How it works
From a plain description to a draft pack, in seven stages.
Preparation material, not regulatory advice. reguide helps you get ready for a conversation with a regulatory and reimbursement specialist. It does not replace one.
- 1
Your description
You describe the product. If you choose, OpenAI reads it once and fills in only the facts it states, each with the phrase it came from, and you check each one. Otherwise you answer every question yourself.
- 2
The questions
One question at a time, worded after the clause it decides. A product made of several parts is assessed part by part.
- 3
Is it a medical device?
Before any class: is each part a medical device under section 41BD of the Therapeutic Goods Act, is it excluded goods, or is it exempt decision support software?
- 4
The class
The rules of Schedule 2 (general devices) or Schedule 2A (IVDs) are applied in code. The product takes the highest class of its parts.
- 5
Who could pay
Your answers are read against dated copies of the Medicare Benefits Schedule and the Prescribed List: what may pay for the service, and what may pay for the device.
- 6
Similar devices
Past MSAC applications, and comparable entries on the Australian Register of Therapeutic Goods, found from the generic words you type for that search.
- 7
The draft pack
Everything above with its reasons and sources, as Word or PDF, ready for a specialist to check.
The class is worked out in code
A language model never decides a class. Each rule is written as code, one function per clause paragraph, holding the clause text it applies. When an answer the rule needs is missing, reguide says the result is pending rather than guess.
Where the rules come from
The Therapeutic Goods Act 1989, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Excluded Goods Determination, from the Federal Register of Legislation, with the TGA's guidance. Each pack lists the version it used, linked to the register.