Australia seeks comment on unapproved, exempt devices
This article was originally published in Clinica
The Australian regulator has issued for stakeholder comment a draft document that provides information on accessing unapproved devices, and on when devices are exempt from inclusion in the Australian Register of Therapeutic Goods. When finalised, the guidance, entitled "Access to unapproved medical devices in Australia", will form part of the under-review Australian Regulatory Guidelines for Medical Devices (ARGMD), which are expected to be ready by the end of the calendar year. For further information and to submit comments, go to http://www.tga.gov.au/devices/argmd.htm
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