If you intend to supply a medical device in Australia, you need approval from the Therapeutic Goods Administration (TGA) before it reaches the market. This approval comes through the ARTG inclusion process — the formal pathway for listing a device in the Australian Register of Therapeutic Goods (ARTG).
Knowing how the process works, what evidence to prepare, and when to submit it will help you meet your regulatory requirements without unnecessary delays. Read on to learn more.
Prepare Manufacturer’s Evidence
The process starts with gathering the manufacturer’s evidence. This may be a conformity assessment certificate or other documentation that proves your device meets the Essential Principles. Incomplete or outdated evidence can hold up your application, so accuracy and currency are essential.
Lodge the Application
Applications are made through the TGA’s online portal. Included in the ARTG inclusion process are providing detailed product information, uploading supporting documentation, and paying the required fee. The TGA then reviews your submission against the classification rules and regulatory requirements.
TGA Review and Inclusion
If your device meets the TGA requirements, it will be entered in the ARTG. Only then can you legally supply them in Australia.
Be Ready Before You Apply
A well-prepared submission moves through the ARTG inclusion process faster. Review your evidence, confirm your classification, ensure your documents are updated before applying, and collaborate with an experienced medical device sponsor. This preparation will save time and reduce the risk of setbacks.