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

  • Australia: Proposed changes to the Essential Principles for safety and performance

  • Australia: Proposed changes to the requirements for systems and procedure packs

  • Australia: Feedback sought on the regulation of certain self-testing IVDs in Australia

  • ...

March 28, 2019

Listing of LRP

Hong Kong's Medical Device Control Office (MDCO) has plans to issue new Guidance Notes on the Listing of Local Responsible Persons (LRPs). The application for listing of LRP applies to entities intending to submit applications for listing their first medi...

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...

September 18, 2018

MDCO has proposed a trial scheme for provisional approvals of Class II/III/IV Medical Devices. A list of criteria has to be fulfilled before approval. These criteria will help in shortening the approval time needed for medical device registration in Hong Kong: 

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