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...

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)

    ...

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-...

November 1, 2017

  • US: Minimal Manipulation and Homologous Use Products

  • US: Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients

  • US: De Novo Classification Process (Evaluation of Automatic Class III Designation

  • US: Medical Device Develo...

August 24, 2017

  • Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP)

  • Australia: Guidelines on Code of Practice for Tamper-Evident Packaging of Therapeutic Goods

  • Brazil: Guidelines on Sets Up Requirements for the Implementation of the Brazil...

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