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UK MHRA Med Dev Guidance: Clinical Investigations for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA)Â provides a detailed framework for conducting clinical investigations of...
Sharan Murugan
Sep 72 min read
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Saudi Arabia (SFDA) New Guidance: On Digital Health Products
Digital health is no longer just an emerging trend—it is rapidly transforming healthcare delivery, patient engagement, and medical...
Sharan Murugan
Sep 43 min read
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UK MHRA Guidance: Navigating New MHRA Payments & Fees guidance
The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in regulating medicines, medical devices, and related...
Sharan Murugan
Sep 43 min read
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SAHPRA Communication: Regulatory Requirements for AI/ML-Enabled Medical Devices in South Africa
Artificial Intelligence (AI) and Machine Learning (ML) are transforming healthcare globally, offering powerful tools for diagnosis,...
Sharan Murugan
Aug 232 min read
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USFDA Med Dev Guidance: Animal Studies for Dental Bone Grafting Material Devices in 510(k) Submissions
On 22 August 2025 , the U.S. Food and Drug Administration (FDA) released a comprehensive guidance document titled “ Animal Studies for...
Sharan Murugan
Aug 232 min read
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