Australia’s Therapeutic Goods Administration (TGA) is delaying implementation of regulatory changes proposed for the additive manufacturing, or 3D-printing, of devices, following requests from stakeholders to provide clarifications.
“The TGA plans to further explore other areas that were identified as requiring additional clarity prior to implementing regulatory change,” the regulatory authority said in a Thursday notice.
TGA received 24 comments on the regulatory changes proposed last November, most of which were from industry with a total of 15, including trade associations AdvaMed and the Medical Technology Association of Australia, as well as device firms Cook Medical, Johnson & Johnson and Stryker, followed by six comments from care providers, such as Royal Perth Hospital.
From additional clarity on the difference between how a custom-made vs. a patient-centric device is defined for regulatory purposes to the inclusion of anatomical models in the proposed framework, stakeholders urged TGA to address a wide range of existing barriers in the current 3D-printing landscape. “The need for clarification was especially evident regarding the boundary between the proposed ‘custom-made’ and the proposed ‘patient-specific’ definitions,” TGA said.
Most of the stakeholders’ comments opposed TGA’s proposed limitation on the annual number of custom-made devices that a manufacturer can supply, according to TGA.
Jamie Wolszon, AdvaMed associate vice president of technology and regulatory affairs, argued that “any number chosen as a limit is necessarily arbitrary, and may result in patients not being able to access needed technology.”
Cook Medical also disagreed with this proposed limitation, arguing that the “proviso that ‘there is no commercially available alternative medical device’ will effectively provide a limitation on supply of custom made devices,” Cook Medical wrote. “Furthermore, a very small arbitrary cap may limit access for patients who require custom made devices.”
However, this number is currently limited in the US to no more than five custom-made devices supplied per firm each year, according to Cook Medical.
The stakeholders’ submissions to TGA also pointed to other relatively new areas among regulatory authorities in the 3D-printing space, including the definition of a manufacturer and that of a production environment. These domains are evolving and expanding across hospitals and health systems.
“Only slightly more than half of the submissions commented explicitly” on the proposal for the definition of a device manufacturer, TGA said. “Nevertheless, those submissions were very conflicting.” About half agreed with the changes while the other half “raised issues like the need for further clarification, especially concerning the proposed medical device production system.”
Stakeholders made several other comparisons to regulations that other countries, such as the US and the EU, have implemented in recent years. These countries are among the 10 members of the International Medical Device Regulators Forum (IMDRF), seeking to address heterogeneous requirements to reduce regulatory burden by providing mechanisms for firms in the participating markets to concurrently comply with regulations in multiple jurisdictions.
Proposals that received positive feedback, in general, include those involving changes to the custom-made device conformity assessment procedure, permission for TGA to conduct inspections of custom-made device manufacturing sites, and regulating scaffolds containing materials of human origin under the device framework for alignment with other jurisdictions.
Further, most stakeholders responded in support of the proposed reclassification of software and anatomical models intended for recording diagnostic imaging.
In light of the issues and concerns the stakeholders raised, TGA said it “recognises the need for further stakeholder engagement on this subject.” The notice indicates the regulatory body intends to use lessons learned from its ongoing process as chair of the IMDRF working group charged with achieving harmonized definitions for personalized medical devices and vice versa in terms of using the global efforts to inform the regulatory changes specific to Australia.
The consultation on definitions for personalized medical devices
was opened in March at the 13th IMDRF meeting in Shanghai
, along with other consultations
on different topics.
Submissions received: Proposed regulatory changes related to personalised and 3D printed medical devices