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...

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...

May 30, 2019

The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory harmonization. It consists of a group of medical device regulators from around the world* to accelerate international medical device r...

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.

Contact us at info@arqon.com.

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)

    ...

August 30, 2018

Singapore: HSA preparing manufacturer for the new ER IMDRF elements and cybersecurity.

The new version Essential Requirements (ER) checklist incorporate elements such as cybersecurity and detailed clarifications including risk management plan, clinical evaluation source...

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.

Contact us at info@arqon.com.

January 1, 2018

  • IMDRF: Personalised medicine; final guidance documents; draft proposals on use of patient registry data

  • ISO: New handbook on medical device Quality Management Systems

    Click here for the full article on Global Regulatory Press.

    Contact us at info@arq-...

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