Regulatory Blog

Conducting clinical investigations for medical devices in the UK requires strict adherence to MHRA’s updated regulatory framework, designed to support patient safety, device innovation, and compliance with evolving UK (and EU for Northern Ireland) requirements. The guidance  “ Notify MHRA about a clinical investigation for a medical device ” provides a clear roadmap for manufacturers, sponsors, and investigators who plan to conduct clinical investigations of medical devices i

The U.S. Food and Drug Administration (FDA) has released its updated guidance “ How to Prepare a Pre-Request for Designation (Pre-RFD) ” , issued on November 6, 2025 . This guidance provides companies with a clear roadmap for obtaining early, non-binding feedback on the regulatory classification of their products — especially combination products , which often sit at the intersection of drugs, devices and biologics. The updated guidance strengthens transparency, clarifies ex

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The U.S. Food and Drug Administration (FDA) has recently released two significant draft guidance  documents that mark important steps forward in the modernization and harmonization of medical device regulations: Quality Management System (QMS) Information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 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 proliferation of Digital Mental Health Technologies (DMHTs) —ranging from self-help apps and online therapy services to artificial...