Swissmedic issues a patient-centric recall for specific batches of Algifor Junior Suspension 200 ml and Algifor…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Swissmedic Announces New Therapeutic Indication for Tepkinly®
Swissmedic has announced an update to the therapeutic indications for Tepkinly®. This regulatory approval marks an…
Swissmedic Approves Enhertu® for Extended Therapeutic Indications
Swissmedic has granted authorization for the extension of therapeutic indications for Enhertu® as of November 28,…
Temporary Authorization Alert: Ringerfundin B. Braun Infusion Solution Distribution Update
Swissmedic, the Swiss Agency for Therapeutic Products, has granted a temporary approval for the distribution of…
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Urgent Swissmedic Recall: Specific Batch of Azelastin-Fluticason-Mepha Nasal Spray Withdrawn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…