Advice for Management of Clinical trials in relation to Coronavirus

UK – Biggest Regulatory Challenge is Software Safety

John Wilkinson, outgoing director of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), answered Focus questions via email on everything from Brexit to...

France – Coronavirus : Thuasne se lance dans la production de masques barrières réutilisables

En pleine épidémie du coronavirus, Thuasne apporte sa contribution à la fabrication de moyens de protection pour la population saine. Spécialisé dans la fabrication de dispositifs...
The Cosmetic Hygiene And Safety Act Reshaped Taiwan's Cosmetic Regulation

Taiwan – TFDA suspends on-site inspections for foreign medical device manufacturers

The Taiwan Food and Drug Administration (TFDA) announced (link in Mandarin) the temporary suspension of on-site inspections of overseas medical device manufacturers for the duration...
FDA Approves First Contraceptive Mobile App

USA – FDA Approves First Contraceptive Mobile App

A Swedish startup company obtained US Food and Drug Administration (FDA) approval Friday for the country’s first mobile medical app indicated for contraceptive use. The...
CDRH Proposed Guidances for Fiscal Year 2020

USA – CDRH Drafts New Framework to Create a Pediatric Device Safety Network

A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical...
Epidemiological Evidence on the Adverse Health Effects Reported in Relation to Mercury from Dental Amalgam

USA – FDA – MD Safety Action Plan to enhance post-market safety : Statement...

In April of this year, the FDA released its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, which described recent actions we’ve taken...
PredictSURE IBD gains CE mark, set for UK and EU launch

UK – PredictSURE IBD gains CE mark, set for UK and EU launch

Acquisition of the CE mark enables PredictImmune to market PredictSURE IBD, now the first validated biomarker based prognostic test in inflammatory disease, across the...
SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

Europe – NEW REGULATION – GUIDANCE

The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices. New regulations Guidance documents to assist stakeholders...
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – Device makers seek transparency on Breakthrough Devices Program

A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority...
Top 10 Patient Safety Concerns in 2019

USA – Top 10 Patient Safety Concerns in 2019

Released in conjunction with National Patient Safety Awareness week, ECRI Institute's Top 10 Patient Safety Concerns for 2019 raises the profile of safety issues that pose...

NOS PROCHAINES FORMATIONS