It's not exactly clear from the question precisely what is planned, but here are a few pointers.
Custom devices currently are
exempt from entry onto the ARTG in Australia. So it's currently not actually possible to obtain a direct ARTG registration for a custom device, nor to apply for conformity assessment. There are some work-arounds which involve things like putting a custom device in a kit and registering the kit, but they are contrived and probably won't persist in the face of upcoming regulatory change.
There is a separate notification database where manufacturers of custom devices are required to notify TGA of their activities.
TGA is
actively looking at changing the regulations to require registration of some higher risk custom devices (e.g. implants). If this happens, registration and conformity assessment will be required.
Irrespective of registration, custom devices must still meet the essential principles and manufacturers are required to keep Technical Files showing safety and performance. There is some leeway for custom devices, in that TGA accepts they may be used in special circumstances and there may be some gaps in compliance which may be justified by risk.-benefit comparisons, but that does need to be justified in the Technical File.
Now, if a clinician is contemplating a clinical trial, that implies there is an evaluation required of clinical performance. This in turn means that there is unknown compliance for the outcomes being assessed in the trial. Therefore a clinical trial approval should be obtained via an ethics committee and TGA notified of the trial under the Clinical Trials Notification (CTN) scheme. It's important to understand that if the data from the trial are to be used in a future regulatory approval (anywhere in the world), then a regulator will only recognise those data if there is evidence that the trial was properly approved and managed.
Having said all of this, there is widespread lack of understanding of these requirements and it's not uncommon for custom devices to be manufactured and used with less than perfect documentation and evidence of compliance. So it's advisable to be cautious when looking at what others are doing as precedent.
Hope this all helps.
------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com------------------------------
Original Message:
Sent: 30-Aug-2019 08:56
From: Anonymous Member
Subject: Clinical Study Using a Custom Made Device (TGA)
This message was posted by a user wishing to remain anonymous
Hi Experts,
We are a small manufacturer based in Australia. A surgeon who is an inventor of a surgical instrument (class IIa) would like to use a custom made device manufactured for him for clinical publication.
Can someone please advise whether the custom made device can be used in clinical trials (surgeon to use custom device at his own practice) for publishing in scientific journals etc. Where do ethics committees come into play here or do they at all in this case? We know cosmetic and plastic surgeons publish new methods all the time under the declaration of Helsinki, without a separate committee (like NHMRC) assessment.
If the custom made device is cleared to be used by TGA on actual patients, why would a separate ethics committee process be needed to gather data in this case? The medical procedures are being done regardless during a surgeon's practice.
Aim is to generate clinical data for registering this device with the TGA (ARTG entry) under conformity assessment and prepare CER using both literature from the comparator device and subject device.
Any advise will be greatly appreciated.
Thank you in advance.