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Medical devices/IVDs

Guidance for Declaration of Conformity

26 November 2021
Declaration of Conformity procedures for Class I medical devices and Class 1 IVDs

Version history

4 December 2020
...
Version Description of change Author Effective date
V1.0 Initial publication IVD Section 16/08/2010
V1

Medical devices reforms: Review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia

19 March 2021
The Therapeutic Goods (Excluded Purposes) Specification 2020 allows a limited number of self-tests to be made available in Australia

Pre-submission meetings with TGA

2 December 2020
Guidance for applicants (sponsors, manufacturers and agents) preparing for pre-submission meetings related to applications

Priority applicant guidelines for medical devices (including IVDs)

2 December 2020
Guidelines is to assist applicants seeking a conformity assessment (priority applicant) determination or a medical devices (priority applicant) determination

Medical device reforms: Regulatory changes

15 September 2021
The Australian Government is undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia

Action Plan for Medical Devices - Progress Report Card: April 2020

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

An 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

Medical devices reforms: priority review pathway

22 November 2021
Priority review can provide faster access to medical devices

Medical devices reforms: Conformity assessment bodies

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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