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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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...

June 28, 2019

Executive Summary:

Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market developments and Asian Harmonization Working Party news. Part 2 was a guest presentation on the current Brexit and EU IVDR outlook. This...

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...

March 28, 2019

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of Standards & Technical Requirements by ASEAN Medical Device Committee (AMDC):​

March 28, 2019

Executive Summary:

The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam, Singapore and ASEAN Medical Device Directive ratification, as well as the recent update from China. This series is hosted by Medtech Insig...

December 11, 2018

The AMDTC is working on the following two key work items:

  • Classification of products as Medical Device or Non-Medical Device in the different ASEAN Member States (AMS);

  • Risk classification of identified medical devices with a view to align among the AMS.

The...

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...

August 30, 2018

ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Viet Nam and representatives from the ASEAN Secretariat. The Representatives from ASEAN Pharmaceutical Industry Club...

August 30, 2018

ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device regulation, which must be in place before the national elections; Vietnam's efforts to introduce practical, workable device regulatio...

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...

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