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TGA - Low Risk Working Group ARATA Representation

Thursday 01, Nov 2018

The aim of the meeting was to “provide advice on which products are to be part of the Therapeutic Goods (Excluded Goods) Determination under section 7AA of the "Therapeutic Goods Act 1989”. This aim included improving clarity, to help establish guiding principles and to provide advice on specific products. This follows a recommendation in 2015 of the Expert Review of Medicines and Medical Devices, which urged “a review of products currently classified as Class I medical devices, with a view to reclassifying products as consumer goods in circumstances where the product poses little or no risk to consumers should it not perform as specified or malfunctions” and subsequent public consultation.


The Working Group discussed a range of products, seeking to identify those which could be more appropriately considered as consumer goods and not medical devices, and which therapeutic goods classified as medical devices could be considered “low risk” and be excluded from the system.  The attached chart shows the flow of the regulatory scheme - click here to view


I noted that the definition of “medical device” depends substantially on the claims or intended purposes of the item by the supplier/manufacturer, not the product itself. Even if an item is a Therapeutic Good and a Medical Device, it may be excluded from the regulatory system is it is considered to be very low risk.


I was mainly able to contribute in areas where I had some experience (computer-related AT) and where common sense and clear thinking were useful. Involvement was useful and I feel my contribution was appreciated.


Dr Graeme Smith