Regulatory Blog

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In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “ Transfer of a Premarket Notification...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

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...

The European Medicines Agency (EMA) has unveiled a comprehensive Artificial Intelligence (AI) Work Plan  to guide the integration of AI...

The U.S. Food and Drug Administration (FDA) has released the latest version (v6.0) of the Study Data Technical Conformance Guide in...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...

The Therapeutic Goods Administration (TGA) has released Version 3.0 of its user guide, effective from March 2025, " Completing an...

The Swiss Agency for Therapeutic Products (Swissmedic) has introduced updated guidance on " Export Certificates " effective 19 March...

The Medical Device Coordination Group (MDCG) has released the 2020-16 rev.4 guidance document, " Guidance on Classification Rules for in...

The Medical Device Authority (MDA) of Malaysia, under the Ministry of Health, has introduced a guidance " Importation of Medical Devices...