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regulatory guidance

26 November 2021
Declaration of Conformity procedures for Class I medical devices and Class 1 IVDs
15 April 2021
Advertising for services that inherently involve therapeutic goods, need to comply with the legislative requirements
24 December 2021
Some additional requirements apply to advertising particular types of therapeutic goods
25 January 2022
Limitations apply to the use of certain representations in the advertising of therapeutic goods.
17 November 2021

These guidelines provide details and guidance on the clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), under Australian legislation. For IVDs, there is also a supplementary document titled 'Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices', which should be reviewed in conjunction with these guidelines.

21 August 2021
Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods
4 March 2021
User guide for sponsors of medical devices
7 January 2021

Due to COVID-19 pandemic and delays in EU MDR implementation

8 October 2020
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Version Description of change Author Effective date
V1.0 Original publication Therapeutic Goods Administration 20/04/2015

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