Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG

The COVID-19 infection gets diagnosed using in vitro diagnostic medical devices (IVDs). We work with IVD suppliers to make sure tests are available.

This page is for sponsors (suppliers or importers) who want to include a COVID-19 test in the Australian Register of Therapeutic Goods (ARTG). 

We encourage sponsors to check out this page and the Legal Supply of COVID-19 test kits page. 

Apply

As a potential sponsor of a COVID-19 test, you will need to: 

1. Submit and have your Manufacturer's Evidence (conformity assessment certification) accepted by us.
2. Then submit your COVID-19 test application and pay the application fee.
3. We will contact you and tell you what information you need to supply.

Our website has pages to help you to know what to include and a step-by-step guide to the ARTG inclusion process:

• Medical device inclusion process 
• Overview of medical devices and IVD regulation.

Your application won't progress until you have paid all the relevant fees. 

A COVID-19 test can only be supplied once a sponsor has their ARTG inclusion entry number.

Sponsors of COVID-19 tests included in the ARTG have ongoing responsibilities under the: 

• Therapeutic Goods Act 1989, 
• Therapeutic Goods (Medical Device) Regulations 2002 and 
• Therapeutic Goods Advertising Code (the Advertising Code).

We encourage all sponsors of COVID-19 tests to review this information.

Additional conditions for tests

There are additional non-standard conditions for the supply of:

• COVID-19 point-of-care tests, and
• COVID-19 rapid antigen self-tests (for home use).

Post market review

To verify the performance of COVID-19 tests, we undertook a post-market review. This included:

• Post-market evaluation of serology-based point of care tests, 
• Post-market review of Nucleic Acid Tests, and 
• Post-market review of antigen and rapid antigen tests

The Peter Doherty Institute for Infection and Immunity assisted with the post-market verification process of some of these tests (serology point of care tests and rapid antigen tests). 

As part of the continued post-market monitoring and surveillance of these kits, we may request additional evidence from sponsors. This is usually to show the continued performance of the test kits against current and emerging COVID-19 variants.

See COVID-19 in vitro diagnostics

More information

COVID-19 test classification and GMDN collective term

Appropriate level 3 Global Medical Device Nomenclature (GMDN) collective term in the TGA database is "Severe acute respiratory syndrome-associated coronavirus IVDs" CT772.

If your device is for detection of multiple viruses, it is "Multiple-viruses IVDs" CT702.

• Classification rules for IVDs: Therapeutic Goods (Medical Devices) Regulations 2002 (Schedule 2A). 
• Multiple pathogens: Global Medical Device Nomenclature (GMDN) Terms. 

Conformity assessment (manufacturer's evidence)

For Class 3 IVDs, manufacturers must implement a full quality management system (QMS):

• Schedule 3, part 1, clause 1.1 of the Therapeutic Goods (Medical Devices) Regulations 2002. Full QMS assessment against ISO 13485:2016 includes assessment against clause 7.3 for design and development.
• Use of market authorisation evidence from comparable overseas regulators/assessment bodies for medical devices (including IVDs)

Fees for a Class 3 IVD

• Summary of fees and charges to applications submitted to the TGA
• Regulation 5.3(1)(j) of the Therapeutic Goods (Medical Devices) Regulations 2002 

COVID-19 updates

• COVID-19 page, find information about COVID-19 vaccines, tests, treatments and protective equipment.
• About Coronavirus (COVID-19), Department of Health and Aged Care website