Tag: SaMD

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2025

Medical Device

USA 1. Guidance on: Quality Management System Information for Certain Premarket Submission Reviews The guidance highlights the importance of submission of comprehensive, risk-based QMS documentation...

CDSCO India, EU MDR, FDA guidance, Global Regulatory News, MDA Malaysia, Medical Device Compliance, Medical Device Regulations, QMS, SaMD

Medical Devices – Europe, Asia and ROW Regulatory News – July 2025

Medical Device

BRAZIL Brazil Implements UDI Labeling for Class IV Medical Devices In July, Anvisa marks significant progress in the implementation of Unique Device Identification (UDI) in Brazil, requiring...

AI in Healthcare, EU MDR, HSA Singapore, IVD Devices, Medical Device Regulation, PMDA Japan, PSUR, Regulatory Compliance, SaMD, UDI Brazil

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

ANVISA New Medical Device Regulation RDC 751/2022

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

Medical Device

ASIA MALAYSIA (NPRA) Declaration of Worldwide Registration Status for Generic Medicines Malaysia now requires all new applications for Generic Medicines (Prescription – Full) to include a declaration...

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