TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Face masks and respirators that are regulated by the TGA

Face mask regulation Non-sterile face masks (including respirators) that are intended, by their manufacturer, to prevent the transmission of disease between people, or are intended...
New guidance on biologics affects authorized generics

USA – Device importers’ COVID questions answered by FDA

The US Food and Drug Administration (FDA) has launched two new webpages related to medical device importation, registration and listing during the COVID-19 pandemic. The...
Eudamed : un report de 2 ans à mettre à profit pour mieux se préparer au RDM

Europe – European Commission identifies which Eudamed data to be publicly accessible

European Commissioners have issued a new factsheet detailing types of information related to medical devices and IVD products to be accessible to the public...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – MDCG 2020-14 : Guidance for notified bodies on the use of MDSAP...

Under the MDR/IVDR, most conformity assessment procedures consist of both the quality management system audit and the assessment of a device’s safety and performance. Notified...

Europe – Researchers develop fast triple antibody test

With more than 40 percent of people with COVID-19 showing no symptoms, many people want to know whether or not they have had the...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – MDCG explains how notified bodies can use MDSAP audit reports

In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP)...

International – Strategies to Prevent Component Shortages During a Crisis

COVID-19’s impact on manufacturing has created a number of business roadblocks, including order cancelations, large fluctuations in demand, supply chain issues, and reduced production...

USA – Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those...

USA – Pandemic prompts mask, ventilator EUAs from FDA

This week, the US Food and Drug Administration granted emergency use authorizations (EUAs) to three ventilator-related devices, issued an umbrella EUA for disposable, single-use...

USA – US FDA launches pilot program for RFD and Pre-RFD electronic submissions process

The US FDA’s Office of Combination Products (OCP) announced a pilot program in the Federal Register to help the OCP evaluate a potential new electronic submissions process for...

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