Australia releases guidance on Class III devices and active implantables:
This article was originally published in Clinica
Executive Summary
Australia's Therapeutic Goods Administration (TGA) has published "Australian Medical Devices Guidance Document 13 - variants for Class III and AIMD Medical Devices", which addresses the criteria for entering Class III and active implantable medical devices in the Australian Register of Therapeutic Goods (ARTG). It covers "same kind of medical device", unique product identifiers and variants. The document is one of a series explaining key areas of the new regulatory system for medical devices. The guidance is available via: www.tga.gov.au/new/new.htm
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