REGULATORY NEWS & UPDATES

The ARQon Gazette News

      Global Regulatory & Quality Bulletin 
The ARQon Gazette is a compilation of latest updates in the medical device and drug industry. These updates might have an impact to manufacturers and other industry participants.
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December 4, 2019

  • AHWP: Proposed competency framework for medical technology regulators

  • IMDRF: Principles and practice for medical device cybersecurity are drafted

  • IMDRF: Requirements for Regulatory Authority recognition of Conformity Assessment Bodies

  • IMDRF: China jo...

June 28, 2019

Executive Summary:

Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market developments and Asian Harmonization Working Party news. Part 2 was a guest presentation on the current Brexit and EU IVDR outlook. This...

November 5, 2018

  • AHWP: Guidance on labelling for in vitro diagnostic medical devices

  • Australia: Application fee change for export only medical devices

  • Australia: Updated requirements specified for preliminary assessment of applications for inclusion in the ARTG

  • Austr...

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