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Medical devices reforms: priority review pathway
Project status: implemented
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.
|Accelerated assessment of medical devices - Priority Review pathway - Implementation (historical document)||Consultation closed 11 January 2017|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.