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MDCG Med Dev Guidance: Interplay between MDR & IVDR and the Artificial Intelligence Act
On June 19, 2025, the Medical Device Coordination Group (MDCG), in collaboration with the Artificial Intelligence Board (AIB) of the...
Sharan Murugan
Jun 28, 20253 min read
UK MHRA News: "AI Airlock" Pioneering Safe Healthcare Innovation in the UK
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched Phase 2 of its AI Airlock programme , supported by a...
Sharan Murugan
Jun 23, 20252 min read
UK MHRA Guidances: Strengthening Device Oversight: Periodic Safety Update Reports (PSURs) for Medical Devices
In the ever-evolving landscape of medical device regulation, the Periodic Safety Update Report (PSUR) plays a pivotal role in ensuring...
Sharan Murugan
Jun 18, 20253 min read
UK MHRA Guidances: Ensuring Medical Device Safety in Great Britain: Field Safety Notices, Post-Market Surveillance, and Custom-Made Devices
In recent years, the MHRA has issued several key guidance documents strengthening the lifecycle safety and regulatory oversight of...
Sharan Murugan
Jun 18, 20253 min read
UK MHRA Guidance: Regulation of Medical Devices in Northern Ireland: What You Need to Know in 2025
The post-Brexit regulatory landscape for medical devices in the UK has brought significant changes, particularly in Northern Ireland,...
Sharan Murugan
Jun 13, 20252 min read
USFDA Draft Med.Dev Q&A: Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers
In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “ Transfer of a Premarket Notification...
Sharan Murugan
Jun 7, 20252 min read
Meet ELSA: USFDA Launches Agency-Wide AI Tool to Optimize Performance
What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...
Sharan Murugan
Jun 2, 20252 min read
USFDA’s Med Dev Guidance: The Q-Submission Program & Electronic Submission Template for Medical Device Q-Submissions
As medical technology advances, the FDA’s regulatory frameworks continue evolving to ensure timely, safe, and effective device...
Sharan Murugan
May 30, 20252 min read
South Africa SAHPRA's Med Dev Guidance: Updated Q&A-Guide to Licensing Medical Device Establishments
In South Africa, the licensing of medical device establishments is a vital step to ensure compliance with national health regulations and...
Sharan Murugan
May 24, 20252 min read
Australia TGA's Guidance: Regulatory Landscape for Personalised Medical Devices and Companion Diagnostics
As the healthcare industry continues to evolve, the integration of personalised medical devices and companion diagnostics has become...
Sharan Murugan
May 24, 20253 min read
UK MHRA’s MORE System: Enhancing Post-Market Surveillance of Medical Devices
In a regulatory landscape that continually evolves to ensure public health and safety, the UK Medicines and Healthcare products...
Sharan Murugan
May 17, 20253 min read
CIOMS Working Group Draft Report: Artificial Intelligence in Pharmacovigilance: Key Takeaways
The field of pharmacovigilance (PV) —the science of detecting, assessing, understanding, and preventing adverse effects or any other...
Sharan Murugan
May 13, 20253 min read
UK MHRA Guidance: How to Notify a Clinical Investigation for a Medical Device & CTR Signed to Law
Before starting any clinical investigation involving a medical device in the UK, it is a legal requirement to notify the Medicines and...
Sharan Murugan
Apr 18, 20253 min read
Medical Devices: Post-Market Surveillance – Global NCAR Exchange Simplified
The International Medical Device Regulators Forum (IMDRF) has released the fifth edition of its guidance titled “ Medical Devices:...
Sharan Murugan
Apr 8, 20252 min read
SAHPRA Guideline: Section 21 Access to Unregistered Medicines
The South African Health Products Regulatory Authority (SAHPRA) has updated its Guideline " Section 21 Access to Unregistered Medicines "...
Sharan Murugan
Apr 6, 20253 min read
USFDA Guidance: Evaluation of Sex-Specific Data in Medical Device Clinical Studies (March 2025)
In March 2025, the U.S. Food and Drug Administration (FDA) released a final guidance titled “ Evaluation of Sex-Specific Data in Medical...
Sharan Murugan
Apr 5, 20252 min read
Malaysia MDA Med Dev Guidance: Guide for CABs and Medical Device Establishments
The Medical Device Authority (MDA) of Malaysia has released two important guidance documents, " Guide for Conformity Assessment Bodies...
Sharan Murugan
Apr 1, 20253 min read
EMA's New AI Work Plan: Shaping the Future of Medicines Regulation
The European Medicines Agency (EMA) has unveiled a comprehensive Artificial Intelligence (AI) Work Plan to guide the integration of AI...
Sharan Murugan
Mar 31, 20252 min read
USFDA Guidance: Study Data Technical Conformance Guide – Technical Specifications Document and Data Standards Catalog
The U.S. Food and Drug Administration (FDA) has released the latest version (v6.0) of the Study Data Technical Conformance Guide in...
Sharan Murugan
Mar 30, 20253 min read
UK MHRA Guidance: Blue Guide -Advertising and Promoting Medicines – A Regulatory Overview
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...
Sharan Murugan
Mar 30, 20252 min read