TGA introduces new Class I Device application Fee, plus general 1.9% increase.

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TGA introduces new Class I Device application Fee, plus general 1.9% increase.

In a long-anticipated change, TGA today announced the introduction of a new $530 application fee for Class I medical devices and an overall increase of 1.9% to most other TGA fees.

Currently TGA Class I applications are free of charge. However they do require effort from TGA to maintain the electronic systems for processing the applications, and for ongoing review of submissions to weed out those which are incorrectly filed (usually higher risk devices incorrectly filed as Class I).

TGA recovers all of their costs from industry and in effect, the cost of management of the Class I inclusions has been cross-subsidised by those paying fees on higher risk devices.  So TGA has costed this out and from 1 July 2018, TGA will introduce a new $530 application fee for all Class I Inclusions.

The general annual fee increases also include an increase from $80 – $90 for Class I annual charges. The increases will commence on 1 July 2018. See the TGA website for the new fees and charges schedule.

Class I inclusions are granted automatically and easy to obtain. So they tend to be neglected by their owners. This new fee will make applicants more careful and thoughtful. Ask yourself if your Class I inclusions are up to date, still required and accurate. Perhaps it’s time to clean house?


Help button-Quick Call-Brandwood BiomedicalNeed help with TGA regulatory compliance?  We are experienced in all aspects of TGA regulatory regulations – including using international data to gain Australian registration.  Contact us for a free, no obligation discussion.  Email help@brandwoodbiomedical.com or call us:

1 888-271-5063 (US toll free)    ♦   400-842 7017 (Beijing – toll free)   ♦    +61 2 9906 2984 (Sydney)

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