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Guidance for consent application form on the TGA Business Services (TBS) portal
This document provides guidance on how to successfully complete and submit an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles (EPs).
The TGA has modernised the consent application process, moving from a paper form to an online form. The new form, hosted in the TGA Business Services (TBS) portal will streamline the application process and allow for greater functionality, including the ability for sponsors to view their current and previous applications for consent.
There are criminal offences under section 41MA and civil penalties under section 41MAA of the Therapeutic Goods Act 1989 (the Act), for importing, supplying, or exporting medical devices that do not meet the Essential Principles (EPs) for safety and performance, unless consent has been granted by the Secretary of the Department of Health.
The TGA expects compliance with the EPs, however there may be some extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time.
- Multiple devices included in one application
- Application / Processing Fees
- The application form
- Start a new application
- Application details section
- Non-compliant Essential Principles
- Device groups
- Viewing the status of submitted applications
- Viewing and printing submitted applications
- Questions and answers
- Version history
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