Regulatory Guidelines for Medical Devices (2011), Section 19 Single-Use Devices (SUDs) and the Reuse of SUDs

“…When a SUD is reused, the TGA considers that the device has been remanufactured as the:
· intended purpose and design specifications for the device are altered from single use to reusable
· device may undergo manufacturing processes, such as sterilisation
· device may need to have components replaced so that it can be reused
· original manufacturer can no longer be considered responsible for the safety and performance of the device
The person responsible for undertaking these remanufacturing activities is considered to be a manufacturer under section 41BG(2) of the Therapeutic Goods Act 1989 and must comply with the therapeutic goods legislation relating to the manufacture of medical devices.”