Australia Therapeutic Goods Act 1989 s41MA-41MD: Do not import, supply or export a medical device that fails the essential principles (other than labelling) without the Secretary's consent, apply for consent with the fee, and comply with every condition of a consent

What does s41MA-41MD require?

Bringing in, supplying or sending out a device that breaches the essential principles on any matter apart from labelling, where the Secretary has not consented and no emergency exemption applies, is an offence: up to 5 years' imprisonment or 4,000 penalty units where harm has resulted or is likely because of the non-compliance, 12 months or 1,000 penalty units for the fault offence, and a strict liability tier, with civil penalties in section 41MAA. The Secretary need not consider a consent application unless the prescribed fee is paid (section 41MAB). A consent may be unconditional or conditional and limited to particular devices; breaching a consent condition is an offence (2,000 penalty units where harm is likely, otherwise 500 or 100 penalty units strict liability) and a civil penalty (section 41MCA). Non-compliant devices may be treated as prohibited imports or exports under the Customs Act (section 41MD).