Tag: Medical Device Regulations

Medical Devices – Europe, UK and Asia Regulatory News – April 2025

May 13, 2025
Medical Device

FINLAND Manufacturer of in vitro diagnostic medical devices – ensure the use of the extended transition period The European Commission has issued a reminder to manufacturers of in vitro diagnostic...

Asia Medical Device Regulations, CDSCO Medical Devices India, EMA Orphan Device Guidance, European Medical Device Updates, Global Medical Device Compliance, IVDR Compliance 2025, Medical Device News April 2025, Medical Device Regulations, MHRA Medical Device Guidance, UK Medical Device Market Access

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

April 8, 2025
Medical Device

USA Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff This guidance document, issued by the FDA, focuses...

EU Regulations, Global Med Tech, Healthcare Compliance, MDR Update, Med Tech News, Medical Device News, Medical Device Regulations, Medical Devices 2025, Regulatory Affairs, Regulatory Update

Regulatory Intelligence Database, Software & Tools for Compliance

March 19, 2025
Regulatory Intelligence

What is Regulatory Intelligence? Regulatory Intelligence (RI) is the process of collecting, analysing, and interpreting regulatory information to help organizations comply with legal and industry...

Compliance Software, Medical Device Regulations, Pharma Compliance, Reg Tech, Regulatory Affairs, Regulatory Compliance, Regulatory Intelligence, Regulatory Technology, Regulatory Updates

2024 Recap: Medical Device key Regulation/Guidance in USA, EU, Asia and ROW

December 16, 2024
Medical Device

USA EUROPE AUSTRALIA BRAZIL CANADA CHINA COLUMBIA CZECH-REPUBLIC FINLAND FRANCE GERMANY HONG-KONG HUNGARY ICELAND INDIA IRELAND ...

Asia, Device Compliance, EU, Global Health Healthcare Standards, Global Trends, Guidance, Health Tech, IVDR, MDR, Med Tech, Medical Device Regulations, Medical Devices, Medical Innovation, Regulations, Regulatory Compliance, Regulatory Updates, ROW, USA

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