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Custom Medical Device For Clinical Study

medwise

Involved In Discussions
#1
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 some 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.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
There are several routes to Clinical Investigations in Australia and not all of them involve going through the TGA. Also the level of involvement of ethics committees vary, depending on the specific situation. I can't answer responsibly based on the information you provided, and I also think that a public forum is not the best place for this kind of discussion. Please feel welcome to PM me if you'd like me to get more involved - If I had access to all (or most) of the relevant details I could point you in the right direction.
 
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