Australia TGA Updates Comparable Devices in the Clinical Evidence Guidelines For Medical Devices

TGA has issued version 2.0 of Clinical evidence guidelines: Medical devices in March 2021 to update the section on Comparable …

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Australia TGA Releases New Standard for Medicines with Data Matrix Codes or Serialisation

A new standard clarifying requirements for serialisation and data matrix codes on medicines supplied in Australia commences on 1 January …

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Australia TGA Changes ARTG Inclusion Process for Class 1 IVD Medical Devices

On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the Australian …

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Australia’s Transition for Permitted Indications for Listed Medicines Ends 5 March 2021

On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under section 26A of the …

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Australia TGA Designs a New Regulatory Framework for Personalized Medical Devices (Including 3D-Printed Devices)

Under the current medical devices, regulatory framework custom-made medical devices are exempt from the requirement to be included in the …

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Australia TGA’s Staged Transition to eCTD-only for Prescription Medicines from 1 November 2020

This transition will see Australia adopt best practice standards that are currently applied across the world. Providing benefits for both …

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Australia TGA to Allow Registration of Over-The-Counter Low Dose Cannabidiol

Australia Therapeutic Goods Administration (TGA) announced on 15 December 2020 a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from …

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Australia TGA Issued a New Version of Priority Applicant Guidelines for Medical Devices (including IVDs)

TGA has issued a new version of priority applicant guidelines for medical devices (including IVDs) The purpose of these guidelines …

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Australia has Declared that Certain Sports Supplements are Therapeutic Goods

The TGA, has made a legislative instrument. The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020 (“the Amendment Order”) …

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