The Therapeutic Goods Administration (TGA), currently uses a standardised, risk-based international classification system (risk-based system) to assess and approve the use, consumption and implantation of medical devices in Australia. The same system is used in the United States, the European Union, the United Kingdom, Canada and Japan.
Despite this, Australia’s regulatory system to assess and approve the entry of medical devices into the market continues to come under scrutiny.
The TGA released its ‘Action Plan for Medical Devices’ on 4 April 2019. In that Plan, the TGA emphasises that the assessments it carries out go beyond the risk-based system for medium and high risk devices but also acknowledges that the TGA’s current framework could be more transparent and improved. In particular, the TGA considers that users of medical devices and healthcare professionals could be better informed when considering the use of particular medical devices.
In its Plan, the TGA has proposed a three-pronged approach:
- Improve how new devices get on the market:
- More stringent assessment process for new medical devices before they enter the market
- Establish expert groups for guidance on new technologies and the emerging impact of cybersecurity
- Strengthen the monitoring and follow-up of devices already in use:
- Introduce serial numbers for devices for tracking safety and quality assurance and, where applicable, for the purpose of servicing devices
- A streamlined reporting process for consumers, healthcare facilities and hospitals
- Provide more information to patients about the devices they use:
- Increase public awareness including by providing consumers with information and publishing decisions regarding TGA regulated devices
- Establish expert groups with consumer representation
The TGA aims to increase public confidence in Australia’s medical device regulation and is actively seeking feedback on how to best implement the Plan.
The TGA has already begun implementing the Plan and will recommend amendments to the Therapeutic Goods Act (1989) by late 2019. It is important to note that a review of the Australian regulatory guidelines for medical devices (ARGMD) is currently under way and some components have already been superseded by new guidance and regulatory amendments.
Significant reforms to the TGA are on the horizon. If you have any questions about how these changes to the TGA may impact you or your business, please contact a member of our Corporate and Commercial Team.