The outbreaks of COVID-19 infections has familiarised Australian consumers with the need for reliable screening and testing measures for the diagnosis of infections. Testing regimes have expanded from the use of PCR tests (seen as the gold standard) to the use of rapid antigen tests (RATs) that are able to be self-administered by users.

Regulatory requirements in brief – manufacturer’s evidence

RATs are medical devices which fall within the category of in vitro diagnostic (IVD) tests which are regulated by the Therapeutic Goods Administration under the Therapeutic Goods Act 1989 (Cth) and associated regulations. RATs cannot be lawfully supplied in Australia unless they are included on the Australian Register of Therapeutic Goods. The TGA has published guidance available here encouraging Australian sponsors to submit applications for the inclusion of COVID-19 tests, including RAT tests for self-administration, for inclusion in the Australian Register of Therapeutic Goods, noting that these applications will be prioritised for assessment.

Before submitting an application to the TGA, Australian sponsors who are proposing to supply the tests are required to submit certain manufacturer’s evidence about the design and manufacture of the devices to the TGA.

What does acceptable manufacturer's evidence include?

Acceptable manufacturer’s evidence includes:

• a TGA Conformity Assessment Certificate (which will most likely be required for tests manufactured in and for supply in Australia).
• As an alternative, overseas market authorisation evidence from a comparable overseas regulator (certain EU and Canadian market authorisations are acceptable).
• Declaration of Conformity to clause 7.5 of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations for a system or procedure pack.
• a Certificate issued under an MRA (Mutual Recognition Agreement) in accordance with Schedule 3 of the Regulations by a recognised Notified Body (relevant to medical devices only).

The Essential Principles[1] underpin the Conformity Assessment for medical devices. Essential Principle 15 is specific to the manufacture of IVDs and in relation to RATs for self-administration requires the manufacturer to demonstrate that:

• the IVD is designed and manufactured so that it performs appropriately for its intended purpose, taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in the user’s technique and environment.
• the information and instructions provided by the manufacturer must be easy for the user to understand and apply.
• it is designed and manufactured in a way that reduces, to the extent practicable, the risk of error in the use of the device, the handling of the sample and the interpretation of results.

Once the manufacturer’s evidence has been accepted by the TGA, the sponsor can submit an application for the device to be included on the Australian Register of Therapeutic Goods as a condition of its supply.

Conditions for supply

Approvals are subject to standard conditions that sponsors must comply with in supplying medical devices in the Australian market. Unsurprisingly, given the purpose of the RAT tests, their use by consumers and that they have been developed in relatively short time frames, the TGA may impose additional post-market conditions on sponsors relating to their supply, including that:

• sponsors provide additional support to users of the test such as a helpline or a website with additional information;
• all complaints and adverse events (including reporting false positive and false negative results) relating to the use of the product are submitted to the TGA as soon as they are received for a specified period;
• the submission of post-marketing reports at regular intervals including information on the distribution of the product, numbers of tests sold and adverse events or poor performance of the test;
• any other conditions that the TGA thinks necessary based on their assessment of the product, the information submitted and the information provided to consumers.

Sponsors are required to comply with these conditions, should anticipate them in making any application to the TGA and ensure that they have systems in place to monitor these issues and provide the information to the TGA following approval.

[1] Found in Part 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth)