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Australian Government
Department of Health
Therapeutic Goods Administration
Examples of regulated and
unregulated software (excluded)
software based medical devices
Version 1.2,August 2021
Health Safety
Regulation
2D
356C 91B6D04D13155230A
EF⁸895262B127905DE65
0EAF3F5463B6EBED9DC
158948546354D3EE550
575B144F068 A6409580
3C04E4136C4FF07R
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TGA'
Therapeutic Goods Administration
Copyright
C Commonwealth of Australia 2021
This work is copyright.You may reproduce the whole or part of this work in unaltered form for your own personal use or,if
you are part of an organisation,for internal use within your organisation,but only ifyou oryour organisation do not use the
reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of thatt
reproduction.Apart from rights to use as permitted by the Copyright Act1968 or allowed by this copyright notice,all other
rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or
otherwise)without first being given specific written permission from the Commonwealth to do so.Requests and inquiries
concerning reproduction and rights are to be sent to the TGA Copyright Officer,Therapeutic Goods Administration,PO Box
100,Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.
The purpose of this guidance is to help manufacturers and sponsors understand how the TGA
interprets requirements,and thus indicate how manufacturers and sponsors can comply.
This is a guide only,and manufacturers and sponsors are encouraged to familiarise themselves
with the legislative and regulatory requirements in Australia,and if necessary,to seek
professional advice.It is the responsibility of each manufacturer or sponsor to understand and
comply with these requirements.
Examples of regulated and unregulated software (excluded)software based medical devices Page 2 of 21
Version 1.2,August 2021
TherapeuticGoodsAdministration
Contents
About this guidance_ 4
Regulatory changes for software ........... …………………………………………………………4
Walkthrough examples _ 5
Is the software intended to be used for a medical purpose? ....................... 5
Does the software meet the exclusion criteria ?_ -5
Example 1: Kilojoulecounter 7
Example 2: Software for tracking health information _ 7
Example 3: Software that is used todiagnosehypertension and risk of
cardiac disease_ 7
Example 4: Software that controls an insulin pump_ 8
Examples of excluded software_ 8
Examples of regulated software 9
Class I_ .................................... 10
Neural network for monitoring shingles ................................................................... 10
Other Class I examples ..................................................................................................... 10
Class Ila_ ....................................................................................................... 10
Cardiac MRI analyser ..................................................... Error!Bookmarknotdefined.
Other Class Ila examples ................................................................................................... 10
Class IIb_ .................................................................................................. 11
Cardiac MRI analyser ....................................................................................................... 11
Heart valve screening ................................................... Error!Bookmarknotdefined.
Diagnosis of acute arterial occlusion ......................................................................... 11
Recommendation of a treatment or intervention ................................................. 11
Other Class IIb examples ................................................................................................... 11
Class III .............................................. 12
Specifies a treatment or intervention ...........................................................................12
Other Class II examples ................................................................................................... 12
Excluded software versus regulated software ....................... 12
Clinical decision support software ....................... -18
Examples ofregulated and unregulated software (excluded) software based medical devices Page 3 of 21
Version 1.2, August 2021
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作者：冒牌货
分类：法规规范
价格：50质量币
属性：25 页
大小：546.23KB
格式：PDF
时间：2026-01-09
