Medical device reforms: Regulatory changes

The Australian Government is undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia (the Reforms).

The Reforms aim to enhance the safety, performance and quality of medical devices in Australia and focus on patient safety.

The Reforms are in response to a number of inquiries and the identification that more can be done for patient safety:

• the independent Expert Review of Medicines and Medical Devices Regulation, 2015
• the Senate Community Affairs References Committee report on The number of women in Australia who have had transvaginal mesh implants and related matters, 2017
• An Action Plan for Medical Devices, 2019.

As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates medical devices, and is responsible for implementing the Reforms.

Regulatory changes

Regulatory changes to support the Reforms are ongoing:

Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022

• Mandatory reporting of adverse events by healthcare facilities

Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021

• Conformity assessment certification (Schedule 1)
• Application audit requirements (Schedule 1)

Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020

• Medical device definitions (Schedule 1)
• Conformity assessment certification (Schedule 1)
• System or procedure pack requirements (Schedule 1)

Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019

• Reclassification of devices (Schedule 1)
• Software regulation (Schedule 2)
• Personalised medical devices (Schedule 3)
• IVD companion diagnostics (Schedule 4)

Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018

• Disinfectants (Schedule 1 part 2)

Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018

• Tampons and menstrual cups (Schedule 1 part 6)

Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018

• Australian Conformity Assessment Bodies (Schedule 3)
• Preliminary assessment (Schedule 6)

Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017

• Conformity assessment bodies (Schedule 2)
• Priority Review (Schedule 6)

Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017

• Priority Review (Schedule 1)