Regulatory Affairs

Global updates on medical device regulation and quality.

441 articles
Home / Regulatory Affairs
441 articles in Regulatory Affairs
Europe

Swissmedic Updates Guidelines on Professional Advertising at Events with Patient Representatives

Swissmedic has announced a significant update regarding professional advertising practices during medical education events, particularly those attended by patient organization…

Europe

Safety Update: Key Field Notices Issued in Early October 2025

Between 29 September and 3 October 2025, critical updates were released regarding medical device safety compliance. These Field Safety Notices…

Europe

Swissmedic Advisory: Safety Update for Tegretol 2% Oral Suspension Containing Propylene Glycol

Swissmedic has issued an important safety advisory regarding Tegretol 2% oral suspension, which contains propylene glycol. This announcement highlights updated…

Europe

Swissmedic Issues Recall of Maprelin Veterinary Injection for Pigs: Key Details for Healthcare Teams

On October 7, 2025, Swissmedic announced a recall of specific batches of the veterinary medicinal product Maprelin ad us. vet.…

Europe

Swissmedic Announces Immediate Recall of Multiple Gonavet Veyx Veterinary Medicine Batches

Swissmedic has issued an urgent recall of several batches of the veterinary medicine Gonavet Veyx ad us. vet., an injectable…

Europe

BD BodyComm™ Update: Critical Transition Guidance for Infusion Pumps Ahead of Windows 11 Migration

On October 6, 2025, an important update concerning BD BodyComm™ software was announced. Designed to manage BodyGuard infusion pumps, BodyGuard-T…

Europe

Swissmedic September Journal: Key Updates for Regulatory and Quality Teams

Swissmedic, Switzerland’s authority for therapeutic products, has released its latest journal for September 2025. The publication addresses updates pivotal to…

Europe

GHWP Announces Voluntary Exit from IMDRF Membership

On June 24, 2025, the Global Harmonization Working Party (GHWP) officially stepped down as a member of the International Medical…

Europe

Swissmedic Highlights New Adverse Effect for Neptra Veterinary Eardrops

Swissmedic has issued an important update regarding Neptra eardrops for veterinary use in dogs, emphasizing a newly identified adverse effect…

Europe

Regulatory Update: Temporary Approval for Betaseptic Alcoholic Povidone-Iod Solution 1000 ml in Austria

Swissmedic has announced the temporary authorization for the distribution of Betaseptic Alcoholic Povidone-Iod Solution 1000 ml in Austrian packaging. This…

Europe

Swissmedic Announces Urgent Recall of Veterinary Medicine Buserol Across Multiple Batches

Swissmedic has issued a recall notice for specific batches of the veterinary injectable solution Buserol. The affected batches are 24D167,…

Europe

Critical Batch Recall of Spersallerg SDU 20 Single-Dose Units: Swissmedic Notification

Swissmedic has issued an official recall for specific batches of Spersallerg SDU 20 monodose eye drops. This recall applies to…

Loading more articles…
Scroll to Top