Federal Register of Legislation - Australian Government

Primary content

SLI 2010 No. 25 Regulations as made
These Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 and create a specialised regulatory framework for in-vitro diagnostic medical devices.
Administered by: Health
Registered 03 Mar 2010
Tabling HistoryDate
Tabled HR09-Mar-2010
Tabled Senate09-Mar-2010
Date of repeal 30 Jun 2014
Repealed by Therapeutic Goods Legislation Amendment (In Vitro Diagnostic Medical Devices) Regulation 2014
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Legislative Instrument
F2010L00469 : Authoritative PDF Document : 0.3MB Primary Document Icon F2010L00469 : ZIP Document : 69KB
50 pages

Explanatory Statement
F2010L00469ES : PDF Document : 99KB Primary Document Icon F2010L00469ES : ZIP Document : 42KB
29 pages

Supporting Material
F2010L00469SMN01 : PDF Document : 86KB Primary Document Icon F2010L00469SMN01 : ZIP Document : 36KB
21 pages

Incorporated Documents
Collective terms available as device nomenclature system codes for IVD medical devices for the purposes of section 41BE(3) of the Act

ISO 15189 - Medical laboratories - Particular requirements for quality and competance

Therapeutic Goods Regulations 1990

Development and Use of In-house In Vitro Diagnostic Devices (IVDs)