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

Closes 1 Jan 2021

Opened 15 Oct 2020


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 we are consulting

Class I medical devices which are non-sterile and non-measuring, 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, 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).


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