Changes affecting TGA-issued conformity assessment certificates

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The purpose of this guidance is twofold:

  1. To assist manufacturers in assessing whether proposed changes to a conformity assessment certificate amount to 'substantial changes' and if so, what the manufacturers' obligations are for the purposes of meeting the automatic conditions on a conformity assessment certificate and the requirements of the conformity assessment procedures.
  2. To set out the events that trigger the transfer of a conformity assessment certificate and its associated responsibilities to a new entity (i.e. a new manufacturer).

This is a guide only. Sponsors and manufacturers are encouraged to seek independent professional advice to ensure they comply with their legislative and regulatory requirements under the therapeutic goods legislation. This document will evolve over time. Updates and clarifications will be included as required. Feedback on the guidance is always welcome.

This guidance is for manufacturers that have been issued conformity assessment certification by the Therapeutic Goods Administration (TGA) and are planning to make a change. This guidance also includes events that trigger a transfer of a conformity assessment certificate, and its associated responsibilities, to a new entity.

  • 1. Compliance with conformity assessment procedures and ‘substantial changes’ condition on TGA certificates
  • 2. What is considered to be a substantial change?
  • 3. How to notify the TGA of a substantial change
    • 3.1 Method for notification and application for a substantial change 6 What happens after submission?
  • 4. Tools to determine substantial changes
    • 4.1 Changes to Quality Management Systems
    • 4.2 Changes to product design
    • 4.3 Changes to the information to be provided with medical devices, including IVD medical devices
  • 5. What is not considered a substantial change
  • 6. Transfers of conformity assessment certificates
    • 6.1 Events that trigger a transfer
    • 6.2 When does the transfer actually take place?
    • 6.3 Method for notification and application for a certificate transfer
  • Appendix A: Examples of substantial changes
  • Appendix B: Examples of changes that do not require an application for substantial change
  • Appendix C: Examples of certificate transfers
Publication Date: 
Thursday, August 19, 2021 - 12:00pm
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Subtitle: 

Guidelines for notifying the TGA about ‘substantial changes’ to, or transfers of, conformity assessment certificates

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