Regulatory Blog

With the regulatory landscape evolving in the UK post-Brexit, manufacturers, importers, distributors and authorised representatives must be fully aligned with the registration requirements laid out by the MHRA. The guidance titled “ Register medical devices to place on the market ”  sets out the detailed steps, legal framework, responsibilities and timelines you must meet for compliant market entry. Under the guidance, every medical device  (including in-vitro diagnostics (IV

The Philippines FDA ("FDA Philippines") continues to enhance its regulatory frameworks to streamline processes and align with international best practices. Three recent draft guidelines open for public comments address critical areas impacting pharmaceutical products and medical devices for comment: Implementing Guidelines on the Post-Approval Changes of Registered Pharmaceutical Products for Human Use   (for human medicines) Guidelines on the Application for Variation of the

The U.S. Food and Drug Administration (FDA) has recently released two significant draft guidance  documents that mark important steps forward in the modernization and harmonization of medical device regulations: Quality Management System (QMS) Information for Certain Premarket Submission Reviews Menstrual Products – Performance Testing and Labeling Recommendations Both are designed to increase transparency, strengthen product safety and quality, and align FDA’s approach with

In October 2025, the European Medicines Agency (EMA) released two landmark drafts for public consultation. These documents collectively signal the Agency’s evolving regulatory stance toward precision biologics such as bacteriophage therapy and innovative device–drug integration approaches to simplify clinical bridging for biologics delivered subcutaneously. 1. Quality Guidance for Phage Therapy Medicinal Products (PTMPs) The EMA draft guideline on phage therapy quality (Oct

The UK’s post-Brexit regulatory landscape for medical devices continues to evolve, placing renewed emphasis on safety, performance, and transparency. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued clear guidance on both registering medical devices for market access and conducting clinical investigations, ensuring compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002) and the Windsor Framework. This combined overview summarizes the lat

The U.S. Food and Drug Administration (FDA) has finalized a pivotal guidance  addressing how the agency will decide when to begin and end...

On 25 September 2025 , the U.S. Food and Drug Administration (FDA) highlighted four critical updated or reaffirmed guidances  spanning...

The UK’s Medicines and Healthcare products Regulatory Agency ( MHRA ) has issued a coordinated update to its suite of clinical trial...

The Medicines and Healthcare products Regulatory Agency (MHRA) provides a detailed framework for conducting clinical investigations of...

Digital health is no longer just an emerging trend—it is rapidly transforming healthcare delivery, patient engagement, and medical...

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in regulating medicines, medical devices, and related...

Artificial Intelligence (AI) and Machine Learning (ML) are transforming healthcare globally, offering powerful tools for diagnosis,...

On 22 August 2025 , the U.S. Food and Drug Administration (FDA) released a comprehensive guidance document titled “ Animal Studies for...

On 22 August 2025 , the Medicines and Healthcare products Regulatory Agency (MHRA) published an updated version of its guidance “...

Artificial Intelligence and Machine Learning (AI/ML) are increasingly used in medical devices—from diagnostic imaging software to digital...

The Medical Device Authority (MDA) of Malaysia has officially launched the Malaysia–China Medical Device Regulatory Reliance Programme ,...

On 8 August 2025,  the European Commission  released an in-depth study on the " Deployment of artificial intelligence (AI)  in healthcare...

Medical devices, whether diagnostic, therapeutic, or assistive, undergo rigorous scrutiny before entering the UK market. One of the most...

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...