The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical devices regulation, issued guidelines describing how medical device manufacturers shall apply for inclusion of the COVID-19 test in the national register of medicinal products – the Australian Register of Therapeutic Goods (ARTG).
Australian Legislation on Medical Devices
The Therapeutic Goods Administration performs its functions related to medical devices in accordance with the following legislative acts:
- The Therapeutic Goods Act 1989,
- The Therapeutic Goods (Medical Devices) Regulations 2002, and
- The Therapeutic Goods Regulations 1990.
The TGA states that any and all medical devices falling within the scope of the aforementioned acts should be included in the national register of therapeutic goods in order to be allowed to be placed on the Australian medical devices` market.
Due to their nature and intended purpose, COVID-19 tests are in vitro diagnostic medical devices. It is important to mention that some of the IVD medical devices for self-testing are prohibited from marketing in Australia due to the high risks to patients` and public health the incorrect interpretation of the results could create.
Scope of the TGA Guidance
The guidance published by the TGA is intended to provide medical device manufacturers with the information regarding the regulatory procedures to be performed with regard to the test developed to be used in the context of the Coronavirus Disease 2019 (COVID-19). In particular, the document provides detailed guidelines and recommendations the manufacturers, suppliers or importers of COVID-19 tests shall follow in order to be allowed to supply their devices to the Australian customers (healthcare institutions and laboratories). The TGA also states that the aforementioned tests could be also supplied to the accredited pathology laboratories under the special regulatory framework – the emergency exemption.
It is also important to mention that all temporary and extraordinary measures described in the present TGA guidance will remain valid and should be applied only during the pandemic and public health emergency associated. The authority reserves the right to amend them if it would be reasonably necessary due to the situation.
Application for COVID-19 Test in Brief
The TGA states that due to the importance of addressing the outbreak of COVID-19, the appropriate tests are subject to priority review, even if it was not explicitly requested by the manufacturer, supplier, or importer applying for the registration. All applications related to medical devices that are vitally important in the context of coronavirus disease will be assessed by the authority within the shortest period of time, while the additional prioritization (if necessary) will be performed by the Chief Medical Officer.
In order to be allowed for marketing and use in Australia, any medical device should be duly included in the Australian Register of Therapeutic Goods – the national register of medical devices assessed and approved by the TGA. To initiate the procedure of inclusion, the applicant shall submit the appropriate application to the authority. Upon receipt and preliminary evaluation of the application, the TGA will inform the applicant about the additional documents to be provided to supplement the application.
In particular, the TGA expects the applicant to provided the information on clinical performance studies to demonstrate the sensitivity of the in vitro diagnostic (IVD) medical device in question in accordance with:
- The immunoglobulin type, and
- The days post-onset of symptoms.
Another important document to be provided together with the application is the instructions for use (IFU). According to the guidelines, the IFU should contain detailed and clear information regarding the way the results provided by the IVD device shall be interpreted by healthcare professionals using it. In particular, the IFU should contain special warnings regarding the use of the COVID-19 test subject to review in the acute phase of the illness and the way this could impact the accuracy and reliability of the results of the analysis.
Conditions for Approval
The TGA also describes specific conditions to be met in order to include the COVID19 test subject to review in the ARTG.
For instance, the applicant shall provide the authority with the additional evidence demonstrating compliance with the applicable safety and performance requirements within 12 months from the approval.
Other conditions should be applied in case of serology-based COVID-19 tests intended to be used at the point-of-care. The TGA states that such tests should be used only by healthcare professionals that have necessary qualification and skills to ensure the correct interpretation of the results, that is vitally important in the context of further treatment or other actions to be taken on the basis of such results, while incorrect interpretation will create additional risk to public health.
The TGA also emphasizes the importance of applying special precautions when collecting specimens for analysis. Healthcare professionals working with COVID-19 tests shall employ all appropriate measures necessary to reduce the risks associated with the transmission of the infection.
COVID-19 Tests Supply Limitations
According to the guidelines issued by the TGA, the IVD devices intended to be used as COVID-19 tests should not be freely marketed in Australia. The authority states that the manufacturer, supplier of important is allowed to supply COVID-19 tests only to:
- Accredited pathology laboratories,
- Registered medical practitioners,
- Healthcare professionals working in the appropriate healthcare institutions,
- Departments of health of all levels (Commonwealth, State, or Territory),
- Agencies acting on behalf of the appropriate department of health.
For the purpose of the requirements described hereabove, the pathology laboratory should be duly accredited by the National Association of Testing Authorities (NATA) and/or Royal College of Pathologists of Australia (RCPA) for Human Pathology Testing.
ARTG Inclusion Process in Detail
To assist the applicants with fulfilling their obligations in the course of registration and inclusion process, the TGA provides references to the appropriate guidelines and recommendations describing the procedures to be performed to include medical devices in the national register (ARTG). The whole process consists of the following consequent steps:
- Determination of whether the medical device in question is eligible to be included in the ARTG.
- Collecting the documents and supplementary materials (including the evidence supporting the claims made by the manufacturer). During this step, the applicant shall also determine the class of the medical device in accordance with the risk-based classification. In the case of the COVID-19 test, the applicant shall refer to the appropriate rules for in vitro diagnostic medical devices.
- Establishing access to the TGA Business Services system (TBS).
- Submission of the application in accordance with the class of the device under the risk-based classification.
- Processing the application by the regulating authority.
- Issuing the ARTG certificate of inclusion confirming that the particular medical device has been successfully included in the national register of medical devices.
- Additional responsibilities arising from further operations with the registered medical devices.
Summarizing the information provided hereabove, the present TGA guidelines describe the requirements to be met for including the COVID-19 tests to the national register of medical devices.
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