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 […]
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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
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
FDA Update: Final Rule Amending the Quality System Regulation
The FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS)
MHRA Update: Roadmap towards the future regulatory framework for medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its regulatory roadmap for the development of new and robust
Update: Australian Clinical Evidence Guidelines for Medical Devices
In November 2023 Australia’s regulatory board, Therapeutic Goods Administration (TGA) released a revision of the Clinical Evidence Guideline Version 3.2.
Revolutionising Medical Device Industry: The Impact of Digital Transformation on Quality Assurance and Regulatory Compliance
In the dynamic and highly regulated medical device industry, digital transformation is not just a buzzword but a fundamental shift
Own Brand Labelling- The Ins and Outs
Own Brand Labelling (OBL) in the medical device industry was a term used to define companies that market and sell
India postpones the implementation of licensing requirements for higher-risk medical devices.
In 2020, India outlined plans to revamp the regulatory framework for medical devices adopting a phased approach. While manufacturers of