Regulatory Change in Australia – TGA’s wish list for 2019
TGA works hard to keep up to date in this rapidly changing world and that’s certainly the case this coming year. An indication of reforms to come can be gained from the extensive programme of recent consultations undertaken by the Agency. These include:
- Medical device cybersecurity, including a proposal to develop future guidance.
- Research programme and consultation on software regulation and cybersecurity conducted in co-operation with the Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO).
- Review of Therapeutic Goods Order 54 – Standards for Disinfectants TGA regulation of disinfectants has been complex and the overall framework has been revised in recent years to focus on higher risk instrument disinfectants. This review will update Therapeutic Goods Order 54 to meet current needs.
- Proposal for the regulation of IVD companion diagnostics. The TGA proposes introducing a new definition into regulation of companion diagnostics being an IVD essential to the safe use of a medicine or biological. The IVD classifications will also be amended to place companion diagnostics explicitly into IVD Class 3.
The TGA has also actively promulgated consultations from the IMDRF, four of which were conducted in 2018, on:
- a Unique Device Identification system (UDI);
- terminologies for categorised adverse event reporting;
- principles of labelling for medical devices and IVDs;
- definitions for personalised medical devices.
The UDI consultation is of particular note. The TGA halted activities on refinement of Global Medical Device Nomenclature System coding in anticipation of the UDI and made it clear that the Agency would await international progress. It appears that the Agency is returning to this issue.
Finally, the TGA indicates that it plans further work on recommendations of the Sansom review, including arrangements for designation of Australian third-party Conformity Assessment Bodies, further strengthening of post-market monitoring, and changes to the regulation of low-risk products including Class I medical devices.
The TGA is managing to implement a remarkably ambitious programme of reform while keeping the wheels turning on day-to-day regulatory activities. The limitations of Agency resources mean that it is imperative to continue to seek to leverage pre-existing reviews whenever possible, to apply robust risk management to review processes, and to continue to increase efforts in the post-market arena, where a small Agency can be very effective.
This is an extract from an article published in the February 2019 of Journal of Medical Device Regulation. Click here to subscribe and read more.
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