Australia Therapeutic Goods Act 1989 s41MI-41MK: Import, export, supply or manufacture a medical device in Australia only if it is included in the Register in relation to you or is covered by an emergency exemption, an exempt device, a section 41HB approval, a section 41HC authority or your section 41HD approval, and supply wholesale only such devices

What does s41MI-41MK require?

Importing, exporting, supplying or manufacturing in Australia a medical device that is not of a kind included in the Register in relation to that person, and not covered by an emergency exemption, the exempt device provisions, a special or experimental use approval, an authorised prescriber authority or a substitute approval granted to that person, is an offence: up to 5 years or 4,000 penalty units where harm results or is likely, 12 months or 1,000 penalty units otherwise, with a strict liability tier and civil penalties (section 41MIB). A defendant relying on an exemption must give notice of the evidence (section 41MIA), and such devices may be treated as prohibited imports or exports (section 41MJ). Supplying such a device to someone other than its ultimate consumer is a separate offence (120 penalty units, section 41MK).