Medical device manufacturing hubs at the point-of-care 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 have resulted in significant changes to medical imaging, manufacturing 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.

The following survey should be completed by medical device manufacturing hubs either located at the point-of-care, or that have an agreement with a point-of-care facility for the manufacture and supply of medical devices. This includes:

• academic institutions linked to point-of-care facilities;
• start-ups and traditional manufacturers who are based within a point-of-care facility; and
• dedicated manufacturing hubs operated by a point-of-care facility.

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.

We request that one response is provided per clinic/facility/hub where possible.