TGA issues guidance on regulation of medical apps

The Therapeutic Goods Administration (TGA) has issued a guidance paper on its responsibilities in regulating medical software and mobile medical apps.

The TGA said the guidance was issued to address questions frequently put to the agency, saying software is becoming increasingly important in medical devices and its rapid evolution presented new and complex challenges for regulatory agencies internationally.

In addition to pharmaceuticals, the agency administers the Therapeutic Goods Act 1989, which defines what a medical device is.

For medical software to be considered a medical device, it has to fit the definition in section 41BD of the act. Medical devices are those that are used for diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability, as well as anatomical devices such as hip replacements and IUDs.

According to the TGA, software that satisfies this definition may include programs or operating instructions that control the functioning of an electronic device. This includes smartphone apps that measure blood glucose levels and body temperature, x-ray image-processing software and diagnostic software.

However, not all forms of 'medical software' come within the definition of a medical device, the TGA said.

“A software product that is limited to managing and presenting information – such as a medical records management system or a dosage calculator – would not usually come within the definition unless it also incorporates a therapeutic or diagnostic function.”

The agency said many mobile apps are simply sources of information and the TGA does not have a role in regulating advice to health professionals or consumers other than when it relates to the advertising of therapeutic goods, or labelling and instructions for use.

“However, products that have a role in diagnosing or managing illness using software that analyses clinical data, such as the results of blood tests or ECGs, would, if they come within the definition above, be considered to be medical devices and would therefore be subject to TGA's regulatory oversight,” it said.

“The TGA already regulates medical device software used for therapeutic purposes under the medical devices regulatory framework. Mobile apps would be considered within this framework.”

It said the regulation of medical device software and mobile medical apps is risk-based. “This means that the level of scrutiny and oversight by the TGA applied to a product will vary according to the level of risk that the product represents to the patient or healthcare professional using it.”

This year, the International Medical Device Regulators Forum (IMDRF), of which the TGA is a founding member, set up a working group to develop and harmonise approaches to the regulation of mobile medical apps. The TGA said it was actively participating in this working group.

Posted in Australian eHealth

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