Otsuka ICU Medical LLC has announced a voluntary nationwide recall of a specific lot of potassium…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Critical Labeling Update Issued for Olympus Bronchoscopes Used in Laser Therapy Procedures
Olympus Corporation has announced a voluntary corrective action involving bronchoscopes used in conjunction with certain high-risk…
Swissmedic Opens Bids for Advanced Document and Records Management System: A Regulatory Update
On November 3, 2025, Swissmedic, the Swiss agency for therapeutic products, announced its initiative to procure…
FDA Restricts Sale of Unapproved Fluoride Prescription Drugs for Children’s Safety
The U.S. Food and Drug Administration (FDA) has announced significant regulatory steps to enhance child safety,…
Swissmedic Publishes November Safety Updates for Healthcare Professionals
Swissmedic has issued new safety-related updates this November 2025, designed to inform healthcare professionals and regulatory…
Swissmedic Updates Key Information on Drug Safety Reporting – What You Need to Know
Swissmedic has announced an update to its Drug Safety Reporting Duties in Switzerland information sheet. The…
Swissmedic Updates Signal Management Guidance in PSUR Reporting
Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM…
Urgent Recall Alert: Baxter Healthcare’s Hartmann’s Solution Packaging Mix-up
Baxter Healthcare Limited has issued a Class 2 medicines recall after identifying a packaging error involving…
October 2025 MHRA Safety Bulletin: Critical Updates for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its October 2025 safety update, detailing…
Clinical Teams: Significant Updates on Medical Device Field Safety Notices (20–24 October 2025)
Field Safety Notices (FSNs) issued between 20 and 24 October 2025 have recently been compiled for…