Critical Updates: Field Safety Notices Issued from 10–14 November 2025
Between 10 and 14 November 2025, significant Field Safety Notices (FSNs) were announced, carrying potential implications for stakeholders across clinical,…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Latest News
FDA Issues Critical Recall Alert for Intersurgical i-View Video Laryngoscopes
On November 22, 2025, the FDA released details regarding a significant recall of the i-View Video Laryngoscope, manufactured by Intersurgical…
Latest News
Critical Update: Revised Instructions for Flexicare BritePro Solo Devices in Medline Kits
Medline Industries, LP has issued an urgent revision to the use instructions for Medline medical convenience kits containing the Flexicare…
Europe
Swissmedic Confirms First Authorisation for Lutathera®: Key Regulatory Update
On November 22, 2025, Swissmedic published an important regulatory update announcing the first authorisation of Lutathera®, a therapeutic option designed…
Europe
Swissmedic Expands Use of Breyanzi®: Updated Authorization Details
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel). This change has important…
Europe
Swissmedic Authorizes 18F-PSMA-1007 ZRP®: Key Insights for Regulatory and Clinical Teams
On November 22, 2025, Swissmedic officially granted the first authorization of 18F-PSMA-1007 ZRP®. This approval represents an important milestone in…
Europe
Swissmedic Grants First Authorisation of Radelumin®: A Regulatory Milestone
Swissmedic has announced the first authorisation of Radelumin®, marking a significant regulatory achievement. Effective November 22, 2025, this authorisation introduces…
Europe
Swissmedic Update: Expanded Indication Approval for NexoBrid®
Swissmedic, Switzerland’s medical regulatory authority, has announced an important update regarding NexoBrid®. On November 22, 2025, Swissmedic extended the therapeutic…
Europe
Swissmedic Issues DHPC for DIBASE® 10’000 to Address Handling Errors
On November 22, 2025, Swissmedic released a Direct Healthcare Professional Communication (DHPC) concerning DIBASE® 10’000 (cholecalciferolum). This announcement highlights crucial…
Canada
Health Canada Releases Updated Guidance on Medical Device License Applications
Health Canada has published updated guidelines for managing medical device license applications. These regulations aim to enhance clarity for manufacturers,…
Latest News
Critical Alert: FDA Revises Usage Guidelines for B Braun Hemodialysis Blood Tubing Set
The U.S. Food and Drug Administration has issued an urgent notice regarding the updated instructions for the use of the…
Latest News
Critical Safety Update: NOxBOXi Nitric Oxide Delivery System Correction for Rapid Command Input Issue
NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has announced a critical correction for its NOxBOXi Nitric Oxide…
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