On 13 September 2013, the Therapeutic Goods Association (TGA) published guidance about Australia's regulatory arrangements for medical software and mobile medical 'apps' on its website.

The TGA first undertook to regulate medical software and apps in 2011, after the United States Food and Drug Administration released draft guidelines on the issue. This is the first time that the TGA has published formal regulatory guidance about medical software and medical apps.

WHAT MEDICAL SOFTWARE DOES THE TGA REGULATE?

Medical software is regulated by the TGA as a "medical device" under Chapter 4 of the Therapeutic Goods Act 1989 (Cth) (the Act).

Generally, medical device software that is intended to control a device, or influence the functions of a device will fall into the same classification as that device itself.

However, the TGA's guidance about in vitro diagnostic medical devices (published online on 19 September 2013) clarifies that medical software will be a distinct medical device if:

  • it is software that is provided separately to a medical device (such as hardware) but which is intended to operate, or influence the operation of, the hardware; or
  • it is intended to be used to provide diagnostic or therapeutic information but it is not intended to drive or influence medical hardware (that is, standalone software).

This means that medical software available for use by consumers through smart phones, tablets or computers are likely to be distinct medical devices if the relevant software is intended to be used for a therapeutic purpose such as diagnosing or treating a disease, injury or disability, or for the purpose of controlling conception.

In contrast, software that is limited to merely collating and presenting medical information would not be a medical device and would not fall within the ambit of the TGA's regulatory mandate.

HOW DOES THE TGA REGULATE MEDICAL SOFTWARE?

The TGA regulates medical software and medical apps in the same way that it regulates other medical devices. In short, the TGA takes a risk-based approach, which involves:

  • classifying the medical software under the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Regulations) on the basis of the risks it poses to users (including consumers and medical practitioners);
  • conformity of the medical software with the Essential Principles set out in Schedule 1 to the Regulations, regardless of its classification; and
  • obtaining a Conformity Assessment certification. This requirement applies to all medical software except those devices classified as Class 1 (the lowest risk classification).

Under the Regulations, a medical device that is intended by its manufacturer to rely on a source of electrical energy for its operation is an "active medical device". This could include software used to run a computer or medical device.

Particular classification rules and Essential Principles must be complied with by manufacturers of active medical devices, such as:

  • Essential Principle 9.2 (the risk of reciprocal interference by the active medical device with other devices must be minimised); and
  • Essential Principle 12 (the active medical device must be designed and produced in a way that ensures its reliability and performance).

Different classifications apply for in vitro diagnostic medical devices.

WHAT DOES THIS MEAN FOR YOU?

Developers of medical software and medical apps intended for therapeutic purposes market must apply to the TGA to have their products included on the Australian Register of Therapeutic Goods (ARTG).

In addition, based on the classification system under the Regulations, in most cases, manufacturers will be required to obtain a Conformity Assessment certificate for the medical software.

A Conformity Assessment is the examination of evidence and procedures to ensure that a medical device and its manufacture comply with applicable Essential Principles and other requirements of the Act.

Legal advice should be sought. A person that manufactures or supplies medical software to the Australian market without the approval of the TGA can be liable for criminal and civil sanctions under the Act.

WATCH THIS SPACE

The TGA is a founding member of the International Medical Device Regulators Forum - a voluntary group of national medical device regulators.

Earlier this year, the Forum established the Standalone Medical Device Software Working Group to develop a uniform approach to the regulation of standalone medical device software (including mobile medical apps).

We think it is likely that the TGA will update its guidance once the working group releases its final recommendations.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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