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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
EMA Network Data Steering Group workplan 2025-2028: Leveraging Data and AI for Enhanced Medicine Regulation
In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...
Sharan Murugan
May 11, 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
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
Australia (TGA) Med Dev User Guide: Completing an Application for Consent to Import, Supply, or Export a Medical Device That Does Not Meet the Essential Principles
The Therapeutic Goods Administration (TGA) has released Version 3.0 of its user guide, effective from March 2025, " Completing an...
Sharan Murugan
Mar 21, 20252 min read
Swissmedic Guidance: Export Certificates for Medical Devices
The Swiss Agency for Therapeutic Products (Swissmedic) has introduced updated guidance on " Export Certificates " effective 19 March...
Sharan Murugan
Mar 21, 20252 min read
MDCG Med Dev: Guidance on Classification Rules for In-Vitro Diagnostic Medical Devices (IVDs)
The Medical Device Coordination Group (MDCG) has released the 2020-16 rev.4 guidance document, " Guidance on Classification Rules for in...
Sharan Murugan
Mar 21, 20252 min read
Malaysia MDA Med Dev Guidance: Importation of Medical Devices for Re-Export (IRE)
The Medical Device Authority (MDA) of Malaysia, under the Ministry of Health, has introduced a guidance " Importation of Medical Devices...
Sharan Murugan
Mar 18, 20252 min read
UK Medical Device Regulations: Registration and Export Guidelines
Earlier today the Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance " Register medical devices to...
Sharan Murugan
Mar 13, 20253 min read
TGA Guidance: Consent for Non-Compliant Medical Devices that do not meet the Essential Principles
The Therapeutic Goods Administration (TGA) has released updated guidance in "Completing an application for consent to import, supply, or...
Sharan Murugan
Mar 11, 20252 min read