How the TGA regulates software based medical devices

Guidance

This guidance summarises the regulatory approach of the TGA for software based medical devices.

Last updated

24 February 2021

This guidance summarises the regulatory approach of the Therapeutic Goods Administration (TGA) for software based medical devices.

Contents

About this guidance
TGA regulation of software products
Key regulations
What to consider
Where to find more information
Definitions
Classification Rules
Essential Principles
Conformity Assessment Procedures

Supporting documents

How the TGA regulates software based medical devices [PDF, 763.63 KB]

How the TGA regulates software based medical devices [Word, 8.29 MB]

Topics