Blog
RSS FeedPosted by Michael Wonder on 09 Mar 2020
Reformatting Product Information: frequently asked questions
6 March 2020 - A new product information form was approved on 8 November 2017, with a commencement date of ...
Posted by Michael Wonder on 09 May 2018
Outcomes of the consultation on the draft list of permitted indications
8 May 2018 - On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under Section ...
Posted by Michael Wonder on 21 Feb 2018
Mandatory requirements for an effective application
21 February 2018 - Applicable for applications lodged from 9 February 2018. ...
Posted by Michael Wonder on 28 Feb 2017
Clinical evidence guidelines documents for medical devices
28 February 2017 - This document is intended to provide guidance to manufacturers of medical devices (including in vitro diagnostic ...
Posted by Michael Wonder on 15 Mar 2016
Draft clinical evidence guidelines - medical devices
15 March 2016 - The TGA is seeking comments from interested parties on the draft Medical Devices Clinical Evidence Guidelines. ...