Tag: Medical Device Regulations

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Aug 2024

September 4, 2024
Medical Device

USA Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers The VMSR (Voluntary Malfunction Summary Reporting) Program allows device manufacturers to report certain device...

Asia Regulations, Europe Regulations, Global Compliance, Global Regulatory Updates, Healthcare Regulations, Medical Device Regulations, Medical Devices, Regulatory Updates, USA Regulations

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

What Pharma Companies need to know about EU MDR Regulations?

July 6, 2023
Biopharma

EU MDR The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices The EU MDR entered into application on 26 May 2021 REGULATION...

Compliance, EU MDR, Medical Device Regulations, Pharmaceutical Industry, Regulatory Affairs