Medical devices reforms: priority review pathway

Project overview

Priority review can provide faster access to medical devices.

In 2018, a priority review pathway was made available to expedite the assessment of certain medical devices.

Medical device applicants may seek a priority applicant determination to expedite a process of TGA conformity assessment or an application for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Applications subject to a priority applicant determination are allocated 'front-of-queue' priority throughout the assessment process. Determinations lapse after 6 months if the TGA does not receive any application to assess.

For more information about TGA conformity assessment and how to apply for ARTG inclusion, see Standards, guidelines & publications (medical devices & IVDs).

Guidance for industry

For guidance on seeking a priority applicant determination, including information on pre-submission meetings, eligibility criteria and supporting documentation required, see Priority applicant guidelines for medical devices (including IVDs).

To apply for a priority applicant determination for your medical device(s), please complete and submit the Application for priority applicant determination - medical devices form and pay the application fee.

For a list of priority applicant determinations approved by the TGA, see Medical devices (including IVDs) priority applicant determination notices.

Consultations

For more information see Consultations and reviews.