The TGA thanks respondents who provided submissions in response to the public consultation paper Proposed regulatory changes related to personalised and 3D printed medical devices.
A total of 24 submissions were received, which comprised:
- 15 submissions from industry and industry representatives
- 6 submissions from healthcare practitioners and organisations
- 2 submission from government organisations and universities
- 1 submission consumer representatives
All submissions from respondents that gave permission for publication on the TGA website are now available below in PDF format. Five respondents requested publication of only their name and work title, they are shown below without a link to their submission. Two industry respondents did not give permission for either their name or their submission to be published.
The paper proposed regulatory changes to address the increasing trend for personalised medical devices. While the regulatory changes were not limited to 3D printed medical devices, 3D printing was one of the main themes, as this technology enables personalisation of medical devices in a fast and potentially up-scalable manner. The responses to the five proposals show broad stakeholder support for the TGA's efforts and a strong awareness of the need for regulatory response and update.
Proposal 1: A tightening of the definition for custom-made device and the introduction of some new definitions
There were mixed responses regarding the newly proposed definitions. While most of the submissions recognised the need to add new definitions, a lot of the respondents did not believe the proposed definitions provided sufficient clarity. Several submissions suggested that examples might improve the proposal.
Most of the submissions were not in favour of a limitation in the number of custom-made devices to be produced by one manufacturer per year. Not many submissions commented on the proposed application and approval process for custom-made devices, but those that did, were not in favour of such a process.
Proposal 2: Changes to the custom-made device conformity assessment procedure
The responses on the proposed changes to the custom-made medical device conformity assessment procedure were positive throughout. The only point of critique was the potential for added cost and administrative burden posed by annual reporting of custom-made device activity and the requirement to store the device related data for a longer period. There were no objections to the proposal to allow the TGA to enter and inspect custom-made medical device manufacturing sites.
Proposal 3: Changes to the definition of manufacturer
Only slightly more than half of the submissions commented explicitly on proposal 3. Nevertheless, those submissions were very conflicting. About half of the submissions that took proposal 3 into consideration agreed with the TGA's proposal. The other half raised issues like the need for further clarification, especially concerning the proposed medical device production system. Also, the exemptions for health care practitioners and hospitals were not fully supported. Another issue raised was the potential for added cost and administrative burden. Stakeholders indicated their uncertainty about what exactly should be considered a medical device production system and appealed to the TGA to clarify and potentially give examples.
Proposal 4: New classification for anatomical models and digital 3D print files
The proposal to re-classify software and anatomical models used for recording diagnostic images was responded to in the majority of the submissions and was generally supported. Concerns were raised as to which anatomical models would be captured under the new provision, with some respondents requesting clarity on whether anatomical models used for education would be included. Some stakeholders also raised concerns about the potential additional cost and administrative burden a reclassification would entail. A few submissions debated whether the re-classification would be enforceable.
Proposal 5: Regulating scaffolds that contain human origin material under the devices framework rather than the biologicals framework
Responses provided on Proposal 5 were mostly positive, and welcomed the plan to align with other regulatory jurisdictions for these types of products. One submission requested clarification on devices that are made wholly from substantially altered human material, such as a fixation pin made from human bone, and there was a suggestion to differentiate between products with different cell types.
Consistent throughout the submissions was a recognition of the need for the TGA to take action to improve the current arrangements for custom-made medical device regulation, which are too broad. In general, the submissions indicated that there is still need for more clarity. It was evident in the submissions that the current regulatory requirements are in many cases not fully understood. Greater explanation is also needed regarding the TGA’s proposals for change. This is mirrored in the comments regarding the proposed definitions and the plural demand for explanatory examples. The need for clarification was especially evident regarding the boundary between the proposed ‘custom-made’ and the proposed ‘patient-specific’ definitions. There were also several submissions indicating uncertainty, and requesting further explanation of what exactly would be seen as a medical device production system.
What happens next?
The TGA has considered the submissions received and recognises the need for further stakeholder engagement on this subject. The TGA is currently leading an international harmonisation initiative for definitions for personalised medical devices through chairing an International Medical Device Regulators Forum (IMDRF) working group on this topic. There is a current public consultation (link is external) underway on these definitions and the TGA has used the results of its own consultation to inform its input to the IMDRF document. The TGA plans to further explore other areas that were identified as requiring additional clarity prior to implementing regulatory change.
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- Luke Rycken - Policy and Advocacy Officer, Australian Orthotic Prosthetic Association
- OMX Solutions