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.
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.