Applicants can apply for priority applicant determination by submitting a form along with sufficient supporting information for medical devices. The relevant guideline is to assist applicants who are looking for either a conformity assessment (priority applicant) determination, or a medical devices (priority applicant) determination before relevant application.
Before the application of priority applicant determination, TGA grants the applicant to have a chance for requesting a pre-submission meeting with TGA, which is mainly to provide some flexibility on the guidance or comments on the strength of the proposed application, as well as suggestive requirements to the applicant for preparation. However, it is important to keep in mind that it does not guarantee that a determination of a priority application will eventually be approved.
To further explain, application for a “conformity assessment (priority applicant) determination” is suitable for those, who need a TGA-issued conformity assessment certificate and seek for the priority consideration. And for those who do not need a TGA-issued conformity assessment by leveraging the overseas conformity assessment, they are required to apply under a “medical devices (priority applicant) determination” in the inclusion process.
Getting a priority applicant determination does further also not automatically mean that the application is approved in ARTG. That is, due to the fact, that the compliance with Essential Principles is not yet assessed in the priority applicant determination. In addition, after having obtained the priority applicant determination, the determination will cease after 6 months if there is no application for TGA conformity assessment or ARTG inclusion.
According to the Therapeutic Goods (Medical Devices) Regulations 2002 (hereafter as “the Regulation”) to receive a priority applicant determination, each of the three requirements outlined in the Regulations must be met:
- 1. Life-threatening or seriously debilitating condition, defined by TGA as “the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition”; and
- 2. Unmet need / significant improvement, defined by TGA as the condition of either:
- - “No medical devices with that intended purpose are of a kind included in the ARTG”; or
- - “If one or more medical devices with that intended purpose are of a kind included in the ARTG, there is substantial evidence demonstrating that the safety or performance of the new device, when used for that intended purpose, provides a significant improvement compared to the existing devices”; and
- 3. Major clinical advantage, defined by TGA as the following three different conditions:
- - “The new device is a breakthrough technology” and “there is evidence that it offers a major clinical advantage over existing technology”; or
- - “There is evidence that the device offers a major clinical advantage over existing alternatives included in the ARTG”; or
- - “The new device is an IVD medical device and its early availability in Australia will result in a major public health benefit”.
Strong justifications to address the compliance of medical devices with the above-mentioned criteria along with the epidemiological and clinical evidence are crucial to the determination of the priority applicant. The epidemiological evidence for the first criterion of “life-threatening or seriously debilitating condition” could be, for example, the possibility and probability of life-threatening condition with the statistical figures of life expectancy and mortality in Australia.
Important to bear in mind is also that once the priority applicant determination is obtained, the “intended purpose” stated in the application must be the same as the proposed intended purpose for ARTG inclusion. The relevant TGA guideline can be supportive to instruct applicants with the direction for preparing the eligible evidence in relation to the three criteria, as well as for special conditions such as multiple devices and/or change applications.
Fig. 1 – Flowchart of the Application Process:
Priority applicant guidelines for medical devices (including IVDs)