On 13 September 2013, the Therapeutic Goods Association
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
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.
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
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
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
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
Essential Principle 9.2 (the risk of reciprocal interference by
the active medical device with other devices must be minimised);
Essential Principle 12 (the active medical device must be
designed and produced in a way that ensures its reliability and
Different classifications apply for in vitro diagnostic medical
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
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
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
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
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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