Tag: Medical Devices

Medical Devices – Europe, Asia and ROW Regulatory News – Feb. 2024

March 5, 2024
Medical Device

EUROPE Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices The Commission, after consulting the Member States in...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

Recap 2023 : Key Medical Device Regulatory highlights in Asia and ROW

January 31, 2024
Medical Device

ASIA CHINA Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligence software for magnetic...

Healthcare Compliance, Medical Devices, Regulatory Updates

Medical Devices – USA/Europe Regulatory News – Dec. 2023

December 6, 2023
Medical Device

USA Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance describes a nine-step framework...

Clinical Trial, Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-Asia and ROW Regulatory News-Nov. 2023

November 28, 2023
Medical Device

ASIA CHINA NMPA released Guidance Draft for comments on 54 guiding principles for registration review of Class II medical devices including the “Guiding Principles for Registration Review...

Asia Regulatory News, Clinical Evaluation, Medical Devices, Regulatory News, ROW Regulatory News

Modifications to Medical Device Registration in Mexico

November 8, 2023
Medical Device

In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, updated the Guidance Document by defining types and impact of product or organizational changes...

COFEPRIS, Medical Device Regulations, Medical Devices, Mexico, Regulatory Guidelines

Medical Devices-USA/Europe Regulatory News – Nov 2023

November 7, 2023
Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News