Reclassification of Active Medical Devices for Therapy with a Diagnostic Function. Version 1.0, April 2021: https://www.tga.gov.au/resource/reclassification-active-medical-devices-therapy-diagnostic-function
This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their obligations and outlines transitional arrangements to help comply with new regulations.
From 25 November 2021, active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.
The requirements for reclassification include:
- more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
- conformity assessment documents demonstrating procedures appropriate for a Class III device
- mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.
Reclassification of Medical Devices that Administer Medicines or Biologicals by Inhalation. Version 1.0, April 2021: https://www.tga.gov.au/resource/reclassification-medical-devices-administer-medicines-or-biologicals-inhalation
This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.
From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).
The requirements for reclassification include:
- more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to the device
- conformity assessment documents demonstrating procedures appropriate for their classification.
Reclassification of Active Implantable Medical Devices (AIMD). Version 1.0, April 2021: https://www.tga.gov.au/resource/reclassification-active-implantable-medical-devices-aimd
This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.
From 25 November 2021 active implantable medical devices will be required to be reclassified from Class AIMD to Class III.
The conformity assessment procedures applied to Class III medical devices are the same as for Class AIMD medical devices. Therefore, there will be no change to the level of the regulatory requirements or the level of scrutiny for these devices.