Changes to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG

On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed. This follows similar changes made on 1 October 2020, for Class I non-measuring, non-sterile medical devices. These changes do not at this stage apply to, Class I Export Only and Class I IVD Export Only medical devices.

This guidance outlines the key changes, and provides links to other TGA website pages to provide further information about including Class I medical devices and Class 1 IVD medical devices in the ARTG.

Summary of changes

• Applicants need to provide a manufacturer's Declaration of Conformity with their application to include the device in the ARTG, rather than simply holding this documentation such a document at the time they apply for inclusion.
• The manufacturer's Declaration of Conformity template for Class I non-sterile, non-measuring devices has been revised to be more user-friendly.
• The TGA will assess applications for compliance with the legal requirements for Class I medical devices to be included in the ARTG.
• After conducting the assessment:
  • if the TGA is not satisfied the product meets all the requirements for inclusion in the ARTG, the TGA will select the application for non-mandatory audit; or
  • if the TGA is satisfied the product meets all the requirements for inclusion in the ARTG , the TGA will include the device in the ARTG within four (4) business days of receiving the application.
• The TGA may conduct non-mandatory audits of Class I medical device or Class 1 IVD applications where, for example, there are concerns regarding a kind of device or it appears from the application that:
  • The device is not a medical device;
  • The device is incorrectly classified;
  • The device does not comply with the essential principles;
  • The device has not had the appropriate conformity assessment procedures applied to it; or
  • The information supplied in or with the application is not complete or correct.
• You can check if your product is a medical device using the SME Assist tool.
• All Class I medical devices and Class 1 IVD medical devices included in the ARTG will continue to be subject to post-market reviews, in accordance with the existing process.

Invitation to provide feedback

We invite sponsors of Class I medical devices and Class 1 IVD medical devices to provide their feedback on the changes made to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG by answering an online survey.