These proposals form part of the Federal Government's reform program to strengthen the regulation of therapeutic goods in Australia and align with the European Union framework.

2019 looks set to be a year of change, with disruptive technology and a push towards greater international alignment continuing the focus on how medical devices are regulated in Australia. A number of proposals have been put forward to better harmonise Australian requirements with the international position (including with EU Medical Devices Regulation 2017/745) while ensuring Australia's regulation of therapeutic goods maintains the highest standards of quality, safety and efficacy.

Submissions are currently open on four consultation papers relating to Medical Devices, with proposed regulatory effect from 2020. Interested parties should review these proposals closely to consider how proposed changes may affect them and, where applicable, provide comments to the TGA ahead of the mid-February closing dates. All non-confidential responses to Consultation Papers are due for public release on the TGA website in the coming months.

In January 2019, the Therapeutic Goods Administration (TGA) released three consultation papers seeking public feedback on proposed regulatory reforms to medical devices which seek to better align Australia with international regulations on the topics of:

  • amended definitions and scope of the medical device regulatory framework in Australia;
  • reclassification of active medical devices for diagnosis and patient therapy from Class IIa/IIb to Class III; and
  • introducing a Unique Device Identification (UDI) system for medical devices in Australia.

These join the existing TGA consultation paper released in December 2018, continuing the TGA's engagement with software as a medical device, directed at regulatory guidance materials for the cyber-security of medical devices.

Stakeholder submissions for each of these proposals are sought by 18 February 2019 (or 14 February 2019 for cyber-security). These proposals form part of the Federal Government's reform program to strengthen the regulation of therapeutic goods in Australia and align with the European Union framework.

A brief outline of each proposal is included below to assist you in identifying areas that may impact your business. For further detail, also see the TGA Open Consultations & Reviews webpage:

Medical device cyber security - Draft Guidance Materials for Industry

Closing date: 14 February 2019

The TGA is seeking comments on the applicability and usefulness of content contained in the draft guideline to assist industry to comply with cyber-security responsibilities under the Therapeutic Goods Act (TG Act) and Regulations.

The Guidance document relates to a broad range of medical devices which have a software component and also include guidance for health care professionals, consumers and administrators who use or engage with systems that present a cyber-security risk.

Proposed timeframe: Final Regulatory Guidance document set for publication in mid-2019

Changes to definitions and the scope of the medical device regulatory framework in Australia

Closing date: 18 February 2019

This proposal is directed at harmonising Australia's regulation of medical devices with the EU Medical Devices Regulation 2017/745 (adopted by the EU in April 2017).

In addition to a number of definitional amendments proposed for the TG Act to better align the position with Europe, the proposal seeks to regulate certain products without an intended medical purpose (such as contact lenses) as medical devices.

Proposed timeframe for implementation: August 2020 (subject to passage of applicable legislative amendments)

Potential reclassification of active medical devices for diagnosis and patient therapy

Closing date: 18 February 2019

This proposal also represents an alignment with EU Regulation 2017/745, by introducing a new classification rule for active medical devices (including pacemakers, AEDs and other closed loop systems) with an integrated or incorporated diagnostic function that significantly determines patient management.

If implemented, these devices would be reclassified from Class IIa (low-medium) /Class IIb (medium-high risk), to Class III (high risk).

Proposed timeframe for implementation: August 2020 (subject to passage of applicable legislative amendments)

Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

Closing date: 18 February 2019

The TGA is proposing an Australian UDI System to assign listed medical devices (other than custom made medical devices) a unique alpha-numeric code, which is recorded in a centralised database.

The proposal seeks feedback on whether (and if so how) to establish such a system in Australia, including input on whether the TGA or another body should be responsible for administering and maintaining the centralised database.

Proposed timeframe for implementation: May 2021 to May 2025 (implementation of a UDI carrier on the device, label and packaging); May 2023 to May 2027 (direct marketing for reusable devices) (subject to passage of applicable legislative amendments)

Each of these proposals is designed to better harmonise and keep Australia's regulation of medical devices in line with international best practice. These proposals need to ensure that the uniquely Australian elements of the current system are reflected in moves to align with international approaches to avoid unexpected consequences including excessive costs of compliance for industry, healthcare professionals and consumers and the continuing strength of Australia's regulatory regime.