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

  • Australia: 2019 fees and charges released by the Therapeutic Goods Administration

  • Australia: Conformity assessment standards for medical device QMSs

  • Australia: TGA will no longer send out annual report reminders

  • Australia: Guidance issued on addressi...

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...

November 5, 2018

  • Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018

  • Brazil - Questions and Answers: Resolution RDC 242/2018 on Registration of Specific Medicinal Products

  • Canada - Form: Post-Notice of Compliance Changes: Level III

  • Chin...

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...

September 4, 2018

  • International - ICH Guidelines Implementation

  • Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018

  • China - CDE Notification on Issuance of the General Requirements for the Production Scales of Generic Drug Registration Batches (Trial)

  • ...

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...

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...

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