Swissmedic, Switzerland’s medical regulatory authority, has announced an important update regarding NexoBrid®. On November 22, 2025,…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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).…
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…
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…
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…
Attention Clinicians: NOxBOX Ltd. Issues Critical Update for NOxBOXi Nitric Oxide Delivery System Over Dosing Concerns
NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has issued a vital correction for…
Precautionary Recall of Fingolimod SUN 0.5mg by Sun Pharma: Capsule Breakage Risk Emerges
Sun Pharma UK Limited has issued a precautionary recall for one batch of Fingolimod SUN 0.5…
Feedback Requested: Consultation on SaMD ‘Predetermined Change Control Plans’ Closing December 2025
The Software as a Medical Device (SaMD) Working Group has invited stakeholders to review and comment…
Siemens Healthineers Corrects Critical Safety Issue with 3 Tesla MRI Systems
Siemens Healthineers has announced corrective actions for its 3 Tesla MRI systems, addressing a potentially severe…
Critical FDA Alert: Sterile Medline Convenience Kits Recalled Due to Non-Sterilization
Healthcare professionals and supply managers, please be aware of an urgent recall announced by Medline Industries,…