Swissmedic has announced a temporary approval for the distribution of Glucose 5% B. Braun Infusionslösung in…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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.…
Supreme Deli LLC Recalls Boar’s Head Pecorino Romano Cheese Over Listeria Risks
Supreme Deli LLC, conducting business as Supreme Service Solutions, has announced a voluntary recall of specific…
FDA Grants Approval for Gene Therapy Addressing Spinal Muscular Atrophy Treatment Needs
The U.S. Food and Drug Administration (FDA) has officially approved Itvisma (onasemnogene abeparvovec-brve), a gene therapy…