TGA's New Post Market Review Compliance Dashboard

Closes 31 Dec 2021

Opened 8 Nov 2020

Overview

From 19 October 2020, how the TGA engages with the sponsors for post market reviews has changed. A new medical device Post Market Review Compliance Dashboard  has been developed in TBS to respond to post market reviews. The new compliance dashboard will provide the sponsors with an efficient and secure way of responding to post market reviews.

The purpose of this survey is to seek your feedback on the new Post Market Review Compliance Dashboard. 

Why we are consulting

In the TGA's new medical device  Post Market Review Compliance Dashboard, the sponsors will be able to directly respond to post market reviews. The sponsors will receive regulatory requests for information via email and directed to the dashboard through TBS in which they will find new requests for information, submitted requests for information and any requests for information that they have saved but not yet submitted. The sponsors will also be able to upload and submit large files for the post market reviews. Therefore reducing the need to send in information on USB or CD’s and eliminating the risk of these devices getting lost or not being received. 

We invite you to provide your feedback on the new Post Market Review Compliance Dashboard by completing our online survey (click on the link below).

Audiences

  • Medical Devices & IVDs
  • Other

Interests

  • Information Technology
  • Strategic Policy
  • Policy Development