Regulation of medical software and mobile medical ‘apps’ – TGA – 13 September 2013

Posted on September 17, 2013. Filed under: Health Informatics, Health Technology Assessment | Tags: , |

Regulation of medical software and mobile medical ‘apps’ – TGA – 13 September 2013

“Software is becoming increasingly important in medical devices; however, its rapid evolution, particularly in relation to mobile technology, presents new and complex challenges for the TGA and regulatory agencies internationally.

The following is intended to provide guidance on the regulatory arrangements pertaining to medical software and mobile medical apps by addressing some questions frequently put to the Therapeutic Goods Administration (TGA).

Are medical software products considered to be medical devices?

A software product is considered a medical device if it fits the definition in section 41BD of the Therapeutic Goods Act 1989.”

… continues on the site

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