Regulatory Blog

The U.S. Food and Drug Administration (FDA) has announced On 30 July 2025 , the official user fee rates across its major healthcare...

The proliferation of Digital Mental Health Technologies (DMHTs) —ranging from self-help apps and online therapy services to artificial...

In July 2025, the USFDA published a revised guidance titled " Medical Device User Fee Small Business Qualification and Determination "...

On 24 July 2025 , the UK Government published the latest update to its official guidance: " Regulation of medical devices in Northern...

The U.S. Food and Drug Administration (FDA)  has launched the " Commissioner’s National Priority Voucher (CNPV) Pilot Program " a...

The efficient international supply of medical devices depends not only on innovation but on robust regulatory processes that certify...

The regulatory landscape for medical devices and digital health technologies in the UK is evolving rapidly, reflecting the growing...

In June 2025, the FDA released two impactful draft guidances that significantly affect medical device and combination product...

On June 19, 2025, the Medical Device Coordination Group (MDCG), in collaboration with the Artificial Intelligence Board (AIB) of the...

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched Phase 2 of its AI Airlock programme , supported by a...

In the ever-evolving landscape of medical device regulation, the Periodic Safety Update Report (PSUR)   plays a pivotal role in ensuring...

In recent years, the MHRA has issued several key guidance documents strengthening the lifecycle safety and regulatory oversight of...

The post-Brexit regulatory landscape for medical devices in the UK has brought significant changes, particularly in Northern Ireland,...

In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “ Transfer of a Premarket Notification...

What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...

As medical technology advances, the FDA’s regulatory frameworks continue evolving to ensure timely, safe, and effective device...

In South Africa, the licensing of medical device establishments is a vital step to ensure compliance with national health regulations and...

As the healthcare industry continues to evolve, the integration of personalised medical devices and companion diagnostics has become...

In a regulatory landscape that continually evolves to ensure public health and safety, the UK Medicines and Healthcare products...

The field of pharmacovigilance (PV) —the science of detecting, assessing, understanding, and preventing adverse effects or any other...