USA – FDA acknowledges shortcomings of Pre-Cert pilot in report
The US Food and Drug Administration (FDA) said it needs additional Congressional authority to move forward with its digital health precertification (Pre-Cert) program. While...
France – Les logiciels de diagnostic in vitro : Nouveautés introduites par le Règlement...
Le Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro est entré en application le 26 mai 2022. Parmi les nouveautés introduites par ce...
France – Cybersécurité des DM et DMDIV
Ce document est un recueil de recommandations à l’attention des fabricants de DM et DMDIV. L’objectif est de les guider pour prendre les mesures...
USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...
Europe – Notified bodies’ paper on the application of hybrid audits to quality management...
Team-NB would like to emphasise that we do not regard this document as final rule or guidance, but rather as our view/expectation for the...
UK – MHRA appoints first new UK Approved Body to certify medical devices since...
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies,...
France – France 2030: 14 lauréats pour l’appel à manifestation d’intérêt « Santé numérique »
PARIS (TICpharma) - Quatorze projets ont été sélectionnés par l'appel à manifestation d'intérêt (AMI) "Santé numérique" dans le cadre du plan France 2030, pour...
FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
Singapore – HSA to commence Phase I implementation of UDI labeling in November 2022
Singapore’s medical device market regulator, the Health Services Authority (HSA), has issued a notification indicating that Phase I implementation of its Unique Device Identification...
USA – FDA wants COVID test developers to shift from EUAs to traditional premarket...
The US Food and Drug Administration (FDA) has released updated guidance on COVID-19 diagnostic and serology testing, signaling its intention to review fewer emergency...
