Tag: Medical Device Regulation

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

August 5, 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 Device Regulatory Challenges & Solutions | Expert Insights

September 13, 2024
Medical Device

Medical devices must meet stringent regulatory requirements to ensure safety and efficacy. These regulations are crucial but can also be complex and challenging for companies. Understanding and addressing...

Compliance Services, Device Compliance, Global Regulations, Medical Device Regulation, Regulatory Challenges, Regulatory Experts, Regulatory Solutions, Regulatory Strategy, Regulatory Updates

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 Device Labelling Requirements

February 13, 2023
Medical Device

The safe operation of a medical device must never come down to guesswork or trial and error. Informative, accurate labeling is required, and every label included with the device has to meet the applicable...

Code of Federal Regulations, EU MDR, General Device Labeling, In Vitro Diagnostic, Medical Device Labelling, Medical Device Regulation, Unique Device Identification, US FDA