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Medical Devices-Asia and ROW Regulatory News-Sep. 2023

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  • Information entered on the ARTG is not complete or correct
  • Manufacturer’s details (e.g. name or address) have changed
  • Change of GMDN code by the manufacturer to a more relevant, active, or preferred code
  • Change to the intended purpose of the device by the manufacturer (e.g. broadening or reducing clinical indications)
  • Manufacturer has added or removed product variants
  • Total number of devices has changed (increased or decreased)
  • Manufacturer changed the Unique Product Identifier (UPI)
  • Sponsor wants to vary the list of IVD devices included in the ARTG entry
  • 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.
  • 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 their classification
  • A mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.