Is Medical Device a Software?

Attribute Name: isMedicalDeviceASoftware
Data Type: String
Max Length: 80
Repeatable: No
Code List:
AVP: Yes
Applies to: Base Unit
Last Modified: 05/02/2024

To identify if the medical device is a software as a medical device or incorporates software.

Useful Tips:
  • Only required for AusUDID

  • Leaving this attribute blank implies that this medical device is not software or does not incorporate software (when published to the AusUDID, this will be treated by the TGA as NOT_SOFTWARE)

  • For TGA 'Software as a medical device' maps to 'Software as a Medical Device', 'Incorporates software' maps to 'Medical Device incorporating software', If element is blank or 'Not Software then Map as 'No'