Australia Therapeutic Goods Act 1989 s41ME-41MG: Manufacturers must not supply, and sponsors must not import, export or supply, a device to which the conformity assessment procedures have not been applied, unless the gap is covered by a conformity assessment standard or overseas regulator evidence is in force

What does s41ME-41MG require?

A manufacturer that supplies in Australia a device it makes without the conformity assessment procedures having been applied, and a sponsor that supplies (or imports or exports) such a device, commits an offence: up to 5 years or 4,000 penalty units where harm is likely because the procedures were not applied, 12 months or 1,000 penalty units otherwise, with strict liability tiers and civil penalties (section 41MEA). The offences do not apply to the extent the quality management system meets a conformity assessment standard covering the missing parts, or where an overseas regulator conformity assessment document is in force for the device; the defendant carries the evidential burden or, for civil proceedings, must prove the exception.