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Source: Australian Department of Health

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Regulatory changes for custom-made medical devices

26 November 2020

Description

Under the new framework, regulatory requirements which apply from 25 February 2021, will:

  • introduce new definitions for personalised medical devices, thereby reducing the scope of the existing definition of a custom-made medical device;
  • change the conditions of exemption for custom-made medical devices to:
    • require annual reporting of custom-made devices supplied in the previous financial year;
    • allow the TGA to inspect production facilities;
    • require documentation about the device to be retained for 5 years (for non-implantable devices) or 15 years (for implantable devices); and
    • require manufacturers to provide information about each custom-made medical device to the intended recipient.
  • introduce the new concept of a Medical Device Production System (MDPS) and a framework for regulating these systems to allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification; and
  • update the classification rule for medical devices that record diagnostic images to include a broader range of technology now used for the purposes of recording patient anatomy for diagnosis and investigation, including anatomical models.
  • Background and overview
  • 1. New definitions for personalised medical devices
  • 2. Custom-made medical devices
  • 3. Patient-matched medical devices
  • 4. Medical Device Production Systems (MDPS)
  • 5. Adaptable medical devices
  • 6. Diagnostic images and anatomical models
  • Appendix 1: Personalised medical devices decision tree
  • Appendix 2: Statement template for custom-made medical devices

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