You may need to comply with these requirements if you are involved in the manufacture and preparation of therapeutic devices. You will only be required to comply if you are involved in the part of the process where a label is placed on the device.
There are certain exemptions. You will not need to comply with these requirements if the device:
- is a sterile therapeutic device (there are separate standards for sterile devices)
- is a non-sterile implantable device
- is manufactured and supplied for use to an individual
- is intended for dental use and is not implanted directly into bone or soft tissue
- is intended for veterinary use
- is for in vitro use
- is intended solely for export from Australia
- is for the purpose of conducting clinical trials.
