Swissmedic has announced a temporary market authorization for Imjudo, a concentrate used in the preparation of…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
Stay Updated on Key IMDRF Updates and Consultations
The International Medical Device Regulators Forum (IMDRF) has introduced a convenient way for clinical, quality, and…