Impact of amendments to the application process for inclusion of Class I medical devices in the Australian Register of Therapeutic Goods (ARTG)

Closed 31 May 2022

Opened 15 Oct 2020

Feedback updated 25 Sep 2023

We asked

Prior to December 2020, lower class medical devices such as Class I non-measuring, non-sterile devices and Class 1 in vitro diagnostic (IVD) devices were included in the Australian Register of Therapeutic Goods (ARTG) based on a computer-generated decision process with applicants self-declaring regulatory compliance. This resulted in some devices being incorrectly included in the ARTG at a lower classification with incorrect or incomplete application forms submitted by applicants. As a result, the TGA amended the Class I medical device inclusion process by revising and simplifying the Class I Declaration of Conformity (DoC) template form and introducing non-mandatory audits for some applications.

The TGA requested feedback on the new Class I device inclusion process through a survey published on TGA Consultation Hub.

You said

Fifty-two (52) responses were received from stakeholders, including sponsors, manufacturers, distributors, regulatory affairs consultants and industry peak bodies.

The majority of the respondents found the amended application process easy and well supported by guidance documentation, with minimal impact on business.  Some respondents reported initial difficulty for the manufacturer in completing the new DoC form, with suggestions for future improvements.  Of the respondents that had undergone an audit of their application, the vast majority found the process straightforward, and an outcome was received in less than five working days.

The feedback we received is summarised in more detail below:

  • The majority of respondents found the application process easy.
  • The majority of respondents had access to the manufacturer’s DoC prior to submitting their application.
  • Where respondents searched the TGA’s website for the DoC form, the majority easily located the form and found it simple to understand.
  • Responses were mixed on the difficulty for the manufacturer to fill out the new version of the DoC form. However, the majority of respondents did not face any issues in obtaining the DoC form from the manufacturer.
  • A minority of respondents that had submitted an application after 1 October 2020 reported being selected for a non-mandatory audit as part of the application review process. Of those respondents whose applications were selected for audit, the vast majority reported that they understood what information they were required to provide to the TGA.
  • Most respondents were satisfied with the time in which they received their application outcome, with 56% receiving the outcome in less than 5 working days, 21% within 10 working days, and 8% in more than 10 working days (not all respondents answered this question). 
  • Most respondents reported that these amendments had no impact on their business. A small minority of respondents reported a negative impact due to the mandatory requirement of a DoC while a small minority reported that the revised and simplified version of the DoC had a positive impact.
  • Most respondents preferred the option to provide a manufacturer’s DoC with the application for inclusion, rather than separately through the Manufacturer’s Evidence application.

We did

In response to the feedback received, the TGA made the new DoC form more user friendly by using plain language. The TGA will continue to work closely with stakeholders to implement changes to the regulatory process based on the feedback.

Published responses

View submitted responses where consent has been given to publish the response.


The Australian Government is undertaking a significant program to reform the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. The TGA has issued this survey as part of the Government’s reform program. 

The purpose of this survey is to seek your feedback on the amendments to the application process for inclusion of Class I medical devices in the Australian Register of Therapeutic Goods (ARTG)

Why your views matter

Class I export only medical devices are considered low risk devices. As such, they were included in the Australian Register of Therapeutic Goods (ARTG) through a computer-generated decision process with a self-declaration of compliances made by the sponsor. Through this mechanism, medical devices have been incorrectly included as Class I or applications have been found to be incomplete or inaccurate.

Hence, the TGA has undertaken amendments to the Class I medical devices inclusion process, such as a revised and simplified version of Class I Declaration of Conformity template, access to a Class I Declaration of Conformity ‘smart’ template changes to the application form, and altering the inclusion process to include non-mandatory audits for some applications.

We invite you to provide your feedback on the amendments by completing our online survey (click on the link below).

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in the survey or submission form).

Outcomes from the consultation will be provided to the Government for consideration.


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