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The U.S. Food and Drug Administration (FDA) has recently released two significant draft guidance  documents that mark important steps forward in the modernization and harmonization of medical device regulations: Quality Management System (QMS) Information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