AusBiotech is calling for member organisations working on active implantable medical devices (AIMD) and their accessories to comment on possible impacts of a recently released TGA proposal. The proposal includes changes relevant to some AIMD such as implantable cardiac pacemakers, implantable cardioverter-defibrillators, and cochlear implants, including associated accessories.
The proposal is intended to align Australian medical device regulation with EU medical device regulation amendments. Key elements include amending the classification of AIMD from Class AIMD to Class III, and reclassifying some non-invasive accessories as high-risk devices, for example, ear hooks.
AusBiotech is asking for comments on:
- the rationale provided that reclassifying non-invasive cochlear implant system accessories from Class I to Class III would protect patient safety
- increased and ongoing regulatory costs if enacted
- how companies might provide suitable conformity assessment evidence that would facilitate non-invasive accessories being included on the ARTG
- if there is value in requiring sponsors to re-apply for Class AIMD devices to be re-entered in the ARTG as Class III.
AusBiotech is preparing its response to this consultation and would like to hear from members affected by these proposed changes. Please contact Andrew Mosley, AusBiotech’s Policy and Programmes Manager, by 1 April 2019, to indicate if your company will be affected.