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Background
TGA is redeveloping the conformity assessment application form to enable applicants to provide all the required information at the time of submitting their application.
Instead of receiving a request to complete the Supporting Data Form and provide the technical dossier to TGA via courier or email, applicants will enter the supporting data directly into the application form and electronically attach the dossier to the application form.1
A feature of the new application form will be the pre-population of certificate details when a certificate is selected for a change or re-certification. Initially the details populating the form will be the details currently presented on a certificate:
- Manufacturing sites including facility name and address details and facility scope
- Critical suppliers including address and supplier scope details
- Device category and UPI details
To enable this functionality, a new data repository is being established to aid the management of TGA issued conformity assessment certificates. The initial data load of the repository will be all currently active certificates including all the certificate details as they appear on the certificate. As certificates are selected for changes and recertification, the additional application information that the applicant enters into the eForm, such as device specific details and overseas certification, will also be stored for each certificate in the repository. This will enable more information to pre-populate the application form in future applications. This will mean that an applicant will only have to indicate what is to change, be added or deleted of the existing stored data when submitting a future application.
Why we are contacting you
TGA is introducing a level of security on the new application form to ensure the privacy of your certificate details is restricted to only organisations you have authorised to access your conformity assessment certificates. The current application form allows the applicant to search and select any manufacture for the application. As the new application form will pre-populate certificate details, the form must restrict the applicant to only a list of manufacturer(s) that have authorised them for conformity assessment applications. The application form will not allow an unauthorised organisation to access any conformity assessment certificate information if the manufacturer has not authorised that organisation to do so.
Our intent is to create an 'agent for a manufacturer' similar to the 'agent for a sponsor' concept used for other regulatory application forms. A manufacturer may authorise one or more other organisations to be their agent for conformity assessment purposes. The relationship will be managed in the client relationship management system and be administered by the TBS help desk.
What you are required to do
TGA is requesting that you as a conformity assessment manufacturer authorise agents by performing the following steps:
- Complete the request form Add a connection to your manufacturing organisation for each organisation you want to authorise for conformity assessment applications
- The declaration of the form must be completed by an authorised signatory of the manufacturing organisation
- Email each completed form to the TBS help desk ebs@tga.gov.au.
- Inform your agent organisations that you have requested TGA to create an agent relationship with your organisation to be set-up in the client database
- This relationship will also enable your agent organisations to view your data as displayed under "Your TGA Information" on the TBS portal.
Your organisational details held by TGA
TGA is encouraging clients to manage their organisational details held by TGA via the TBS self-service portal.
In the future, you must ensure your address and contact details are current and up to date within the TGA client database to ensure these details are available for selection on the conformity assessment application form. Currently these details are provided within the Supporting Data Form, the new application form will prompt the applicant to make a selection from details sourced from the TGA client database for the manufacturer's organisational record. Applicants will no longer be able to enter 'free text' for manufacturer address and contact details.
Footnote
- If the dossier is within the 1MB size limit
Add or remove a connection to your manufacturing organisation form
How to access a pdf or Word document
This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.