Category: Medical Device

Challenges, Benefits, and Future Trends in Compliance Intelligence

November 9, 2023
Medical Device

Regulatory compliance, also known as business compliance, pertains to an organization’s adherence to the laws, regulations, and other governing rules applicable to all entities. By utilizing...

Compliance Intelligence, Medical Device Industry. Compliance Intelligence, Regulatory Compliance

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

Swissmedic Device/IVD Database Key Dates

November 3, 2023
Medical Device

Swissmedic now handles registration of economic operators, medical devices and in vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments...

IVD Regulations, Medical Device Compliance, Medical Device Manufacturers, Regulatory Updates, Swissmedic

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

October 18, 2023
Medical Device

ASIA INDIA The Indian Regulatory Authority (CDSCO) has released 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

October 5, 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