Regulatory Blog

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In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “ Transfer of a Premarket Notification...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

In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...

Before starting any clinical investigation involving a medical device in the UK, it is a legal requirement to notify the Medicines and...

The International Medical Device Regulators Forum (IMDRF) has released the fifth edition of its guidance titled “ Medical Devices:...

The South African Health Products Regulatory Authority (SAHPRA) has updated its Guideline " Section 21 Access to Unregistered Medicines "...

In March 2025, the U.S. Food and Drug Administration (FDA) released a final guidance titled “ Evaluation of Sex-Specific Data in Medical...

The Medical Device Authority (MDA) of Malaysia has released two important guidance documents, " Guide for Conformity Assessment Bodies...