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

  • ...

June 28, 2019

  • Australia: Proposed reclassification of spinal implantable medical devices

  • Australia: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

  • Australia: Consultation held on regulation of software, including Software as a...

March 29, 2019

  • Australia: Reclassification of surgical mesh devices and publication of associated guidance

  • Australia: Proposed fees and charges for 2019–2020

  • Australia: Consultation held on changes to definitions and scope of device regulations

  • Australia: Potential...

September 4, 2018

  • Australia: 2018 fees and charges released by the Therapeutic Goods Administration

  • Australia: Application fee now charged for a Class I medical device ARTG entry

  • Australia: Therapeutic Goods Advertising Code 2018

  • Australia: Proposed regulatory changes...

May 23, 2018

  • Australia: Changes to the therapeutic goods advertising framework

  • Australia: Guidance on updating an existing Class 1–3 in-house IVD notification

  • Australia: Guidance for labelling medical devices to comply with the Poisons Standard

  • Bahrain: Draft GCC...

February 2, 2018

  • Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’

  • Australia: Implementation of new Uniform Recall Procedure for Therapeutic Goods

  • Australia: Guidance on priority review designations for medical devices, including IVDs

  • Austr...

January 1, 2018

  • Australia: Articles that alter the pH of body fluids are not medical devices

  • Australia: Up-classification of surgical mesh and provision of patient information

  • Australia: Guidance on pre-submission meetings with the TGA updated

  • China: New classificat...

August 24, 2017

  • Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016

  • Australia: Consultation held on future regulation of low risk products, including certain Class I medical devices

  • Australia: Guidance issued on clinical evidence for medical devices

  • ...

April 6, 2017

  • Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP

  • Australia: Regulatory reform consultations

  • Australia: MTAA appoints new CEO

  • China: Priority review and approval procedure effective 1 January 2017

  • China: Tighter rules...

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