From early October 2020, the Therapeutic Goods Administration (TGA) will be implementing changes to the inclusion process for Class I non-sterile, non-measuring medical devices. These changes will include:

·    Enhancements to the application for inclusion in the Australian Register of Therapeutic Goods (ARTG) form; and

·    Modification of the process by which the TGA reviews applications for inclusion in the ARTG.

At this time, these changes will not apply to Class I IVD medical devices, Class I Export Only, and Class I IVD Export Only devices.

The changes are designed to make it easier for sponsors to provide the information the TGA needs to assess Class I applications. It will also make it easier for the TGA to assess applications and reduce the need to ask sponsors for more information to inform the decision to include a device in the ARTG.

This guidance outlines the key changes that will occur relating to including Class I non-sterile, non-measuring medical devices in the ARTG.

The TGA have developed a new tool for determining whether a product is a medical device. The tool is to help determine if a product requires entry onto the ARTG.

Summary of changes

Updates to the application form: The manufacturer’s Declaration of Conformity form must now be uploaded for all Class I non-sterile, non-measuring medical device applications. Sponsors have always been required to hold a copy of the Declaration of Conformity for Class I non-sterile, non-measuring medical devices included in the ARTG, but this will be required to be uploaded as part of the application.

Improved assessment process: When the modified process is implemented, applications for Class I and Class I system or procedure packs may be selected for a non-mandatory audit. The modified process is designed to determine if:

·               The product is a medical device;

·               The device is correctly classified;

·               The device has the appropriate conformity assessment procedures applied to it; and

·               The information supplied in or with the application is complete and correct.

Updates to processing times: For the majority of applications there will be no difference in the processing time of an application. However, some applications that may previously have been processed overnight may take up to four business days to be included in the ARTG.

All Class I devices included in the ARTG will continue to be subject to post-market reviews in accordance with the existing process.