Approval for supervised and self-testing are two separate approval processes. Instructions will need to be simplified, a consumer help line should be available, and the step by step process for the users should be simple to follow. I assume this is what the TGA will be assessing in its review process for devices that have already proven efficacy (already approved for supervised use). A whole new device not currently listed will obviously need to provide all supporting data from tests and trials etc.
Approval for supervised and self-testing are two separate...
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