The following updates have been made for Version 3.1:
- New chapters have been added on medical device software and personalised medical devices
- The joint prostheses chapter has been updated
- References to Real World Evidence, also known as 'other clinical experience data' have been updated throughout the guidelines
- Other sections have been updated to reflect recent TGA experience with clinical evidence for a range of medical devices
These guidelines provide details and guidance on the clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), under Australian legislation. For IVDs, there is also a supplementary document titled 'Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices', which should be reviewed in conjunction with these guidelines.
The guidelines are intended to be a common reference point for both industry and the regulator - assisting sponsors and manufacturers to collect, compile and present clinical evidence in a manner that meets regulatory requirements, while reflecting the TGA's approach to how it assesses clinical evidence.
- About these guidelines
- Part 1 - General requirements
- Legislative framework
- The essential principles
- Clinical evidence requirements
- Sources of clinical data
- Clinical evaluation
- The Clinical Evaluation Report (CER)
- Part 2 - Special topics
- Comparable devices including substantially equivalent devices
- Magnetic resonance imaging (MRI) considerations
- Personalised medical devices (PMDs)
- Part 3 - Requirements for specific device types
- In vitro diagnostic (IVD) medical devices
- Total and partial joint prostheses
- Cardiovascular devices to promote patency or functional flow
- Implantable pulse generator systems
- Heart valve replacements using a prosthetic valve
- Supportive Devices - Meshes, Patches and Tissue Adhesives
- Software as Medical Device
- Glossary and abbreviations
- Source material