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…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Europe
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…
Europe
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.…
Europe
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…
Europe
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…
Europe
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…
Europe
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…
Europe
MHRA’s Latest Safety Guidance: Key Updates for Medical and Device Users – June 2025 Edition
The Medicines and Healthcare products Regulatory Agency (MHRA) has released the latest safety guidance for medication and medical device users…
Europe
Swissmedic Introduces Horizon Scanning Platform to Enhance Regulatory Oversight
Swissmedic has unveiled a new horizon scanning website to improve proactive regulatory measures. This initiative aims to streamline the identification…
Europe
IMDRF Working Group Updates Open for Feedback: Key Regulatory Insights
The International Medical Device Regulators Forum (IMDRF) has announced the availability of updates from its Working Groups, which are set…
Europe
Critical Updates on Field Safety Notices Issued Between 16 to 20 June 2025
The UK Government has released a detailed summary of Field Safety Notices (FSNs) issued from 16 to 20 June 2025.…
Europe
Building Global Capacity for Medical Device Safety: IMDRF Workshop Insights
The International Medical Device Regulators Forum (IMDRF) held a pivotal two-part workshop on 11 and 19 September 2024. This initiative…
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