TGA Update on Medical Device Reforms

Join the webinar, hosted by CHF in partnership with the Therapeutic Goods Administration (TGA).

During 2019, the Therapeutic Goods Administration (TGA) will continue to implement changes in response to the Review of Medicines and Medical Devices Regulation (MMDR). Currently the Medical Devices Branch of the TGA has five consultations open for submissions.

This webinar aims to update consumers on these medical device consultations and answer questions from consumers. The presenters will be:

-          Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division; and

-          Dr Elizabeth McGrath, Director Devices Conformity Assessment, Medical Devices Branch

Participants can see the five current TGA Consultations at:

•      Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

•      Medical device cyber security

•      Potential reclassification of active medical devices for diagnosis and patient therapy

•      Changes to a number of definitions and scope of the medical device regulatory framework in Australia

•      Review of Therapeutic Goods Order 54 – Standards for Disinfectants; and associated guidance