FDA High-Risk Medical Device Recall Pilot Expedites Alerts
The FDA medical device center is announcing a pilot program aimed at expediting public and healthcare provider…
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ISO 13485 Medical Devices: Global Regulatory Compliance
ISO 13485:2016 standards play a fundamental role in global regulatory compliance for medical devices. Nearly 30 years after the initial…
EUDAMED Roll-Out: New Q&A Document Under MDR and IVDR
A Q&A document was published outlining the practical aspects of the gradual roll-out of EUDAMED pursuant…
TGA IVD Sponsor Roadmap: Key Links & Steps for ARTG Inclusion
TGA (Australian Register of Therapeutic Goods) in Australia have updated a reference material called: “IVD sponsor:…
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…
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…
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