Australia's Therapeutic Goods Administration (TGA) issued guidance on 13 September 2013 on the regulatory arrangements pertaining to medical software and mobile medical apps by addressing questions frequently asked of the agency.

Applications for inclusion of medical device software in the Australian Register of Therapeutic Goods (ARTG) are reviewed in accordance with the manufacturer's intended purpose and the manner in which the product is to be supplied to health care professionals and the Australian public. The therapeutic goods legislation requires manufacturers of medical device software products (other than those which are classified as Class 1, the lowest risk classification) to obtain Conformity Assessment certification, while all medical devices, irrespective of classification, are expected to meet the Essential Principles for safety and performance.

The TGA said it may update the guidance in the near future in light of the recommendations developed by the International Medical Device Regulators Forum (IMDRF) Working Group tasked with developing and harmonizing approaches to the regulation of standalone medical device software (including mobile medical apps). 

 

TGA Guidance on Medical Apps

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