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What is determination?
Determination is a formal process the TGA to decide whether a Medical Device is eligible via the priority review pathway.
The sponsor of the Medical Device must submit an application for determination to allow the TGA to determine whether the medical device meets the eligibility criteria. These criteria ensure only products providing the most benefit to patients are eligible. Eligibility criteria for priority review determination is published on our website.
A priority applicant determination does not mean the medical device is registered
A priority applicant determination does not mean that the medical device has been approved and registered in the Australian Register of Therapeutic Goods (ARTG).
After obtaining a determination, the sponsor must lodge an application for registration. These applications are subject to a rigorous evaluation process resulting in a TGA decision on whether the medical device should be registered on the ARTG. Details of registered products approved for supply in Australia can be obtained by searching the ARTG.
Priority applicant determinations are in force for 6 months
Priority reviews remain in force for a period of 6 months from the initial effective date.
Details of Medical Devices that have an approved priority review designation, are listed below.
Approved determinations for Medical Devices (including IVDs)
| Device name | Manufacturer | Sponsor | Determination | Effective date | Lapse date | Intended purpose |
|---|---|---|---|---|---|---|
| LIFEPAK 35 monitor/defibrillator | Physio Control Inc. | Stryker Australia Pty Ltd | Conformity Assessment (Priority Applicant) | 30/05/2023 | 30/11/2023 | A monitor/defibrillator that is intended to provide monitoring functions; synchronized cardioversion; non-invasive pacing; and defibrillation therapy, with a rhythm recognition detection algorithm that can analyze the ECG while CPR is being performed. |
| Xpert HCV VL Fingerstick | Cepheid AB | Cepheid Holdings Pty Ltd | Conformity Assessment (Priority Applicant) | 24/06/2019 | 24/12/2019 | The HCV VL assay, performed on GeneXpert® Instrument Systems, is designed for the rapid quantitation of Hepatitis C Virus (HCV) RNA in human serum or plasma (EDTA) from DCV-infected individuals. |
| DAC (Defensive Antibacterial Coating) | Novagenit S.r.l. | Novagenit Australia Pty Ltd | Conformity Assessment (Priority Applicant) | 29/10/2019 | 29/04/2020 | The product is indicated in orthopaedy, traumatology and dentistry as a preventive measure against bacterial adhesion, colonization and biofilm formation. |
| CoreValve Evolut R System | Medtronic CoreValve LLC (United States of America) | Medtronic Australasia Pty Ltd | Conformity Assessment (Priority Applicant) | 9/12/2019 | 9/06/2020 | The Medtronic CoreValve™ Evolut R™ system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. |
| Edwards EVOQUE Tricuspid Valve Replacement System | Edwards Lifesciences LLC | Edwards Lifesciences | Medical devices (application for inclusion in the ARTG) | 13/11/2024 | 13/05/2025 | The EVOQUE tricuspid valve replacement system is indicated for the improvement of health status in patients with symptomatic severe regurgitation despite treated optimally with medical therapy for whom tricuspid valve replacement is deemed appropriate by a Heart Team. |
| CoreValve Evolut PRO System | Medtronic CoreValve LLC (United States of America) | Medtronic Australasia Pty Ltd | Conformity Assessment (Priority Applicant) | 9/12/2019 | 9/06/2020 | The Medtronic CoreValve™ Evolut PRO™ system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. |
| Edwards SAPIEN 3 Kit – Transfemoral | Edwards Lifesciences LLC (United States of America) | Edwards Lifesciences | Conformity Assessment (Priority Applicant) | 18/03/2020 | 18/09/2020 | The Edwards SAPIEN 3 Transcatheter Heart Valve System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for transcatheter heart valve replacement therapy. |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System | Edwards Lifesciences LLC (United States of America) | Edwards Lifesciences | Conformity Assessment (Priority Applicant) | 30/04/2020 | 30/10/2020 | The Edwards SAPIEN 3 ULTRA Transcatheter Heart Valve System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be to be appropriate for the transcatheter heart valve replacement therapy. |
| Medtronic CoreValve Evolut R System | Medtronic CoreValve LLC | Medtronic Australasia Pty Ltd | Conformity Assessment (Priority Applicant) | 28/04/2021 | 28/10/2021 | The Medtronic CoreValve Evolut R System is indicated for Proposed addition: The Medtronic CoreValve Evolut R system is also indicated for patients with a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as Society of Thoracic Surgeons operative risk score ≥8% or documented heart team agreement of risk for AVR due to frailty or comorbidities. |
| Medtronic CoreValve Evolut PRO System | Medtronic CoreValve LLC | Medtronic Australasia Pty Ltd | Conformity Assessment (Priority Applicant) | 28/04/2021 | 28/10/2021 | The Medtronic CoreValve Evolut PRO System is indicated for Proposed addition: The Medtronic CoreValve Evolut PRO system is also indicated for patients with a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as Society of Thoracic Surgeons operative risk score ≥8% or documented heart team agreement of risk for AVR due to frailty or comorbidities. |
| ReCerf Hip Resurfacing | MatOrtho Limited | MatOrtho Australia Pty Limited | Conformity Assessment (Priority Applicant) | 3/11/2023 | 3/05/2024 | The ReCerf Hip Resurfacing System is intended for use in hip resurfacing arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having osteoarthritis. ReCerf is used to treat patients who have been diagnosed with arthritis or to correct deformity or dysfunction of the hip. |