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Application for TGA conformity assessment certificates (medical devices)

Guidance and forms relating to applications for a TGA-issued conformity assessment certificate.

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Note

In most cases, there are options for the types of regulatory evidence you can use in support of your sponsor’s application to include your device in the Australian Register of Therapeutic Goods.  Your choice will, in large part, be a business decision. Further information is available at Supporting documentation for inclusion of a medical device and Obtain and maintain regulatory evidence.

Guidance

This document provides guidance on how to apply for a TGA conformity assessment certificate.

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.

Forms

As part of the application process, the applicant is required to provide the 'Supporting data form' together with the supporting data of an application. The applicant should use either the single Word version of the form OR the PDF version of the form with additional form pages as required.

Conformity assessment certification - supporting data form

Additional pages

Note: The 'supporting data form' must only be provided to the TGA with the supporting data of the application after the applicant receives the acknowledgment email from the TGA for the lodged application in eBusiness Services. Only current forms will be accepted. Additional pages (e.g., for several facilities, devices, etc.) can be used as required.

Additional section 3.3: Manufacturer facility (site) details

Additional section 4: Critical supplier's details

Additional section 5: Device details - non-IVD devices only

Additional section 6: IVD device details

Additional attachment 1 - New certificate checklist

Additional attachment 2 - Substantial change checklist

Additional attachment 3 - Recertification checklist

Note - 20 November 2020

The electronic application form for a Conformity Assessment Certificate has been updated.

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