Search
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 22, 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 22, 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
UK MHRA: Guidance on Regulation and Licensing of Advanced Therapy Medicinal Products (ATMPs) in the UK
To legally sell or supply an Advanced Therapy Medicinal Product (ATMP) in the United Kingdom, you must obtain a marketing authorisation...
Sharan Murugan
Mar 9, 20252 min read
SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)
The South African Health Products Regulatory Authority (SAHPRA) has released an updated " Guideline for the Classification of Medical...
Sharan Murugan
Mar 1, 20252 min read
Navigating UK MHRA Guidance: Registration and Regulation of Medical Devices in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) oversees the regulation and registration of medical devices within the...
Sharan Murugan
Feb 18, 20252 min read
EMA Announcement: Regular Scientific Advice Procedure for High-Risk Medical Devices
In collaboration with the European Commission, the European Medicines Agency (EMA) has launched (10 February 2025) a regular...
Sharan Murugan
Feb 12, 20252 min read
UK MHRA Guidance: Software and AI as a Medical Device
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Software and Artificial Intelligence (AI) as a...
Sharan Murugan
Feb 9, 20252 min read
USFDA Guidance: Institutional Review Board (IRB) Written Procedures
Institutional Review Boards (IRBs) play a crucial role in safeguarding the rights and welfare of human research subjects. To enhance...
Sharan Murugan
Feb 5, 20252 min read
IMDRF Med Dev Guidance: Good Machine Learning Practice (GMLP) for Medical Device Development: IMDRF’s Guiding Principles
The International Medical Device Regulators Forum (IMDRF) has released its final guidance document (IMDRF/AIML WG/N88:2025) outlining...
Sharan Murugan
Feb 1, 20253 min read
South Africs's SAHPRA Guidance: on Medical Device Adverse Event Reporting
The South African Health Products Regulatory Authority (SAHPRA) has issued comprehensive guidelines to streamline the reporting of...
Sharan Murugan
Jan 26, 20253 min read