Quality Management Systems
In Australia, the Therapeutic Goods Act of 1989 requires that manufacturers of therapeutic goods hold a licence. It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt from this requirement. Below you can find .pdf copies of our certification to manufacture said goods.
- ISO Certificate – Conformity Assessment Certificate – Medical Devices
- ISO 9001 Certificate – Quality Management Systems
For more information on these regulations, please visit the Australian Government Department of Health and Ageing website.