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The electronic application form for a Conformity Assessment Certificate that is accessible via the TGA Business Services (TBS) portal has been updated.
What are the updates to the application form?
The updates to the electronic application form for a Conformity Assessment Certificate are detailed in the table below.
| Previous form | Updated form |
|---|---|
Application Type This application is for a:
| Application Type This application is for a:
|
Device Details For Australian or NZ manufacturers, is CE certification in accordance with the EU Medical Devices Directives sought?
| Device Details For Australian manufacturers, is CE certification in accordance with the EU Medical Devices Directives sought?
|
What do the updates mean?
In the updated electronic form, the options field beneath 'Application Type' has been amended to improve clarity for manufacturers in relation to their legislative obligation to notify the TGA when making substantial changes to their Conformity Assessment Certificate. A new option for recertification applications has also been created.
This means that in the updated form, manufacturers or applicants will need to select:
- Initial application when applying for an initial assessment of the manufacturer's quality management system or for a new kind of device including an in-vitro diagnostic device. This replaces the 'New conformity assessment certificate(s)' option in the previous electronic form.
- Substantial change notification and application when making an application for a change to an existing Conformity Assessment Certificate. This includes notification of any plan for substantial changes to the quality management systems; the product range covered by those systems; or the product design of kinds of medical devices. This option will replace the 'Change to an existing certificate(s)' option in the previous electronic form.
- Recertification of an expiring certificate when applying for recertification of a Conformity Assessment Certificate. This option was not available in the previous electronic form.
The other update includes removal of the reference to NZ manufacturers in the context of CE certification beneath the Device Details section of the form, in accordance with the EU Medical Devices Directives. Under the European Community - Australia Mutual Recognition Agreement (EC-MRA), the TGA can only to issue a CE certificate under MRA to Australian manufacturers.