Chelonia Healthcare Limited is issuing an urgent recall of specific batches of Paracetamol 500mg tablets due…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Temporary Approval Granted for Imjudo Infusion Solution in German Packaging
Swissmedic has announced a temporary market authorization for Imjudo, a concentrate used in the preparation of…
Essential Field Safety Notices: Key Updates from 2–6 June 2025
In early June 2025, a series of Field Safety Notices were issued highlighting updates and recalls…
Spotlight on Post-Market Surveillance: Insights from the 23rd IMDRF Session Joint Workshop
Meta description: A new white paper highlights essential observations from the 23rd IMDRF Session Joint Workshop…
Critical Update: Incorrect Dose Instruction on Dulcolax 5mg Tablets Outer Carton
On October 2, 2025, Opella Healthcare UK LTD issued an urgent notification regarding a packaging error…
Urgent Veterinary Recall: Revozyn RTU 400 mg/ml for Cattle Affected
Swissmedic has issued an urgent announcement concerning the recall of a specific batch of the veterinary…
Essential Recall Alert: Inhixa 12,000IU Injection Packaging Error Announced
Meta description: Maxearn Limited recalls Inhixa 12,000IU injection due to carton labeling error. Learn about the…
IMDRF Publishes Strategic Plan Progress Report for 2021-2025
The International Medical Device Regulators Forum (IMDRF) has released a vital progress document detailing advancements under…
Swissdamed UDI Devices Module Adds Discard Functionality for Compliance Teams
On October 2, 2025, Swissmedic announced a key update to the Swissdamed UDI Devices module. The…
May 2025 MHRA Safety Updates: Key Guidance for Medicine and Medical Device Users
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its May 2025 Safety Roundup, providing…