You are here
Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG
Sponsors' guide to COVID-19 tests, including advice for those new to therapeutic goods regulation.
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.
How to apply
As a potential sponsor of a COVID-19 test, you will need to:
- Submit and have your Manufacturer's Evidence (conformity assessment certification) accepted by us.
- Then submit your COVID-19 test application and pay the application fee.
- 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:
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 serology, rapid antigen point-of-care and self-tests, and
- combination (COVID/FLU) self-tests.
To verify the performance of COVID-19 tests, we undertook a post-market review. This included:
- serology-point of care tests,
- nucleic acid tests (NAT), and
- rapid antigen tests (POC and self-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.
Further information on the on-going requirements for sponsors and manufacturers can be found in our COVID-19 in vitro diagnostics guidance.
If you have any questions about the process, contact us:
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