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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
Feb 28, 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
UK MHRA Guidance: Strengthening Post-Market Surveillance for Medical Devices
On 15 January, the Medicines and Healthcare products Regulatory Agency (MHRA) released a suite of guidance outlining the new PMS...
Sharan Murugan
Jan 21, 20252 min read
UK MHRA Med Dev Guidance: Applying Human Factors to Medical Devices
The Medicines and Healthcare Products Regulatory Agency (MHRA) published its comprehensive guidance titled “ Applying Human Factors and...
Sharan Murugan
Jan 16, 20252 min read
USFDA Med Dev Guidance: Premarket Approval Application and Humanitarian Device Exemption Modular Review
The U.S. Food and Drug Administration (FDA) released final guidance " Premarket Approval Application and Humanitarian Device Exemption...
Sharan Murugan
Jan 16, 20252 min read
USFDA Guidance: Developing Drugs for Optical Imaging – A Comprehensive Insight
On 07 January 2025, the U.S. Food and Drug Administration (FDA) released the draft guidance titled " Developing Drugs for Optical Imaging...
Sharan Murugan
Jan 11, 20252 min read
USFDA Guidance Updates: A Comprehensive Look at Recent Policies and Draft Recommendations
The U.S. Food and Drug Administration (FDA) has recently issued several key guidance documents addressing critical areas in...
Sharan Murugan
Jan 7, 20253 min read
USFDA Guidance: Artificial Intelligence-Enabled Device Software Functions – Lifecycle Management and Marketing Submission Recommendations
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “ Artificial Intelligence-Enabled Device Software...
Sharan Murugan
Jan 7, 20252 min read
USFDA Guidance: Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...
Sharan Murugan
Dec 28, 20242 min read
USFDA Guidance: Global Unique Device Identification Database (GUDID): Enhancing Medical Device Transparency
The U.S. Food and Drug Administration (FDA) has updated and released its " Global Unique Device Identification Database (GUDID) " final...
Sharan Murugan
Dec 21, 20242 min read
SAHPRA's: Guidelines for Medical Device Adverse Event Reporting
The South African Health Products Regulatory Authority (SAHPRA) has released two crucial guidelines to streamline adverse event reporting...
Sharan Murugan
Dec 15, 20242 min read
TGA: Australian Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) , issued by the Therapeutic Goods Administration (TGA), provide a...
Sharan Murugan
Dec 15, 20242 min read
USFDA Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
The US Food and Drug Administration (USFDA) has issued its final guidance on " Marketing Submission Recommendations for a Predetermined...
Sharan Murugan
Dec 9, 20242 min read
USFDA Guidance: Enhancing Communication and Guidance Development Practices
The US Food and Drug Administration (USFDA) has released two insightful reports aimed at improving its internal practices and...
Sharan Murugan
Dec 4, 20242 min read