KD&A’s Guide of Guides – Australia

KD&A's Guide of Guides - Australia

The world of medical device regulation is a complicated one. There is a lot of guidance documents available, but it’s very difficult to tell which will be useful and practical in the early stages of understanding the Australian regulatory framework. KD&A have put together a list of what we consider to be our vital five Therapeutic Goods Administration (TGA) guidance documents. Here they are:


  1. The Australian Regulatory Guidelines for Medical Devices (ARGMD). This is the go to document for all TGA medical device related information. Broken up into 3 sections, this one is a really useful and easy to read.
  2. The  Therapeutic Goods Advertising Code 2007. This Code describes the requirements for advertising here in Australia and applies to all therapeutic goods.
  3. IVD Guidance for Sponsors – A Roadmap to Market . This provides a great overview of what to expect and when for IVD sponsors. The IVD Regulation is new-ish so easy to understand guidance is always a welcome find!!
  4. Still on IVDs, the Application Audit (Technical File Review) of IVD Medical Device Applications document provides all the initial information you’ll need begin developing a compliant Technical File for IVD submissions.
  5. For unapproved therapeutic goods, including detail on clinical trials in Australia, check out the Access to Unapproved Therapeutic Goods – Clinical Trials in Australia

So there you have it. We hope this helps you find the information you we’re looking for.

For further detail on guidance documents or for expert regulatory advice regarding your medical device, contact KD&A.