Medical devices reforms: priority review pathway

Project overview

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).

Priority applicants are given front-of-queue priority throughout the assessment process.

If no application is received by the TGA, the determination lapses after 6 months.

Consultations

More information

• Priority applicant guidelines for medical devices (including IVDs)
• Application for priority applicant determination - medical devices
• Medical devices (including IVDs) priority applicant determination notices
• Standards, guidelines and publications (medical devices & IVDs)