You will require this certificate if you intend to manufacture certain kinds of medical devices. Once a certificate has been issued, your device may be entered onto the Australian register of medical devices.
Devices that must be approved under this certificate include:
- devices that contain animal-originated tissue that has been made non-viable
- devices that contain tissues, cells, microbial or recombinant substances and are intended for use in or on a human body
- devices that incorporate (or are intended to incorporate) a substance that may be considered to assist the device
- Class 4 in-vitro devices.
