Tag: Medical Devices

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

Medical Device

USA FDA Guidance on Assessing Credibility of Computational Modeling and Simulation The FDA has issued guidance detailing a nine-step framework to assess the credibility of computational modeling...

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

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-Asia and ROW Regulatory News-Oct. 2023

Medical Device

ASIA INDIA The Indian Regulatory Authority (CDSCO) announced List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer...

ANVISA, Asia Regulatory News, Medical Devices, NMPA, Regulatory News, ROW Regulatory News, SaMD, SFDA

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 preparation...

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