Online Survey: Consent to import, supply or export a medical device that does not comply with the Essential Principles
Feedback updated 25 Sep 2023
We asked
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.
You said
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.
We did
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.
Overview
From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to the TGA.
The purpose of this survey is to seek your feedback on the new application form.
Audiences
- Aboriginal and Torres Strait Islander People
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