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.

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

• f 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 Supply Complaints, 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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WARNING: Do not wear sensor longer than the time indicated in these instructions for use. Doing so may cause adverse skin reactions.

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Post-Market

Clinical Evidence

Design, Develop, Validate Re-Engineer/ Reformulate Approval of Conformity Notification

• f 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

• f 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.