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

  • IMDRF: Guidance drafted on regulatory pathways for personalised medical devices

  • IMDRF: Comments solicited on terminologies for categorised adverse event reporting

  • ISO: Clinical performance studies for IVDs addressed in new ISO standard


June 28, 2019

  • EU/US: Cooperation on development of UDI database specifications

  • IMDRF: Assembly and technical guide for IMDRF ToC submissions

  • IMDRF: Clinical evaluation documents updated and circulated for comment

  • ISO: Updated standards on packaging for terminally...

June 28, 2019

On 25 March 2019, South Korea's Ministry of Food and Drug Safety (MFDS) published a notification titled "Professional revision of medical device manufacturing and quality control standards". This notification will take effect from 1 July 2019.

This revision is a re...

March 29, 2019

  • IMDRF: Optimising standards; Essential Principles; personalised medical devices

  • ISO: Third edition of ISO 14155 on clinical investigations reaches DIS stage

Click here for the full article on Global Regulatory Press.

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November 20, 2018

The US FDA announced a publication containing modifications made to the list of standards FDA recognizes for use in premarket review (FDA Recognized Consensus Standards). This publication will assist manufacturers who elect to declare conformity with consensus standard...

November 9, 2018

Korea MFDS' entry into the International Medical Device Regulators Forum (IMDRF), together with their intention to harmonize with the latest International Standard (ISO 13485:2016), will lay the foundations for Korea to prepare to join the Medical Device Single Audit P...

September 4, 2018

  • IMDRF: Consultations being held on guidance documents concerning adverse event reporting, labelling and UDI

  • ISO: Latest revisions of ISO 14971 and ISO/TR 24971 with national standards’ organisations for comment

  • ISO: Voting open on ISO/DIS 14155:2018(E)


May 24, 2018

“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions...

May 23, 2018

  • IMDRF: Final guidance documents published

  • IMDRF: Consultation held on ‘Essential Principles of Safety and Performance’ of medical devices and IVDs

  • IMDRF: Comments solicited on ‘Definitions for Personalized Medical Devices’

  • IMDRF: Draft version of ‘Op...

February 2, 2018

  • IMDRF: Essential Principles of safety and performance of medical devices and IVDs

Click here for the full article on Global Regulatory Press.

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