Regulatory Blog

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced (09 May, 2024) the “AI Airlock - The Regulatory Sandbox...

On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices"...

Recently (09 May, 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released the...

Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances...

Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and...

Today (01 May 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance "Regulatory requirements for in-house...

Yesterday (26 April 2024) the UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Notify MHRA About a...

The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Borderlines with Medical Devices & Other Products...

On 3rd April, 2024 Switzerland's Swissmedic released an updated "Guidance on Export Certificates" and as part of its regulatory...

Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...

This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...

Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...

Earlier this week (26 & 29 February 2024) the the U.S. Food and Drug Administration (FDA) released two guidances "Reporting Amount of...

On Monday (19 February, 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance on the "Medical Device...

Today (13 February 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, Center for Devices...

The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit...

FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...

Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...

A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by...