25 February 2021
Please note: While submission of a notification to the TGA is required within two (2) months of initial manufacture/supply of a custom-made medical device, many stakeholders have not been meeting this obligation. If you were supplying a custom-made medical device prior to 25 February 2021, you should submit your notification as soon as you are able and before you register for transition. The TGA will not be pursuing compliance action against stakeholders who do not submit their notification before 25 February 2021.
Project overview
A new framework has been introduced to ensure an appropriate level of regulation is applied to Personalised Medical Devices to manage the risk these devices may pose.
Previously under the current medical devices regulatory framework, most Personalised Medical Devices (PMD) meet the definition of ‘custom-made’ and were exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).
Over the past two decades, rapid advances in computing technology and materials science have resulted in significant changes to medical imaging technology, manufacturing technology and, as a result, medical device technology. Newer methods of manufacture such as 3D-printing allow more complex and, in some cases, higher-risk medical devices to be personalised for an individual patient and supplied under the custom-made medical device exemption.
Following extensive consultation and liaison with other global regulators, the TGA has developed a new regulatory framework for PMD. This new framework has been introduced by the Government to ensure an appropriate level of regulation is applied to PMD in order to manage the risk they may pose. The new framework came into effect on 25 February 2021, and includes:
- new definitions for personalised medical devices, including patient-matched and adaptable medical devices, that reduce the scope of the custom-made medical device exemption
- changes to the conditions of exemption for custom-made medical devices
- new requirements for the inclusion of Medical Device Production System (MDPS) in the ARTG.
Medical Device Production Systems are a new concept in medical device regulation where an end-to-end system for the manufacture of medical devices can be included in the ARTG, thereby allowing medical devices to be manufactured within healthcare facilities without the need for the facility to include those devices in the ARTG. While the definition of an MDPS is included in the Regulations from 25 February 2021, this will not take effect until a subsequent legislative instrument declaring an MDPS to be a medical device is in place. This subsequent legislative instrument is likely to be drafted following work currently underway with the International Medical Device Regulators Forum (IMDRF) and the TGA has established regulatory structures to appropriately assess and evaluate these systems. This work is expected to take up to two years.
Guidance for industry
A guidance document for the new regulatory framework for PMD is available at: Personalised medical devices (including 3D-printed devices).
Answers to frequently asked questions about the framework is available at: Regulatory framework for personalised medical devices: Frequently asked questions.
More details here.
