FDA Issues Serious Correction Notification for BD Alaris Pump Modules Due to Safety Risks
The United States Food and Drug Administration (FDA) has released an updated correction notification for BD Alaris pump modules. These…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Latest News
Europe
Important Patient-Level Recall: Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200 ml
Swissmedic issues a patient-centric recall for specific batches of Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200…
Europe
Swissmedic Announces New Therapeutic Indication for Tepkinly®
Swissmedic has announced an update to the therapeutic indications for Tepkinly®. This regulatory approval marks an extension of the product’s…
Europe
Swissmedic Approves Enhertu® for Extended Therapeutic Indications
Swissmedic has granted authorization for the extension of therapeutic indications for Enhertu® as of November 28, 2025. This update marks…
Europe
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 Ringerfundin B. Braun Infusion…
Europe
Swissmedic Spotlights Personnel Roles: Essential Update for Teams
On November 28, 2025, Swissmedic released details regarding changes in personnel requirements within its Abteilung Personal und Organisation department. This…
Europe
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 Business Partner (60–80%). This…
Europe
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. As of November 27,…
Europe
Swissmedic Opens Access to Swissdamed UDI Devices Playground
Swissmedic has announced the release of the Swissdamed UDI Devices Playground, an online tool designed to assist medical device stakeholders…
Europe
Urgent Swissmedic Recall: Specific Batch of Azelastin-Fluticason-Mepha Nasal Spray Withdrawn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 Spray, Suspension. This recall…
Latest News
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 risks tied to cybersecurity…
Latest News
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, identified as carrying a…
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