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Clinical evidence guidelines

Guidance

Guidelines on the clinical evidence requirements for medical devices, including In Vitro Diagnostic medical devices (IVDs), under Australian legislation. 

Last updated

Medical device clinical evidence requirements, including IVDs, are outlined in these guidelines.

Both industry and regulators can use the guidelines as a reference. Sponsors and manufacturers can use them to collect, compile, and present clinical evidence.

Changes made from the previous version

  • New chapters on Ophthalmic devices and medical devices incorporating a medicine.
  • Changes to Surgical mesh and Breast implants and tissue expander.
  • Added references to Real World Data and Real-World Evidence.
  • Changes to reflect recent TGA experience with clinical evidence for a range of medical devices.

Contents

  • About these guidelines
  • Part 1 - General requirements
    1. Legislative framework
    2. The essential principles
    3. Clinical evidence requirements
    4. Sources of clinical data
    5. Clinical evaluation
    6. The Clinical Evaluation Report (CER)
  • Part 2 - Special topics
    1. Comparable devices including substantially equivalent devices
    2. Magnetic resonance imaging (MRI) considerations
    3. Personalised medical devices (PMDs)
  • Part 3 - Requirements for specific device types
    1. In vitro diagnostic (IVD) medical devices
    2. Total and partial joint prostheses
    3. Cardiovascular devices to promote patency or functional flow
    4. Implantable pulse generator systems
    5. Heart valve replacements using a prosthetic valve
    6. Supportive Devices - Meshes, Patches and Tissue Adhesives
    7. Software as Medical Device
  • Glossary and abbreviations
  • Source material

Download the guidance

 

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