TGA consultation on personalised medical devices manufacturing to ensure fit-for-purpose regulations

MedTech News: The Therapeutic Goods Administration (TGA) is gathering feedback on the regulatory needs of manufacturing sites for medical devices at the point of care. The consultation is part of TGA’s efforts to understand how the framework for custom-made and personalised medical devices applies to point-of-care device production.

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 or client.

In 2021, the government introduced a framework intended to apply an appropriate level of regulation to personalised, custom-made devices. The regulatory framework changed the definition of custom-made medical device and, in doing so, required the manufacturers of most products that were previously supplied under an exemption to add their devices to the Australian Register of Therapeutic Goods (ARTG). Products supplied in volumes of more than five a year need to be on the ARTG.

Now, the TGA is working to understand how the 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 initiative led TGA to post a survey aimed at manufacturing hubs operated by a point-of-care facility, manufacturers based in a point-of-care facility and academic sites.

One question asks respondents what would help them and their facility meet their regulatory obligations for medical devices. The agency also asked manufacturers where they expect to be able to find information about their regulatory obligations, such as from the administration who runs their facility and TGA, and posed multiple questions about the respondents’ organisations.
 
TGA released the consultation alongside three related surveys aimed at allied healthcare professionals, dental and oral health professionals and hospital and healthcare facilities. Each survey is intended to provide TGA with information about how to refine the custom-made medical device regulations to avoid unnecessary burdens. The surveys are tailored to the different sets of stakeholders involved in the point-of-care production of medical devices.

TGA is accepting responses to the survey of medical device manufacturing hubs at the point-of-care and survey of hospital and healthcare facility point-of-care manufacturing by 7 May. The regulator has clarified that the information provided will only be used to inform refinements to the regulatory framework and will not be used for compliance activities.

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