Questions people ask

No. reguide prepares material for a conversation with a regulatory and reimbursement specialist. Take the draft pack to one before you rely on any result. See About.

The rules are checked against the TGA's own published examples, where the TGA states both the class and the rule. A result is only as good as the answers behind it, which is why every result shows the answers it rests on, and why Not sure is passed to your adviser rather than guessed.

Medical devices, including software and in vitro diagnostic devices (IVDs), for the Australian market only: Schedule 2 and Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002.

Your description, answers and pack are saved only in the folder you choose. Our server reads your answers to work out the class, and keeps nothing. Your description is sent to OpenAI only if you choose it on the first screen. See Privacy.

The results are the same. Not sending it means a slightly longer interview, about seven more questions for a typical device, because you answer every question yourself. With OpenAI, the facts your description states are filled in for you, each with the phrase it came from.

Yes. Open the assessment and choose Change answers; the pack is worked out again from your answers.