Australia’s authority responsible for medical devices regulation, the Therapeutic Goods Administration (TGA), issued detailed guidelines on the regulatory approach to be applied to the test intended to identify the Coronavirus Disease 2019 (COVID-19).
COVID-19 Test Regulatory Background
The TGA implements all the measures necessary to ensure and expand the availability of test kits intended to be used in the context of the public health emergency associated with the outbreak of the COVID-19. As it is stated in the guidelines published by the TGA, the following approach could be applied when placing COVID-19 test on the market:
- General procedure that includes an assessment performed by the authority in an accelerated order (expedited assessment), followed by the inclusion in the national register of medical devices – the Australian Register of Therapeutic Goods (ARTG).
- Making test kits available directly to the accredited pathology laboratories under the appropriate emergency exemption.
It is also important to mention that the TGA explicitly prohibits marketing and advertising test kits intended for home use.
Special extraordinary measures introduced by the TGA are temporary and will remain effective only during the public health emergency associated thereto.
In order to be allowed to place its COVID-19 tests on the Australian market, the medical device manufacturer, or the sponsor interested in marketing the device should submit the appropriate application for the inclusion of the test kit in question in the ARTG. Later only the entity (sponsor or the manufacturer) directly indicated in the application and approval will be eligible to market the medical device.
The TGA additionally emphasizes that COVID-19 tests should be performed by healthcare professionals and thus should not be intended to be used by the patients themselves.
Expedited Assessment Framework
The TGA acknowledges that COVID-19 test kits are vitally important medical devices in the context of the outbreak of the disease. Thus, the authority intends to implement special measures aimed at ensuring and expanding the availability of the aforementioned devices to healthcare professionals. For this purpose, the TGA intends to apply an expedited assessment framework, a special process allowing the medical device manufacturers and importers to be able to place their test kits in the shortest period of time without any undue delays, while the authority will make its decision based on the information and performance data provided by the manufacturer (sponsor).
The authority also explicitly states that any and all applications related to the medical devices intended to be used to address the pandemic are deemed to be admissible and eligible for the accelerated review procedure.
Requirements for COVID-19 Test Kits
According to the guidelines published by the TGA, the medical device manufacturers or sponsors placing COVID-19 tests on the market shall comply with certain specific regulatory requirements. Such requirements include, inter alia, the following ones:
- Additional post-market reporting requirements intended to improve the exchange with the information associated with the disease and virus causing it,
- An obligation of the medical device manufacturer or the applicant to submit the additional information confirming that the device complies with all applicable safety and performance requirements. Such information should be provided to the authority within twelve months from the date the initial approval has been granted.
- Qualification requirements regarding the healthcare professional who will use test kits – this particular requirement covers serology-based tests (serological rapid screening tests).
The TGA states that correct interpretation of COVID-19 test results plays an important role in addressing the pandemic, while any inaccuracy or misrepresentation exposes patients and healthcare professionals to additional risks.
When applying for making the device available under the special regulatory framework, the medical device manufacturer or importer will be allowed to provide the device in question only to:
- Registered medical practitioners,
- Healthcare professionals working in the appropriate facilities,
- Duly accredited laboratories,
- Departments of the health of all the levels,
- Agencies of all the levels acting on behalf of the appropriate departments of health.
In order to make COVID-19 tests immediately available to the accredited pathology laboratories, the TGA allows the direct supply of the test kits to the laboratories.
To be eligible for this exemption, the laboratory should be accredited by the National Association of Testing Authorities (NATA). This special framework also has certain limitations, namely:
- The scope of the exemption covers only the direct supply of COVID-19 test kits to the accredited pathology laboratories. In order to be allowed to distribute test kits, a medical device manufacturer or importer shall submit an application for inclusion of the device in question to the national register (ARTG).
- In order to be eligible for the emergency exemption, medical device manufacturers and importers shall comply with the special requirements set forth in the appropriate regulation.
In-house IVDs for COVID-19 Diagnosing
Besides the test kits designed and produced by the medical device manufacturers, the laboratories could also develop COVID-19 tests themselves. For example, such in-house IVDs could be based on the Research Use Only Products (RUO). As it is explicitly stated in the TGA guidelines, in-house iv vitro diagnostic devices are not subject to mandatory inclusion to the national register of medical devices (ARTG).
The authority also provides a list of requirements a laboratory shall meet in order to be allowed to develop and use in-house in vitro diagnostic medical devices. In particular, the laboratory shall:
- Maintain compliance with the requirements set forth by the NPAAC standard “Requirements for the development and use of in-house in vitro diagnostic medical devices”,
- Be properly accredited by the National Association of Testing Authorities under the ISO 15189, and
- Duly notify the authority by July 1 of the appropriate financial year.
Self-collected COVID-19 Samples
In accordance with the TGA guidelines, self-collected samples should be previously validated either by the medical device manufacturer or by the laboratory (in case of in-house IVDs).
At the same time, the authority emphasizes that the laboratories are prohibited from advertising such IVD medical devices to the patients since such advertising would be considered as marketing of medical devices and thus require the inclusion of the devices in question to the national register.
Under the NPAAC standard “Requirements for the development and use of in-house in vitro diagnostic medical devices”, if due to certain reasons an in-house IVD in question cannot be properly validated, such device could be allowed for immediate use in case if it is vitally important in the context of the pandemic. At the same time, the laboratory shall also develop a plan describing further attempts to validate the in-house IVD and duly maintain the records to be provided to the authority upon request.
Summarizing the information provided hereabove, the new TGA guidelines describe the way the COVID-19 test kits should be made available to healthcare professionals and laboratories under the accelerated procedures in order to ensure and expand the availability of this vitally important in vitro diagnostic medical devices during the pandemic.
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