Brachytherapy kits (regulatory status)

8 October 2010

The TGA is aware of recent interest in the regulatory status of brachytherapy kits.

There are three such kits included on the Australian Register of Therapeutic Goods (ARTG), the VariStrand Needle System from MD Solutions, the Oncura Oncoseed Sterile Convenience Pack, and the Advantage Strand/Advantage Load Brachytherapy Kit, sponsored by CMS Alphatech. The components of the Oncura RapidStrand Rx Brachytherapy Kit are also included on the ARTG, but the kit itself, which consists of a configuration of seeds and spacers pre-loaded to the medical practitioner's requirements, is custom-made and therefore exempt from the requirement for entry on the ARTG, although nevertheless legally supplied.

A custom made medical device is defined in the Therapeutic Goods (Medical Devices) Regulations 2002 as "a medical device that is specifically made in accordance with a request by a health professional specifying the design characteristics or construction of the medical device, and is intended to be used only in relation to a particular individual". Medical device kits are regulated as medical devices.