The New EU AI Act and MHRA’s Role: What It Means for the Medical Device Industry
The European Union’s AI Act, set for full implementation by 2024, introduces a groundbreaking regulatory framework that will significantly impact […]
China’s NMPA Implements New Medical Device Classification Rules – What This Means for Global Manufacturers
News: As of September 1, 2024, China’s National Medical Products Administration (NMPA) will enforce new classification rules for medical devices.
FDA Releases New Guidelines for Electronic Medical Device User Manuals: What You Need to Know
In a significant move towards modernization, the U.S. Food and Drug Administration (FDA) has issued new guidance allowing medical device
Understanding Field Safety Notices and Medical Device Recalls for Compliance
In the healthcare industry, ensuring the safety and effectiveness of medical devices is paramount. When issues arise that might compromise
European Commission Proposes New Standards for High-Risk Diagnostic Devices Targeting Parasites and Viruses
The European Commission’s proposal for new common specifications for certain high-risk in vitro diagnostic devices (IVDs) reflects an ongoing effort
Understanding Labelling Requirements MDR: A Complete Overview
The Medical Device Regulation (MDR) introduced by the European Union (EU) marks a significant overhaul in the regulation of medical
Understanding the Medical Device Technical File | Structure of Technical File under the Medical Device Regulation (MDR)
The aim of this document is to demystify the concept and purpose of a technical file as required under the
The Australian TGA Medical Device Regulations: A Comprehensive Guide
Entering the Australian market with a medical device requires a thorough understanding of the regulations set by the Therapeutic Goods
Exploring Medical Device Vigilance Definition and Incident Reporting in Europe
As we look into medical devices within the European Union, Medical Device Vigilance and incident reporting represent critical facets of
Understanding the Role of the EU Authorised Representative in Medical Device Compliance
Understanding the complexities of regulatory compliance is essential for medical device manufacturers aiming to enter or maintain their presence in