Tag: Medical Devices

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

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-Asia and ROW Regulatory News-Nov. 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 of...

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

Modifications to Medical Device Registration in Mexico

Medical Device

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

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

Medical Devices-USA/Europe Regulatory News – Nov 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

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with...

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

Medical Devices-USA/Europe Regulatory News-September 2023

Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The FDA has released guidance designed to support institutional review boards (IRBs), clinical investigators,...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance

Tag: Medical Devices

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

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

Modifications to Medical Device Registration in Mexico

Medical Devices-USA/Europe Regulatory News – Nov 2023

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Devices-USA/Europe Regulatory News-September 2023

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