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Source: Australian Department of Health

Changes to the process for responding to post market reviews

From 19 October 2020, the process by which the Therapeutic Good Administration (TGA) engages with sponsors will change. A new Post Market Review Compliance Dashboard has been developed to replace the existing process of responding to a post-market review and sending associated documentation by email to the TGA.

Summary of changes

  • Sponsors will be able to directly respond to post-market reviews in the new dashboard that can be accessed through TBS.
  • The new dashboard provides an efficient and secure way of responding to post-market reviews and storing the information in a central location. This will also make it easier to access reviews (active and closed) and remove the need to resend information to different teams at the TGA as they will have access to this information in the dashboard.
  • The dashboard has the capability to upload relevant files up to 15GB (per file) size and removes the need to send files via the Cloud, email or sending USBs.

Implementation

  • If you are sent a notification, as part of a post-market review, prior to 19 October 2020, please follow the instructions outlined in the review letter on how to respond. This will generally be by email to postmarketdevices@health.gov.au.
  • If you are sent a notification, as part of a post-market review, post 19 October 2020, you will be required to use the new dashboard in TBS to respond to the notification, as outlined in the letter or email that is sent to you.
  • All reviews, open and closed, can be accessed in the Post Market Review compliance dashboard.
  • A Post Market Review Compliance Dashboard Reference Guide for step-by-step instructions on how to use the new dashboard and respond to notifications, including requests for information, proposals to cancel or suspend, or conditions of inclusion notifications will be published on this web page by 19 October 2020.
  • If you have further questions relating to the new portal, please email the Medical Devices Branch on postmarketdevices@health.gov.au.

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