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UK MHRA Med. Dev Guidance: Clinical Investigations in the UK: When & How to Notify MHRA
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
Sharan Murugan
Nov 152 min read
Swissmedic’s Guidance: Packaging, Prior Notification Procedures, Fast-Track Authorisation, Regulatory Meetings & Temporary Authorisations
Swissmedic, the Swiss Agency for Therapeutic Products, has released multiple updated guidance documents in April 2025 that impact...
Sharan Murugan
Apr 62 min read
UK MHRA Issues Final Call to Comply with Windsor Framework for Medicines by January 2025
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued " Call to comply with Windsor Framework arrangements for...
Sharan Murugan
Nov 29, 20242 min read
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...
Sharan Murugan
Mar 20, 20242 min read
USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"
Yesterday (06 February 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
Feb 7, 20242 min read