About reguide

What reguide does

reguide asks about your product in plain words and works out its likely classification under the Therapeutic Goods (Medical Devices) Regulations 2002, naming the clause that produced it. It then points to the funding routes worth looking at and to comparable products and past applications. The result is a draft pack that shows its reasons and sources.

What it is not

reguide gives information, not professional advice. It is not regulatory, legal, clinical or reimbursement advice, and it is not a decision by the TGA or by any funding body. The law and the TGA's guidance change, and a real product often has details a questionnaire cannot see.

Work with a specialist

Before you rely on any result, find a specialist in medical device regulation and reimbursement and take the draft pack to them. The pack is written for that conversation: every result names its clause and the answers it rests on, and every answer you gave as Not sure is listed for them.

Who is behind it

Reguide was built by Jorge Lozano-Lopez, who holds a PhD in engineering from RMIT University and has commercial experience in medical diagnostics. He built it so MedTech founders can see how the TGA is likely to classify their device, with every result traced to the text of the Therapeutic Goods (Medical Devices) Regulations 2002 rather than to an AI model's memory.

Questions, corrections or ideas are welcome: see the contact page.