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]