Department of Innovation, Industry, Science and Research
Strongly supports. While the approach will have positive impacts much will depend on the coverage of the proposed change and the effect of the proposed change, if the TGA will accept certificates for all classes of device.
Device Technologies Australia Pty Ltd
Supports and considers that this can be implemented irrespective of Proposal 2B.
Draeger Medical Australia Pty Ltd
Dynek Pty Ltd
Concerned that any concessions in Proposal 2A are nullified by Proposal 2B. Proposal 2B appears to withdraw the possibility of utilising CE certification to support their ARTG entry for Class IIb and Class III products.
EBR Regulatory Affairs Consultants
TGA should guarantee that this will not affect turnaround time for reviews. The confidence building period should be short. Are there costs associated with being on the MRA list? The recognition of third party assessments is taking too long. It is not clear if the TGA has a role in designating CABs via the MRA. Under what circumstances will the TGA refuse supply if the MRA is used?
Johnson & Johnson Pacific and Vision Care Australia
Magic Mobility (Red Milawa Pty Ltd)
MAQUET Australia Pty Ltd
Max Boccardo Associates
Support. Proposal 2A and 2C(ii) should be treated as one.
Medical Technology Association of Australia (MTAA)
Medtronic Australasia Pty Ltd
Support- but TGA needs to ensure that the timing of this coincides with the approval or designation of Conformity Assessment Bodies operating in Australia to prevent the situation of manufacturers choosing a Conformity Assessment Body that is later not approved.
Multigate Medical Products Pty Ltd
National Serological Reference Laboratory (NRL)
Accepting conformity assessment from third parties (particularly Europe) is inconsistent with Recommendation 8 (c) of the HTA review. Suggest that the quality of information provided by the European Notified Bodies be improved dramatically, standardised and monitored before they could be of use to Australia.
Support. Removes the disparity between Australian and overseas manufacturers.
Otto Bock Australia Pty Ltd
Paragon Therapeutic Technologies Pty Ltd (PTT)
Supports. Unclear who will be responsible for the appointment of third party CABs.
Pfizer Australia Pty Ltd
Queensland Health- Clinical and Statewide Services Division
Questions the requirements of the quality standards of third party assessors. Also unclear as to which authority will regulate these third parties or how third parties will guarantee quality of product.
Queensland Health– Chief Health Officer
Queensland Health– Centre for Healthcare Improvement
Support. The current approach is burdensome on Resmed and similar Australian manufacturers that distribute locally and overseas.