International – Google’s DeepMind opens ‘breakthrough’ protein database to the world

Last year, DeepMind – which was acquired by Google in 2014 – published research that its AlphaFold programme could accurately predict a protein’s structure...
Le Cœur CARMAT (CARMT TAH) éligible au forfait innovation (HAS) sous conditions de nouvelles données cliniques

Europe – CARMAT : annonce la première implantation humaine de son cœur artificiel Aeson®...

CARMAT, concepteur et développeur du cœur artificiel total le plus avancé au monde, visant à offrir une alternative thérapeutique aux malades souffrant d’insuffisance cardiaque...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Is my software regulated?

Flowcharts showing which software products are regulated as a medical device, and those that are not...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – TGA international engagement strategy 2021-2025

The Therapeutic Goods Administration (TGA), as part of the Australian Department of Health, supports the Department's strategic priorities for an affordable, accessible, efficient and...
The Cosmetic Hygiene And Safety Act Reshaped Taiwan's Cosmetic Regulation

Taiwan – Final exemption list, cybersecurity guidelines, COVID-19 measures and more (Update)

Final list of medical devices exempt from QMS certification requirements now available In a significant development, the Taiwan Food and Drug Administration (TFDA) has published...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – “UE for PDC”: Little bits of usability engineering for platform-device companies

In light of the European Medical Devices Regulation (MDR) coming fully into effect, there will be even more focus on combination product manufacturers to...

USA – CDRH official offers advice for smoother Q-submission meetings

A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings,...
New guidance on biologics affects authorized generics

USA – FDA seeks expanded authority to boost device supply chain

FDA has called for new powers and more funding to improve its ability to prevent medical device shortages. Janet Woodcock, the acting FDA commissioner, said...
TEAM-NB : Survey on NBs applications against IVD new regulation

Europe – Team-NB Position Paper on “implant card”

Team-NB members approved a new position paper prepared by an internal task force of 12 participants and entitled: “Team-NB Position Paper on a risk-based...

Europe – MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations

For clinical investigations under Regulation (EU) 2017/745 (MDR) the Competent Authorities (CAs) use Eudamed2 to obtain a Union-wide unique single identification number (the ‘CIV-ID’),...

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