South Korea – Updates: Innovative device designations, IVD Act enforcement
Regulators in South Korea have issued two recent revisions to medical device and in vitro diagnostic (IVD) registration and approval requirements of note for...
India – Indian regulators add to list of medical device testing laboratories
Indian regulators have updated their list of organizations qualifying as Medical Device Testing Laboratories (MDTLs), adding three entities to perform testing and evaluation of...
Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The...
Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The...
USA – FDA finalizes rule for over-the-counter hearing aid devices
The US Food and Drug Administration has finalized rules establishing over-the-counter (OTC) availability for certain types of hearing aids in order to improve public...
China – Update: Class I medical device filing rules, UDI standards
China’s National Medical Products Administration (NMPA) has amended guidance on record filing requirements for low-risk Class I medical devices in order to reflect broader...
France – Publication du référentiel d’interopérabilité et de sécurité des DM de télésurveillance
PARIS (TICpharma) - Un arrêté publié au Journal officiel du 31 juillet 2022 a approuvé le référentiel d'interopérabilité et de sécurité des dispositifs médicaux...
USA – FDA: Nearly 700 breakthrough medical device designations since 2015
The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review...
Europe – New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR
The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance covering designation, re-assessment and notification of Notified Bodies (NBs) as well as...
France – Arrêté du 25 juillet 2022 portant approbation du référentiel d’interopérabilité et de...
Le ministre de la santé et de la prévention,
Vu le règlement (UE) 2016/679 du Parlement européen et du Conseil du 27 avril 2016 relatif...
