TGA has issued a new version of priority applicant guidelines for medical devices (including IVDs)
The purpose of these guidelines is to assist applicants seeking a conformity assessment (priority applicant) determination or medical devices (priority applicant) determination.
The changes in this new version are updated content, including a flow chart, to be more accurate, detailed, and consistent with current legislation and practices in consultation with the Regulatory Legal Services Branch.
For a medical device, including an in vitro diagnostic medical device (IVD), priority applicant determinations provide for a person to be a priority applicant in relation to either:
• an application for a conformity assessment certificate issued by the TGA or
• an application for inclusion in the Australian Register of Therapeutic Goods (ARTG).
When a priority applicant determination is made, the corresponding application for conformity assessment or ARTG inclusion will undergo priority consideration. This means that application will be allocated ‘front-of-queue’ priority throughout the relevant assessment processes by the TGA.
Obtaining a priority applicant determination does not, of itself, guarantee approval of the application for conformity assessment or inclusion. These applications must still be assessed against, and satisfy, the relevant legislative requirements, in order for conformity assessment certification to be issued, and/or for a kind of device to be included in the ARTG.
Priority applicant determinations cease to be in force after 6 months if no application for TGA conformity assessment or ARTG inclusion (as relevant) is made.
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