Lifecycle of a Medical Device / IVD Speaker Sally Jennings Chair, - PowerPoint PPT Presentation

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.

Lifecycle of a Medical Device / IVD ACMD Conformity Assessment Notification Manufacturers of Change Evidence Design, Develop, Approval of Re-Engineer/ Application for Validate Uniform Conformity Reformulate Inclusion Recall Product Code Procedure Advertising Clinical Application Recall/ Promotion Evidence Audit Correction Incident/ Market patient and Supply Complaints, impact ARTG Literature, user Adverse experience Event Reporting Ongoing Reports, TGA audits

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

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

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

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

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

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

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

Clinical Evidence ACMD Conformity Assessment Notification Manufacturers of Change Evidence Design, Develop, Approval of Re-Engineer/ Application for Validate Uniform Conformity Reformulate Inclusion Recall Product Code Procedure Advertising Clinical Application Recall/ Promotion Evidence Audit Correction Incident/ Market patient and Supply Complaints, impact ARTG Literature, user Adverse experience Event Reporting Ongoing Reports, TGA audits

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.