THERAPEUTIC GOODS ACT 1989 - SECT 41C What this Part is about

THERAPEUTIC GOODS ACT 1989 - SECT 41C

The essential principles set out the requirements relating to the safety and performance characteristics of medical devices. Compliance with applicable medical device standards is not required, but it is one way to establish compliance with essential principles. The regulations may make provision for and in relation to the Secretary causing a database of unique device identifiers of medical devices to be established and maintained.

Note:   Dealing in medical devices that do not comply with the essential principles may be an offence or may contravene a civil penalty provision: see Division   1 of Part   4 - 11.