AusBiotech is seeking comment from affected members on two TGA consultations on medical devices: options for introducing a UDI system, and enhancing reporting of adverse effects.
As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry. It is developing responses to the two consultations below.
Consultation One - Exploring options for the introduction of an Australian Unique Device Identification (UDI) System
The TGA is running a series of consultations to inform the planning and design of the potential Australian implementation of a UDI system for medical technology. It is intended that this consultation will consider characteristics unique to the Australian environment, while acknowledging the benefits of a globally aligned UDI System, and will inform the policy decisions.
AusBiotech seeks Members views on:
- The benefits of an Australian UDI System across the broader health system;
- Whether the first phase of an Australian implementation should be limited to a small number of high-risk devices;
- What the impact will be should Australian implementation fully align with the International Medical Device Regulators Forum guidance;
- What mechanisms should be considered for submitting the UDI data to the TGA;
- The benefits for implementing the EU Basic UDI-Device Identifier in Australia; and
- The benefits of the Global Medical Device Nomenclature and how is it being used.
AusBiotech supported an earlier TGA consultation on whether to implement a UDI system in Australia, on the proviso Australia adopts a globally harmonised UDI system consistent with that of the US and EU. This includes ensuring alignment with international coding standards of UDI issuing agencies designated in the US and accredited in the US. Read AusBiotech’s full 2019 consultation response here.
Consultation 2 - Proposed enhancements to adverse event reporting for medical devices
The regulatory framework for medical devices in Australia strong and covers the technologies before and after they enter the market, with continuous monitoring and reporting once they enter the market. However, the TGA has identified that more can be done and proposes enhancements to adverse event reporting and to improve communication with medical device consumers.
AusBiotech seeks feedback on five proposals that aim to enhance the adverse event reporting system and improve access to safety information related to medical devices.
- Proposal 1 – make changes to the current adverse event reporting exemptions;
- Proposal 2 - strengthen reporting requirements for medical device adverse events;
- Proposal 3 - implement a programme of TGA inspections and audits of sponsor activities and premises to validate how they conduct their post-market surveillance obligations;
- Proposal 4 - review post-market definitions in the Medical Device Regulations; and,
- Proposal 5 – find ways to enhance communication between the TGA and the consumers of medical devices.
Read more on the consultation here.
For more information on either consultation, please email or call (03 9828 1455) Juliana Potulic, Policy and Programmes Manager, AusBiotech, with your views and comments by 4 November 2020.