Federal Register of Legislation - Australian Government

Primary content

Regulations as made
These regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002, the Therapeutic Goods (Charges) Regulations 2018 and the Therapeutic Goods Regulations 1990 to reclassify a number of kinds of medical devices to align with the European Union, modernise the regulation of personalised medical devices and devices that are software (and related programmed or programmable devices) and introduce new, tailored regimes for faecal microbiota transplant products and in vitro diagnostic medical devices that are companion diagnostics.
Administered by: Health
Registered 18 Dec 2019
Tabling HistoryDate
Tabled HR04-Feb-2020
Tabled Senate04-Feb-2020
Date of repeal 26 Nov 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
TitleRegisterIdNumber
Authoritative version Therapeutic Goods (Charges) Regulations 2018
F2018L00774 
Authoritative version Therapeutic Goods (Medical Devices) Regulations 2002
F2002B00237SR 2002 No. 236
Authoritative version Therapeutic Goods Regulations 1990
F1996B00406SR 1990 No. 394