Presentation: Application for consent to import, supply or export unapproved medical devices that are non-compliant with the Essential Principles

Background

Vaping devices must comply with either the Essential Principles (EPs) or Therapeutic Goods (Medical Device Standard - Therapeutic Vaping Devices) Order 2023 (MDSO) before being lawfully supplied in Australia.

There may be circumstances in which a sponsor is unable to meet the requirements of one or more Essential Principles for a period of time. If you are a sponsor of a vaping device that wants to import, supply or export a vaping device that is non-compliant with the EPs you will need to apply for consent.

The consent for non-compliance application form has been updated to allow sponsors of vaping devices to request consent to supply non-included goods that do not comply with the Essential Principles. There is no ability to apply for a consent to supply that does not meet the MDSO.

The aim of the webinar is to provide an overview of the updated sponsor portal and provide guidance on how to apply for consent for unapproved medical devices in the sponsor portal in the Consent for Non-compliance Dashboard in the TGA Business Services (TBS) sponsor portal.

Speaker

Racheal Aye, A/g Assistant Director, Medical Devices Surveillance Branch, TGA

Slides