Hospital and healthcare facility point-of-care manufacturing survey

Overview

Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations).

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. Easier access to this technology and 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/client.

In 2021, following extensive consultation, the Australian Government introduced a new framework to ensure an appropriate level of regulation is applied to personalised devices. The new framework changes the legal rules for “custom-made” devices:

• Reducing the number and scope of devices that are considered “custom-made”
• Requiring most devices that are designed and manufactured for individuals to have TGA approval and inclusion in the ARTG before they can be imported, exported or supplied.

In parallel to the new framework being implemented, the TGA is focusing on how the new framework applies to manufacturing at the point-of-care and what refinements could be made to ensure regulation is appropriate without introducing unnecessary burden for point-of-care facilities.

TGA is focusing on how the new framework could be applied at the point-of-care.

The following survey should be completed by policy/governance teams who have oversight of hospitals and healthcare facilities involved in the modification, design, and/or manufacture of medical devices, including where those activities and devices take place, or are used, in clinical practice.

PLEASE NOTE - Your responses will be used for information-gathering to inform further refinements to our regulatory framework ONLY. Information collected in this survey will not be used for compliance activities.