Australia TGA changes ARTG Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices

From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian Register of Therapeutic Goods (ARTG) has changed. These changes do not at this stage apply to Class 1 IVD medical devices, Class I Export Only and Class IIVD Export Only devices

Summary of changes

  • Applicants need to provide a manufacturer’s Declaration of Conformity with theirapplication to include the device in the ARTG , rather than simply holding this documentation such a document at the time they applyfor inclusion.
  • The manufacturer’s Declaration of Conformity form 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 inthe ARTG, the TGA will select the application for non-mandatory audit.
  • if the TGA is satisfied the product meets all the requirements for inclusion in the ARTG , the TGA will include thedevice in the ARTG within four (4) business days of receiving the application.
  • The TGA may conduct non-mandatory audits of Class I 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.

For more information, please refer to

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