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

  • ...

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...

August 30, 2019

  • China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing

  • EU/US : EMA/FDA Analysis Shows High Degree of Alignment in Marketing Application Decisions Between EU and US.

  • South Korea :  Five-year Master Plan for Clinical T...

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

  • China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export Licences Fees of Narcotic and Psychotropic Drugs

  • Philippines - FDA Circular No. 2012-007-A: Amending FDA Circular No. 2012-007: Re...

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 29, 2019

  • Australia - Procedure for Priority Review / Accelerated Approval

  • China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types of Drugs

  • South Korea - Procedure for Applying for a Manufacturing / Wholesale Licence

  • Taiwan - MOHW Announcement...

March 28, 2019

The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia.

Australia's Therapeutic Goods Administration (TGA) have published their plans in the event of either Brexit "no deal" or "deal"/exit extension...

November 5, 2018

  • AHWP: Guidance on labelling for in vitro diagnostic medical devices

  • Australia: Application fee change for export only medical devices

  • Australia: Updated requirements specified for preliminary assessment of applications for inclusion in the ARTG

  • Austr...

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...

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