Seegene's COVID-19 test authorized for emergency use in Korea

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...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

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 HSA revises guidance and technical documents

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...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

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,...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India issues new draft IVD rules and updated classifications for rehab devices

Indian medical device market regulators have published new draft in vitro diagnostic device rules and made them available for industry comment. In addition, Indian...

France – Un système innovant pour l’administration du nez vers le cerveau de médicaments...

EVEON, concepteur et fabricant de dispositifs médicaux pour la préparation et l’administration de médicaments, annonce le lancement du projet de consortium européen INDENEO, pour le Rare...

Australia – Australia updates guidance on implantable medical devices, required six-monthly report

Australia’s Therapeutic Goods Administration has issued a number of new pieces of guidance that medical device manufacturers doing business in the country should review...

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