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Standards, guidelines & publications (medical devices & IVDs)

Medical devices & IVDs

All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002.

Web page last updated: Thursday, 12 September 2013

URL: http://www.tga.gov.au/industry/devices-sgp.htm