Tag: SaMD

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

ANVISA New Medical Device Regulation RDC 751/2022

June 27, 2023
Medical Device

On March 1st, 2023, the new RDC (Resolution of the Collegiate Board) 751/2022 released by the Brazilian National Health Surveillance Agency (ANVISA) went into force. The fundamental goal of the...

ANVISA, Brazil Healthcare, Compliance Standards, EU MDR Regulation, Medical Device Regulation, RDC751, SaMD

Medical Devices-Asia and ROW Regulatory News – April 2023

April 18, 2023
Medical Device

ASIA INDIA (CDSCO) Circular for Licensing of Class C & D medical devices According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, SaMD, Software as a Medical Device