Online Survey: Consent to import, supply or export a medical device that does not comply with the Essential Principles

From 1 December 2021, the way in which sponsors submit an application for consent to import, supply, or export a medical device that is non-complaint with the Essential Principles changed from a paper version to an electronic form hosted in the TGA Business Services portal (TBS). The TGA requested sponsor feedback on this new application process through a survey on the TGA Consultation Hub.

The survey was open for feedback for 12 months, from 1 December 2021 to 1 December 2022.

There were no submissions received through the TGA Consultation Hub. However, stakeholders provided feedback through other channels such as the Regulatory and Technical Consultative Forum for medical devices (RegTech Forum). Sponsors requested additional save and print functionalities.  

In response to the feedback received, the TGA introduced additional save and print functionalities for both draft and submitted forms.

The TGA will continue to implement reforms to improve regulatory processes for sponsors of medical devices.