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

  • ...

November 1, 2019

Beginning of August, SFDA announced that the new system will replace the current MDMA system and more technical files will be required from the manufacturers to provide evidence of compliance to a certain route. Click here for the new regulations (MDS-G5). The new syst...

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...

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...

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)

  • ...

August 30, 2018

Saudi Arabia: Saudi Food and Drug Authority (SFDA) has revised the product shelf life requirements to better facilitate the entry of medical devices into the country. Less time needed for clearance into the country will encourage the likelihood of increase in shipments...

July 4, 2018

The Saudi Food and Drug Authority (SFDA) informs medical devices manufacturers and their Authorized Representatives that Marketing Authorization fess (MDMA) has been updated according to the table below:

Notes:

  • New fees take into account number of products in the ap...

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