Swissmedic, the Swiss Agency for Therapeutic Products, has granted a temporary approval for the distribution of…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Swissmedic Spotlights Personnel Roles: Essential Update for Teams
On November 28, 2025, Swissmedic released details regarding changes in personnel requirements within its Abteilung Personal…
Swissmedic Announces HR Business Partner Opening: A Strategic Role in Regulatory Support
Swissmedic, the Swiss Agency for Therapeutic Products, has announced an exciting job opportunity for an HR…
Temporary Authorization for Ringerlactat B. Braun Infusion Solution in German Packaging
Swissmedic announces a temporary distribution authorization for Ringerlactat B. Braun Infusion Solution packaged in German labeling.…
Swissmedic Opens Access to Swissdamed UDI Devices Playground
Swissmedic has announced the release of the Swissdamed UDI Devices Playground, an online tool designed to…
Urgent Swissmedic Recall: Specific Batch of Azelastin-Fluticason-Mepha Nasal Spray Withdrawn
On November 27, 2025, Swissmedic announced an immediate recall of batch number 100062289 of Azelastin-Fluticason-Mepha Nasal…
Critical Recall Alert: Baxter Removes Life2000 Ventilator System Over Cybersecurity Risks
The FDA has announced a Class I recall for Baxter’s Life2000 Ventilation System, citing serious potential…
FDA Issues Urgent Recall of Mega Ballast Medical Devices Due to Serious Health Risks
The FDA has flagged a critical recall concerning Balt USA’s Mega Ballast Distal Access Platform devices,…
Urgent Swissmedic Batch Recall: Lexotanil 3mg Tablets
On 26 November 2025, Swissmedic issued an official notice regarding the immediate recall of batch 1653102…
Swissmedic Grants Initial Authorisation for Tepezza®: Key Implications for Regulatory Teams
Swissmedic announces the first authorisation of Tepezza®. This development is significant for quality, clinical, and regulatory…