Australia, Therapeutic Goods Administration:

Australia, Therapeutic Goods Administration:

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.”

https://www.tga.gov.au/sites/default/files/devices-argmd-01.docx

By |2019-09-12T17:45:28+00:00May 1st, 2011|Global Regulatory Resource|0 Comments