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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August 30, 2019

  • Albania: Amendments proposed to ‘Law on Medical Devices’

  • EU: New MDCG documents on Notified Bodies, the person responsible for regulatory compliance, and implant cards

  • EU: Supplementary guidance released on the Medical Device Vigilance System

  • EU: Gra...

November 5, 2018

  • EU: UDI guidance documents developed by the MDCG to support implementation of MDR

  • EU: Basic guidance issued for manufacturers on implementation of the MDR and IVDR

  • EU: Public rolling plan for implementation of new EU Regulations

  • EU: Proposed updates...

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