TGA presentation: Lifecycle of a Medical Device / IVD
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An overview of the lifecycle of a medical device/IVD
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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
- 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.
- 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.