Swissmedic announces a temporary distribution authorization for Ringerlactat B. Braun Infusion Solution packaged in German labeling.…
Category: Europe
europe updates on medical device regulation and quality.
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Urgent Swissmedic Recall: Specific Batch of Azelastin-Fluticason-Mepha Nasal Spray Withdrawn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…
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…
Swissmedic Authorizes Temporary Distribution of Glucose 5% Infusion Solution in German Packaging
Swissmedic has announced a temporary approval for the distribution of Glucose 5% B. Braun Infusionslösung in…
Swissmedic Approves Temporary Distribution of NaCl 0.9% Infusion in Foreign Packaging
On November 26, 2025, Swissmedic announced the temporary approval for distribution of NaCl 0.9% infusion solution…
Critical Updates: Field Safety Notices Issued for Medical Devices (Nov 17–21, 2025)
New updates on medical device safety concern all clinical, quality, and regulatory professionals. Between November 17…
Important Safety Notice: Updated Safety Information Missing from Moclobemide 150mg Tablets Packaging
On November 25, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 4…
Swissmedic Announces Financial Consolidation Plan Amid Regulatory Priorities
Swissmedic, Switzerland’s key regulatory authority for therapeutic products, has outlined measures to strengthen its financial position.…