Australia Therapeutic Goods Act 1989
Chapter 4 Part 4-11: offences and civil penalty provisions relating to medical devices – Australia Therapeutic Goods Act 1989

Australia Therapeutic Goods Act 1989 s41ML-41MLB: Do not advertise an included device for a purpose not accepted for its ARTG inclusion, and never falsely represent that a device is on the Register, exempt, approved or authorised

What does s41ML-41MLB require?

Advertising, by any means, a device included in the Register as being for a purpose that was not accepted for that inclusion is an offence tiered from 5 years or 4,000 penalty units (where use for the advertised purpose has caused or is likely to cause harm) to 12 months or 1,000 penalty units and a 100 penalty unit strict liability offence, and a civil penalty of up to 5,000 penalty units for individuals and 50,000 for bodies corporate (section 41MLB). Making a false or misleading representation that devices are included in the Register, are exempt, or are the subject of a section 41HB approval, section 41HC authority or section 41HD approval attracts the same maximum civil penalties (section 41MLA), as does a false claim of an emergency exemption (section 41MND).

Maintained by Gerard Blokdyk

Other controls in Chapter 4 Part 4-11: offences and civil penalty provisions relating to medical devices – Australia Therapeutic Goods Act 1989

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