On 2 December 2020, the TGA priority applicant guidelines for Medical Devices and IVDs were published: “Priority applicant guidelines for Medical Devices (including IVDs)”.
The purpose of these guidelines is to provide MD Manufacturers and Sponsors with information on the criteria and on the process of definition of the priority applicant status for all MD types, including IVDs, in order to comply with the current regulations.
Process for defining the priority applicant
The regulatory framework provides for two types of priority applicant status: one for the conformity assessment certificate issued by TGA; the other for inclusion in the Australian Register of Therapeutic Goods (ARTG).
When a priority applicant status is carried out, the corresponding application for a conformity assessment certificate or for inclusion in the ARTG is checked as a matter of priority. This means that it is given the priority “front-of-queue”, during the relevant assessment processes carried out by TGA.
Attention! Even if you get a priority applicant status, it is still required to comply with all relevant legislative requirements (Therapeutic Goods Act 1989 particularly Chapter 4 of the Act and Therapeutic Goods (Medical Devices) Regulations 2002).
Another important aspect is the timing of applications. In fact, it is necessary to present them within 6 months from the date on which the priority applicant status was granted, otherwise this condition is no longer valid.
For more information on submitting applications, please consult the guide “Pre-submission meetings with TGA”.
Three TGA criteria for the definition of the priority applicant
In the guideline TGA stresses that in order to benefit from the definition of the priority applicant status, the Medical Device must meet three criteria, which we report below:
- “Life-threatening or seriously debilitating condition”. This criterion requires that the intended purpose of the MD is monitoring, treatment, prevention or diagnosis of a life-threatening and/or severely debilitating condition;
- “Unmet need / significant improvement”. This criterion can be met in two ways. In the first case in the ARTG there is no MD which is intended for the same purpose, while in the second case the new MD shows a significant improvement compared to the existing MDs already included in the ARTG.
- “Major clinical advantage (or in the case of IVDs, major public health benefit)”. For all MDs, including IVDs, this criterion may be met if at least one of the following case applies to the device: the new MD has an innovative technology and there is evidence that demonstrates a greater clinical advantage over existing technology or the MD offers an important clinical advantage over devices already included in the ARTG. In addition, if the device is an IVD and it is available in advance in Australia, the criterion can be met, as it can be an important benefit to public health.
Do you need more information?
Contact us if you need more details or if you wish to request strategic-regulatory consultancy in this matter.