Singapore – Singapore adds HIBCC to list of UDI issuing agents
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has announced that a new designated issuing agency (IA) has been added to its...
Europe – Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials
Now that the IVDR 2017/746 has taken effect, new guidance for in vitro diagnostic (IVD) manufacturers with assays used in clinical trials has been published. Assays...
USA – New rule directs mammography facilities to tell patients about breast density
The US Food and Drug Administration (FDA) has issued a final rule intended to ensure patients are better informed about their breast tissue density...
Europe – MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
The sponsor of a performance study is required to submit an application/notification1 to the Member State(s) in which a performance study is to be...
Europe – Intellectual property: harmonised EU patent rules boost innovation, investment and competitiveness in...
Today, the Commission has proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new...
USA – FDA eases labeling, clarifies IVD requirements in COVID transition guidances
The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to...
China – Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific...
Several new guidelines have been announced by medical device market regulators in China.
First, the Chinese National Medical Product Administration (NMPA) released updates regarding rules...
France – La Société française de dermatologie appelle les autorités à réglementer l’usage de...
PARIS (TICpharma) - La Société française de dermatologie (SFD) et son groupe de télédermatologie et e-santé (Teldes) a appelé les autorités de santé à...
France – Concevoir un dispositif médical conformément à l’ISO 13485:2016
Avant sa mise sur le marché, un dispositif médical passe par de multiples phases de conception. Les premières étapes, dites de faisabilité, consistent à...
Europe – New study shows pioneering test for endometrial cancer could significantly reduce diagnosis...
The pioneering tests, developed by researchers at the University of Innsbruck in Austria and University College London, could mean a significant reduction in the...
