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Medical devices reforms: priority review pathway

Project status: implemented

22 November 2021

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

Consultation Status
Accelerated assessment of medical devices - Priority Review pathway - Implementation (historical document) Consultation closed 11 January 2017
Revision of guidelines and application form Completed December 2020
Updating of website information and links Completed November 2021

For more information see Consultations and reviews.

Keep up to date

Please contact the TGA at devices@health.gov.au if you have any queries or comments.

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For more information about other reforms visit Medical devices reforms.