Federal Register of Legislation - Australian Government

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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Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
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Legislative Instrument
F2019L01660 : Authoritative PDF Document : 1.2MB Primary Document Icon F2019L01660 : ZIP Document : 0.1MB
54 pages

Explanatory Statement
F2019L01660ES : PDF Document : 0.9MB Primary Document Icon F2019L01660ES : ZIP Document : 0.1MB
64 pages

Replacement Explanatory Statement
F2019L01660RES01 : PDF Document : 3.5MB Primary Document Icon F2019L01660RES01 : ZIP Document : 2MB
165 pages
Registration Date:
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