The FDA has flagged a critical recall concerning Balt USA’s Mega Ballast Distal Access Platform devices,…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
Health Canada Aligns with IMDRF Standards for Medical Device Applications
In a significant step toward global regulatory alignment, Health Canada has announced it is adopting the…
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…
FDA Warns About Potential Reverse Flow Issue in Fresenius Kabi Large Volume Pump Sets
The FDA has issued an Early Alert regarding a potential high-risk issue with certain Fresenius Kabi…
Urgent Recall of SpeedControl Dials for SmartDrive MX2+ Power Assist Devices Due to Safety Hazards
Max Mobility/Permobil has initiated an urgent recall of SpeedControl Dials used in their SmartDrive MX2+ Power…