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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs

Version 1.0, November 2011

24 November 2011

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Changes to current certificates

If any of the details on a TGA Conformity Assessment Certificate are no longer correct, the manufacturer must notify the TGA. Changes include:

  • changes to details on the certificate (e.g. name and/or address details)
  • adding new devices
  • changing details on the Schedule of Suppliers
  • substantial modifications to the design of, or production processes for, an existing device.

The manufacturer needs to submit an application to the TGA. Applications for changing an existing TGA Conformity Assessment Certificate should be lodged electronically using the eBusiness system. The application should indicate the existing certificate number that needs to be changed and the change required on the certificate.

Details of the fees payable for changing a TGA Conformity Assessment Certificate are available at Summary of fees and charges at 1 July 2011.

The TGA will need to conduct an assessment of the documentation submitted with each application for a change and further evidence to support the change may be required before a new certificate is issued.

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