Following AMA calls for more detailed consultation on Prostheses List Part B reforms, the Department engaged PwC to conduct additional consultations with stakeholders.
Overall, the AMA supports the PwC recommendations and notes that the Department has already indicated its support for them subject to feedback received in response to this consultation.
In particular, the AMA supports the introduction of the proposed Tier 1 Abbreviated pathway for low-to-medium risk products already included on the ARTG and representing well-established biological technology substantially like other devices already on the PL, which will apply to most Part B listing applications.
This should be a more efficient process that will see effective products making their way into clinicians’ hands more quickly.
The AMA also argues that registered non-profit sponsors should be exempted from fees associated with listing on Part B of the Prostheses List.