Industry News
The latest medical device regulatory news, clinical trials, and market insights
Urgent Recall of Paracetamol 500mg Tablets Due to Contamination Risk: Critical Information for Healthcare Stakeholders
Chelonia Healthcare Limited is issuing an urgent recall of specific batches of Paracetamol 500mg tablets due to potential contamination. This…
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 an infusion solution. This…
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 for medical devices across…
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 on enhancing post-market activities…
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 for the outer carton…
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 medicine Revozyn RTU 400…
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 issue, impact, and actions…
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 its 2021-2025 Strategic Plan.…
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 new discard functionality enables…
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 updated safety guidelines and…
Stay Updated on Key IMDRF Updates and Consultations
The International Medical Device Regulators Forum (IMDRF) has introduced a convenient way for clinical, quality, and regulatory professionals to stay…
Swissmedic Introduces Preliminary Decision Clarification Meetings for Human Medicinal Products
Swissmedic has announced an important update for stakeholders involved in authorisation procedures for human medicinal products. Starting soon, a new…