You must 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 either:
- the device is a sterile therapeutic device (there are separate standards for sterile devices)
- the device is a non-sterile implantable device
- the device is manufactured and supplied for use to an individual
- the device is intended for dental use and is not implanted directly into bone or soft tissue
- the device is intended for veterinary use
- the device is for in vitro use
- the device is intended solely for export from Australia
- the device is for the purpose of conducting clinical trials.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.