Prepare your TGA classification before you meet an adviser.
reguide works out the likely class of a medical device in Australia, names the clause that gives it, and drafts a pack you can take to a regulatory and reimbursement specialist.
Step 1
Describe it
Say what your product is, what it does, who uses it and on whom. Send the description nowhere, or let OpenAI read it once to skip questions it answers.
Step 2
Answer the questions
Each question follows the wording of the clause it decides. Not sure is always an answer: it is passed to your adviser, never guessed.
Step 3
Take the draft pack
The likely TGA class with the clause behind it, the funding routes to look at, comparable listings and past MSAC applications, as Word or PDF.
Who it is for
Founders and small teams with a medical device, software or IVD for the Australian market, who want to understand where they stand before paying for regulatory advice.
What it is not
Preparation material, not regulatory advice. Every result shows its clause and the answers it rests on, so a specialist can check it. More about reguide