China- Medical Device Administrative Control System (MDACS)
During the life-cycle of a medical device, changes may take place from time to
time. To safeguard public health, the information in the Medical Device...
France – Ballons gastriques Allurion : recommandations pour limiter la survenue de complications graves
Les ballons gastriques de la marque Allurion sont des dispositifs médicaux utilisés chez des patients en situation de surpoids ou d'obésité. Nous appelons à...
USA – FDA issues final guidance user fees for combination products
The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the...
USA – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
The opioid epidemic is a serious and complex public health emergency facing the United States. The Agency has already taken significant steps to decrease...
Europe – Regulation (EU) 2024/1689 of the European Parliament and of the Council of...
The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for...
USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...
Europe – Regulation (EU) 2024/1860 of the European Parliament and of the Council of...
Regulations (EU) 2017/745 (3) and (EU) 2017/746 (4) of the European Parliament and of the Council establish a regulatory framework to ensure the smooth functioning of the internal market...
International – Lancement de la plateforme MeDevIS pour améliorer l’accès aux technologies et dispositifs...
L’Organisation mondiale de la Santé (OMS) annonce le lancement en ligne du Système d’information sur les dispositifs médicaux (MeDevIS), la première plateforme mondiale d’échange...
Europe – MDCG 2020-16 Rev.3 – Guidance on Classification Rules for in vitro Diagnostic...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
France – Déclarer l’indisponibilité d’un dispositif médical : la procédure évolue
A partir du 1er septembre 2024, la procédure pour anticiper et gérer l’indisponibilité de dispositifs médicaux (DM) et dispositifs médicaux in vitro (DMDIV) évolue, dans la continuité...
