In what was not a surprise based on the industry feedback, the Australian regulator of therapeutic goods (Therapeutic Goods Administration) will return to the drawing board with their proposed changes to the regulatory controls of 3D devices in hope to better define the scope of the changes.
Late 2017, the TGA released a consultation paper for comment from industry in a hope to develop better regulatory controls around the growing 3D printed custom medical devices provided in Australia. Some of the proposed changes were in alignment with other international regulators who have also identified what has become a growing industry. As the industry has grown in Australia, the regulations have not. Due to this, the Therapeutic Goods Administration proposed the following changes in the consultation:
- The inclusion of new definitions for personalised devices which may have resulted in a narrower scope for manufacturers to call their devices “Custom Made”.
- Changes to custom-made conformity assessment procedures, which could have included additional powers for the regulatory to inspect, an increase in the retention period of documentation to align with the EU and annual reporting requirements.
- Changes to the definition of a manufacturer which would result in a need for manufacturers to provide clearer instructions to users who are adopting a device for specific patients etc.
- A new classification for anatomical models and 3D print files, which would see these likely up classed to Class IIa and therefore require the manufacturer hold appropriate evidence of a conformity assessment.
- New arrangements for implantable devices with materials where the 3D device would be defined as a Class III medical device in place of a biological.
What was clear to the regulator on review of the feedback was that there is a clear lack of understanding of even the existing requirements for Custom Made devices in Australia, which as a result, impacted the proposed pathway the regulator intended to take. With this, the regulator will now revisit the proposed changes and will work with stakeholders to better define the pathway forward.
It should also be noted, that the impending changes do have an international flavour with the TGA leading the current working group on personalised medical devices within the International Medical Devices Regulators Forum (IMDRF).
What is clear across the industry is that a change is needed to strengthen the regulatory controls. However, gaining agreement between stakeholders on the direction needed will be a challenge. The proposed changes above will see a significant change to the regulatory requirements for these manufacturers and as a small industry, these requirements will most certainly place pressures unseen by some.
Next steps are likely to be a follow-up workshop and consultation to work through the feedback received in the first-round consultation. It’s clear from all of the exercises so far that:
- Everyone agrees there’s a need for tighter regulation of higher risk devices – specifically implants.
- There’s no such clarity on lower risk devices particularly things like dental devices and biomodels.
It appears the TGA is trying to find a path which strikes the right balance. Given their involvement in IMDRF project, the outcome of the Australian process is likely to set some precedents for where things go internationally – so it’s very important to watch what happens here.
Regardless of the changes that “will” eventuate in Australia, industry should be proactive now and gain a better understanding as to what’s required by way of technical documentation, clinical data etc and begin to implement if they haven’t already. This requirement has been in place for some time and manufacturers need to have this information available, as the regulator can request a review.
If you’re unsure what these changes mean to you or would like to understand the existing requirements to ensure you remain in compliance, be sure to contact us for a no-obligation discussion with one of your team members.
If you’re currently working through your CFDA applications for either IVD’s or Medical Devices, or are considering the China market for your product, please reach out to us for a free, no obligation discussion on how we may support you.