UK – MHRA releases spate of new guidelines on decentralized manufacturing
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for...
USA – FDA issues guidance on transferring 510(k) ownership
The US Food and Drug Administration (FDA) recently released a draft guidance that clarifies the responsibilities of new owners of 510(k) clearances when products...
Europe – EU plan would limit Chinese device makers in Europe
European Union member states this week voted to support a plan to adopt measures that would restrict Chinese medical device makers’ access to the...
USA – FDA final guidance adds more details to Q-Sub program
The US Food and Drug Administration has finalized an updated guidance on its Q-Submissions program that allows medtech companies to engage with regulators early...
France – Nouvel avis sans recommandation de la Cnedimts sur le remboursement d’un DM...
SAINT-DENIS (Seine-Saint-Denis) (TICpharma) - La commission nationale d'évaluation des dispositifs médicaux et des technologies de santé (Cnedimts) a rendu un avis sans se prononcer...
Europe – Study supporting the monitoring of the availability of medical devices on the...
Commissioned by: The European Commission’s Directorate-General for Health and Food
Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA)
• Aim: To support...
USA – Medical Devices Regulatory Update / FDIS 10993-1 Released: Requirements and General Principles...
The Final Draft International Standard (FDIS) of ISO 10993-1 has been released launching the 8-week ballot period and signaling important changes ahead for medical...
UK – The Medical Devices (Amendment) (Great Britain) Regulations 2025 (Draft)
The Secretary of State in exercise of powers conferred by sections 15(1), 16(1)(a), (b), (c), (e), (g) and (i),17(1)(b) and (c) of the Medicines and Medical...
USA – FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s...
Australia – Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)
The purpose of this guidance is to outline the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or...
