review...
USA – FDA eases UDI compliance requirements for some low-risk medical devices
The US Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance...
South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations.
The announcements include:
...
Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR
A notified body associated with the Agency of Medicines and Medical Products (AEMPS) has become the first Spanish group designated to assess products under...
Japan – Japan updates guidance on QMS Conformity Survey applications
Japan’s Ministry of Health, Labour and Welfare (MHLW) has updated its guidance on documents that medical device market registrants must submit when applying for...
Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed...
Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)...
France – Emballages de dispositifs médicaux : le LNE accrédité Cofrac
Afin de mettre leurs dispositifs médicaux sur le marché, les fabricants doivent démontrer la performance de leurs différents emballages. Ils sont également tenus de...
Singapore – Singapore adds HIBCC to list of UDI issuing agents
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has announced that a new designated issuing agency (IA) has been added to its...
Europe – Notified bodies have yet to issue MDR certificates for 85% of legacy...
Notified bodies have yet to issue Medical Device Regulation certificates for more than 85% of the products previously certified under the old directives,...
