Eruope – Normes harmonisées relatives aux DM et DMDIV

Les décisions suivantes ont été publiées au JOUE du 15.04.21 : Décision d’exécution (UE) 2021/609 de la Commission du 14 avril 2021 modifiant la décision d’exécution...

Vietnam – Vietnamese Ministry of Health proposes new decree for medical device regulation

The Vietnamese Ministry of Health (MoH) published a draft decree (download link, in Vietnamese) intended to replace Decree No. 36/2016/ND-CP​ and its amendments, which form the...
FDA Approves First Contraceptive Mobile App

International – Considering icons for mobile applications and connected medical devices

It seems like there is a new smartphone, mobile app, or connected device on the market every month. These increasingly “smart” mobile applications, dashboards,...

USA – FDA issues final rule removing certain software from medical device regulations

The US Food and Drug Administration (FDA) has issued a final rulemaking that eliminates certain software intended to transfer, store or display clinical laboratory...

France – Accélérer l’évaluation des perturbateurs endocriniens

Dans le cadre de la seconde Stratégie nationale sur les perturbateurs endocriniens (SNPE 2), l’Anses a élaboré une liste de substances d’intérêts et identifié...

Europe – Euro Roundup

Big pharma trade group EFPIA has called on the European Commission to create a multi-stakeholder forum to discuss how to improve access to medicines....

France – Plan Healthtech: trois axes de travail pour faire émerger des champions français...

PARIS (TICpharma) - La banque publique d'investissement Bpifrance, les cabinets de conseil Boston Consulting Group (BCG) et BioUp, et France Biotech ont présenté le...
HAS - Webinaire sur l'évaluation des dispositifs médicaux : visionnez le replay

France – Revue rapide sur les tests antigéniques automatisés de détection du SARS-CoV-2 sur...

Le Collège de la Haute Autorité de santé a rendu trois avis le 24 septembre 2020, le 8 octobre 2020 et le 27 novembre...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – MDCG 2021-5 Guidance on standardisation for medical devices

This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in...

USA – US FDA announces medical device testing laboratories accredited under ASCA program

The US Food and Drug Administration has designated more than 50 laboratory sites to participate in the agency’s Accreditation Scheme for Conformity Assessment (ASCA)...

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