November has seen a busy month in the Australian health sector, particularly with respect to consultations and reforms concerning medical devices. Key developments have been:

  • the TGA releasing two further consultations for their review of medicines and medical devices regulation; and
  • a Senate inquiry into the prostheses list being announced.

Internationally, the Software as a Medical Device (SaMD) Working Group of the International Medical Device Regulators Forum released a public consultation document concerning the clinical evaluation of SaMD.

Further details of these are below.

Review of medicines and medical devices

The TGA has released two further consultations for its review of medicines and medical devices regulation, which we reported here.

As part of the package of proposed reforms, the TGA will take steps to establish commercial bodies in Australia designated to undertake medical device assessments. Currently, only the TGA can perform conformity assessment in Australia, causing delay and timing uncertainty for applicants. The Designation of Australian conformity assessment bodies for medical devices consultation paper sets proposals for the implementation of a system to designate bodies to undertake conformity assessment certification of medical devices, including in vitro diagnostic medical devices for the Australian market.

The reform package also includes the creation of a priority review pathway for medical devices to expedite assessment of certain medical devices that are identified as “novel”. The Accelerated assessment of medical devices - Priority Review pathway consultation paper sets out the proposed criteria for what constitutes a “novel” medical device and an approach to implementation.

Submissions for both consultations close on 11 January 2017.

Prostheses List

Prostheses List (PL) reform has been a hotly contested issue by a range of deeply invested stakeholders and lobby groups for the last few years. The Government announced its policy in October with the release of the Industry Working Group on Private Health Insurance Prostheses Reform Final Report, accompanied by Minister Ley’s media release on the same day which gave more context to the recommendations in the report.

The key recommendation was that there be a reduction of benefits payable by private health insurers across the four high cost categories of the Prostheses List: cardiac, intra-ocular lens, hips and knees. The final report also recommended that the Prostheses List Advisory Committee’s (PLAC) functions be expanded to include a routine process of post-marketing monitoring and reviews and that the PLAC should consider developing a routine process for the assessment of devices for possible removal from the PL on clinical or cost-effectiveness grounds.

But just when we thought the Government was done with the reviews, on 21 November the Senate voted to support Senator Xenophon’s call for an inquiry into the PL to be undertaken by the Senate Community Affairs Committee.

The terms of reference of the review include:

  • the operation of relevant legislative and regulatory instruments;
  • opportunities for creating a more competitive basis for the purchase and reimbursement of prostheses;
  • the role and function of the PLAC and its subcommittees;
  • the cost of medical devices and prostheses for privately insured patients versus public hospital patients and patients in other countries; and
  • the impact the current PL framework has on the affordability of private health insurance in Australia.

Submissions should be received by 30 January 2017. The Committee has set a report date of 30 March 2017.

Software as a Medical Device

The development and take-up of software with “therapeutic” functionality has been steadily increasing for a number of years now. Currently, there is no special treatment of software within the therapeutic goods regulatory framework, so software is regulated under the Therapeutic Goods Act 1989 if it falls within the definition of “medical device” – hence the name “software as a medical device” or SaMD. This means that SaMD needs to go through the same regulatory approval process applicable to physical medical devices, and this framework may not be entirely suitable to deal with the highly technical and data-driven nature of SaMD, particularly when it comes to evaluating the clinical impacts and outcomes of SaMD. Accordingly, the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group is currently developing guidance for the clinical evaluation of SaMD.

The SaMD Working Group has released the Software as a Medical Device (SaMD): Clinical Evaluation consultation for public comment. The closing date for submissions has been extended to 13 December 2016.