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

Overview

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.