Swissmedic Updates: New Timelines & Label Requirements
On the 20th of November 2024 Swissmedic communicated a new press release regarding a few amendments to the Ordinance on…
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HPRA Announces Review of Proposed Fee Increases After Public Consultation
The Health Products Regulatory Authority (HPRA) Ireland has unveiled revisions to its proposed fee structure following a…
EU Updates MDCG 2023-3 Guidance on MDR & IVDR Vigilance
The European Commission has published an updated version of the MDCG 2023-3 Rev.1 Questions and Answers on…
MDCG 2022-5 Clarifies Sterilization Products for Medical Devices
The Medical Device Coordination Group (MDCG) has issued an important update to its guidance on the borderline…
AEMPS Launches New App for Hospital-Made Medical Devices
The Spanish Agency for Medicines and Medical Devices (AEMPS) has launched a new digital platform that enables…
The MDR Transition: Key Insights for MDR Certification Renewal
During RAPS Convergence 2024, one of the main topics on the agenda was the status of the transition from MDD…
New TGA Guide for Submitting a CMMD Notification
TGA has released a new update on how to submit a Custom-Made Medical Device (CMMD) notification. This…
Swissdamed to Align with EUDAMED XML Format
Swissmedic has announced that the Swissdamed registration system will use the same XML file format as EUDAMED for its…
Webinar: Regulatory Importer Responsibilities & Best Practices
This webinar has now expired: To Download The Full Presentation Click…
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