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Medical devices/IVDs

26 November 2021
Declaration of Conformity procedures for Class I medical devices and Class 1 IVDs
4 December 2020
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Version Description of change Author Effective date
V1.0 Initial publication IVD Section 16/08/2010
V1
19 March 2021
The Therapeutic Goods (Excluded Purposes) Specification 2020 allows a limited number of self-tests to be made available in Australia
2 December 2020
Guidance for applicants (sponsors, manufacturers and agents) preparing for pre-submission meetings related to applications
2 December 2020
Guidelines is to assist applicants seeking a conformity assessment (priority applicant) determination or a medical devices (priority applicant) determination
15 September 2021
The Australian Government is undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia
30 June 2020
The report card shows the progress made by the TGA in the three strategies that make up the Action Plan for Medical Devices
4 April 2019
This Action Plan is a three part strategy to strengthen Australia’s regulatory system whilst continuing to be patient focused and have greater transparency
22 November 2021
Priority review can provide faster access to medical devices
30 June 2021
Project overview

Australian corporations can apply for an Australian conformity assessment body (Australian CAB) determination and issue conformity assessment certification for medical devices under Australian law.

Conformity assessment is the systematic and ongoing examination of...

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