TGA launches regulatory reforms for software as a medical device


By Mardi Chapman

13 Mar 2019

The TGA has outlined it plans to regulate medical mobile apps that have functions similar to medical devices such as blood glucose monitoring, performing ECGs and interpreting images.

The regulator has opened up consultation on the regulation of medical device software, including software that functions as a medical device in its own right (SaMD). It says the existing regulatory framework for medical devices does not adequately cover standalone software, including smartphone apps, that can monitor, diagnose or treat disease.

In particular, the TGA has noted that anyone in Australia can now download powerful software with device-like functionality from app stores, bypassing oversight by the Australian Register of Therapeutic Goods (ARTG).

“SaMD that is not included in the ARTG does not undergo any scrutiny of its supporting evidence including the certification of the manufacturer where required. In addition, it cannot be monitored for ongoing safety, quality and performance; and post-market actions such as recalls or suspension cannot be enforced where necessary for public health and safety.”

“With the easy access to technology today, millions of Australians could be downloading and using a SaMD product. The personal importation provisions were not intended to enable the importation of therapeutic goods in large volumes without TGA oversight.”

Proposed regulatory changes include:

  • SaMD to be classified according to the potential harm they could cause.
  • SaMD to be included in the ARTG and excluded from the personal importation provisions.
  • Overseas products to have an Australian sponsor.
  • Requirements for demonstrating safety and performance of all software.

The TGA said software that calculates medicine doses or apps that purport to make a diagnosis of melanoma based on AI or machine learning of skin lesion images were examples of SaMD that present a moderate or high risk to consumers.

“Such devices should be subject to third party oversight that is commensurate with the risk they represent to patients,” the TGA said in its background document.

It said any changes will ‘where possible’ be in line with international best practice.

General health and lifestyle apps are not included in the regulatory reform.

Consultation closes 31 March 2019


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