Regulatory basics on medical devices for health practitioners v1.0

This guidance from the Therapeutic Goods Administration (TGA) is for Australian health practitioners who manufacture, supply and use medical devices. It helps them identify whether the devices are regulated by the TGA, and, if they are, it assists practitioners with how to comply with the requirements of the therapeutic goods legislation. Practitioners should note the information is indicative guidance only intended to help them identify:

a) how regulatory concepts might apply to them, and

b) the specific features of a medical device and how circumstances of their own practice/business may affect the way it is regulated in Australia.

Practitioners are responsible for ensuring they meet all relevant regulatory obligations when manufacturing, importing, supplying and using medical devices.

Main sections:

· Overview

· What is a medical device?

· Products that are not a medical device

· How are medical devices regulated?

· Manufacturing a medical device

· Manufacturer responsibilities

· Supplying a medical device

· Sector-specific examples for health practitioners