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USFDA Guidance: Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis and Reduce the Risk of Transmission of Mycobacterium tuberculosis
The U.S. Food and Drug Administration (USFDA) has released two important guidance documents addressing the risks of sepsis and...
Sharan Murugan
Feb 13 min read
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UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has issued several guidance documents detailing the licensing,...
Sharan Murugan
Feb 13 min read
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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...
Sharan Murugan
Feb 13 min read
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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...
Sharan Murugan
Jan 263 min read
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South Africs's SAHPRA Communication: Regulatory Information Management System – Application Withdrawal
The South African Health Products Regulatory Authority (SAHPRA)Â has issued a Communication to the industry on the process for the...
Sharan Murugan
Jan 262 min read
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