lifecycle of a medical device / ivd · complaints, literature, user experience . adverse event...
TRANSCRIPT
![Page 1: Lifecycle of a Medical Device / IVD · Complaints, Literature, user experience . Adverse Event Reporting . Application Audit . Ongoing Reports, ... Market Complaints, and Supply](https://reader034.vdocuments.site/reader034/viewer/2022042221/5ec71aa058af25327f502806/html5/thumbnails/1.jpg)
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Lifecycle of a Medical Device / IVD
Speaker ― Sally Jennings Chair, TARSC, IVD Australia
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Disclaimer
Any comments, issues, actions or decisions described in or with this presentation DO NOT in any way reflect on any device currently or
previously supplied on the market. Examples used DO NOT imply any action or decision on the part of
any sponsor, manufacturer or the TGA.
![Page 4: Lifecycle of a Medical Device / IVD · Complaints, Literature, user experience . Adverse Event Reporting . Application Audit . Ongoing Reports, ... Market Complaints, and Supply](https://reader034.vdocuments.site/reader034/viewer/2022042221/5ec71aa058af25327f502806/html5/thumbnails/4.jpg)
Clinical Evidence
Design, Develop, Validate Re-Engineer/
Reformulate Approval of Conformity
Product Recall/
Correction Incident/ patient impact
Market and Supply
Advertising Promotion
Complaints, Literature, user
experience Adverse
Event Reporting
Application Audit
Ongoing Reports, TGA audits
Uniform Recall
Procedure
Notification of Change
Application for Inclusion
Manufacturers Evidence
Conformity Assessment
ARTG
ACMD
Code
Lifecycle of a Medical Device / IVD
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Example Medical Devices
Class III Medical Device Contains human &/or animal origin material
Class I IVD Medical Device/ Class IIb Medical Device
Self-testing
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Pre-Market
Clinical Evidence
Design, Develop, Validate
Approval of Conformity
Conformity Assessment
ACMD
Class III Medical Device Contains human &/or animal origin material
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Pre-Market
Clinical Evidence
Approval of Conformity
Advertising Promotion Application
Audit
Application for Inclusion
Manufacturers Evidence
ARTG
Code
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Post-Market
Clinical Evidence
Market and Supply
Advertising Promotion
Complaints, Literature, user
experience
Ongoing Reports, TGA audits
ARTG
Code
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Lifecycle of a Medical Device / IVD
Clinical Evidence
Incident/ patient impact
Market and Supply Complaints,
Literature, user experience
Adverse Event
Reporting Ongoing Reports, TGA audits
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Post-Market
Clinical Evidence
Product Recall/
Correction
Uniform Recall
Procedure
IMPORTANT SAFETY INFORMATION Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj.
WARNING: Do not wear sensor longer than the time indicated in these instructions for use. Doing so may cause adverse skin reactions. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj.
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Post-Market
Clinical Evidence
Design, Develop, Validate Re-Engineer/
Reformulate Approval of Conformity
Notification of Change
Conformity Assessment
ACMD
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Clinical Evidence
Clinical Evidence
Design, Develop, Validate Re-Engineer/
Reformulate Approval of Conformity
Product Recall/
Correction Incident/ patient impact
Market and Supply
Advertising Promotion
Complaints, Literature, user
experience Adverse
Event Reporting
Application Audit
Ongoing Reports, TGA audits
Uniform Recall
Procedure
Notification of Change
Application for Inclusion
Manufacturers Evidence
Conformity Assessment
ARTG
ACMD
Code
![Page 13: Lifecycle of a Medical Device / IVD · Complaints, Literature, user experience . Adverse Event Reporting . Application Audit . Ongoing Reports, ... Market Complaints, and Supply](https://reader034.vdocuments.site/reader034/viewer/2022042221/5ec71aa058af25327f502806/html5/thumbnails/13.jpg)
Disclaimer
Any comments, issues, actions or decisions described in or with this presentation DO NOT in any way reflect on any device currently on the market. Nor do they imply any action or decision on the part of
any sponsor, manufacturer or the TGA.
![Page 14: Lifecycle of a Medical Device / IVD · Complaints, Literature, user experience . Adverse Event Reporting . Application Audit . Ongoing Reports, ... Market Complaints, and Supply](https://reader034.vdocuments.site/reader034/viewer/2022042221/5ec71aa058af25327f502806/html5/thumbnails/14.jpg)