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Sharan Murugan
2 days ago2 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)Â has released Version 3.0Â of its user guide, effective from March 2025, " Completing an...
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Sharan Murugan
2 days ago2 min read
Swissmedic Guidance: Export Certificates for Medical Devices
The Swiss Agency for Therapeutic Products (Swissmedic)Â has introduced updated guidance on " Export Certificates " effective 19 March...
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Sharan Murugan
2 days ago2 min read
MDCG Med Dev: Guidance on Classification Rules for In-Vitro Diagnostic Medical Devices (IVDs)
The Medical Device Coordination Group (MDCG)Â has released the 2020-16 rev.4Â guidance document, " Guidance on Classification Rules for in...
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Sharan Murugan
5 days ago2 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...
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Sharan Murugan
Mar 133 min read
UK Medical Device Regulations: Registration and Export Guidelines
Earlier today the Medicines and Healthcare products Regulatory Agency (MHRA)Â released updated guidance " Register medical devices to...
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Sharan Murugan
Mar 112 min read
TGA Guidance: Consent for Non-Compliant Medical Devices that do not meet the Essential Principles
The Therapeutic Goods Administration (TGA)Â has released updated guidance in "Completing an application for consent to import, supply, or...
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Sharan Murugan
Mar 92 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...
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Sharan Murugan
Mar 12 min read
SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)
The South African Health Products Regulatory Authority (SAHPRA)Â has released an updated " Guideline for the Classification of Medical...
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Sharan Murugan
Feb 182 min read
Navigating UK MHRA Guidance: Registration and Regulation of Medical Devices in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) Â oversees the regulation and registration of medical devices within the...
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Sharan Murugan
Feb 122 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...
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Sharan Murugan
Feb 92 min read
UK MHRA Guidance: Software and AI as a Medical Device
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â updated its guidance on Software and Artificial Intelligence (AI) as a...
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Sharan Murugan
Feb 52 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...
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Sharan Murugan
Feb 13 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)Â has released its final guidance document (IMDRF/AIML WG/N88:2025)Â outlining...
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Sharan Murugan
Jan 263 min read
South Africs's SAHPRA Guidance: on Medical Device Adverse Event Reporting
The South African Health Products Regulatory Authority (SAHPRA)Â has issued comprehensive guidelines to streamline the reporting of...
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Sharan Murugan
Jan 212 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...
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Sharan Murugan
Jan 162 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...
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Sharan Murugan
Jan 162 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...
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Sharan Murugan
Jan 112 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...
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Sharan Murugan
Jan 73 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...
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Sharan Murugan
Jan 72 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...
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