We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
System and procedure packs must meet legal requirements for labelling and advertising.
Labels must clearly show the pack’s purpose, instructions, warnings, and include patient info if needed.
Advertising must be accurate, backed by evidence and must not be misleading. You are responsible for compliance across all platforms.
We monitor for compliance and can take enforcement action if these rules are broken. Following these rules is essential for legal supply and safe use in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.