TGA presentation: Lifecycle of a Medical Device / IVD

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TGA Australia

An overview of the lifecycle of a medical device/IVD

Lifecycle of a Medical Device / IVD
Speaker ―
Sally Jennings
Chair, TARSC, IVD Australia

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.

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

Example Medical Devices
Class III Medical Device
Contains human &/or
animal origin material
Class I IVD Medical Device/
Class IIb Medical Device
Self-testing

Pre-Market
Clinical
Evidence
Design,
Develop,
Validate
Approval of
Conformity
Conformity
Assessment
ACMD
Class III Medical Device
Contains human &/or
animal origin material

Pre-Market
Clinical
Evidence
Approval of
Conformity
Advertising
Promotion
Application
Audit
Application for
Inclusion
Manufacturers
Evidence
ARTG
Code

Post-Market
Clinical
Evidence
Market
and Supply
Advertising
Promotion
Complaints,
Literature, user
experience
Ongoing Reports,
TGA audits
ARTG
Code

Lifecycle of a Medical Device / IVD
Clinical
Evidence
Incident/
patient
impact
Market
and SupplyComplaints,
Literature, user
experience
Adverse
Event
Reporting Ongoing Reports,
TGA audits

Post-Market
Clinical
Evidence
Product
Recall/
Correction
Uniform
Recall
Procedure
IMPORTANT SAFETY INFORMATION
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Post-Market
Clinical
Evidence
Design,
Develop,
Validate
Re-Engineer/
Reformulate
Approval of
Conformity
Notification
of Change
Conformity
Assessment
ACMD

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

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.

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TGA presentation: Lifecycle of a Medical Device / IVD

2. Lifecycle of a Medical Device / IVD Speaker ― Sally Jennings Chair, TARSC, IVD Australia

3. 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.

4. 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

5. Example Medical Devices Class III Medical Device Contains human &/or animal origin material Class I IVD Medical Device/ Class IIb Medical Device Self-testing

6. Pre-Market Clinical Evidence Design, Develop, Validate Approval of Conformity Conformity Assessment ACMD Class III Medical Device Contains human &/or animal origin material

7. Pre-Market Clinical Evidence Approval of Conformity Advertising Promotion Application Audit Application for Inclusion Manufacturers Evidence ARTG Code

8. Post-Market Clinical Evidence Market and Supply Advertising Promotion Complaints, Literature, user experience Ongoing Reports, TGA audits ARTG Code

9. Lifecycle of a Medical Device / IVD Clinical Evidence Incident/ patient impact Market and SupplyComplaints, Literature, user experience Adverse Event Reporting Ongoing Reports, TGA audits

10. Post-Market Clinical Evidence Product Recall/ Correction Uniform Recall Procedure IMPORTANT SAFETY INFORMATION Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsj nfdsjnfdjasndsjnjdsnfj. WARNING: Do not wear sensor longer than the time indicated in these instructions for use. Doing so may cause adverse skin reactions. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsj nfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsj nfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsj nfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsj nfdsjnfdjasndsjnjdsnfj.

11. Post-Market Clinical Evidence Design, Develop, Validate Re-Engineer/ Reformulate Approval of Conformity Notification of Change Conformity Assessment ACMD

12. 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

13. 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.

TGA presentation: Lifecycle of a Medical Device / IVD

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