2021 LS&HC Horizons - Flipbook - Page 57
Life Sciences and Health Care Horizons 2021
57
Australia: Regulatory update on software based medical devices
Following public consultation in early 2019,
the Australian government have implemented
changes to the regulation of software-based
medical devices (SaMDs).
• specifying or recommending a treatment;
and/or
SaMDs are primarily classified as Class I (low
risk) devices as the current classification rules
only consider the possible harm caused by a
physical interaction of a medical device and a
human. SaMDs do not have this direct physical
interaction; rather, the risks posed by software
often relate to incorrect calculation or incorrect
diagnosis, which arguably cause greater harm to
a person. For this reason, the Therapeutic Goods
Administration (TGA) has proposed reforms to
better address the classification of SaMDs in line
with international best practices according to
the factors identified by the International
Medical Device Regulators Forum. These
reforms are set out in the Therapeutic Goods
Legislation Amendment (2019 Measures No.1)
Regulations 2019.
Further, the TGA has sought to clarify the
types of software products that will not be
regulated as a therapeutic good in Australia.
The Therapeutic Goods (Excluded Goods)
Amendment (Software-based Products)
Determination 2021 (2021 Determination)
seeks to expand the list of excluded therapeutic
goods under the Therapeutic Goods (Excluded
Goods) Determination 2018. Generally speaking,
whether the 2021 Determination applies will
largely depend on the manufacturer’s intended
use and whether the software is intended to be
used in clinical practice.
Importantly, the new classification rules for
SaMDs will result in higher risk products being
reclassified at a higher level, particularly SaMDs
intended for:
• diagnosing and screening for a disease or
condition;
• monitoring the state or progression of a
disease, condition, etc;
• providing therapy (via provision of
information).
The above reforms come into effect on 25
February 2021 for new applications for inclusion
in the Australian Register of Therapeutic Goods
(Register). Transitional arrangements will apply
for existing medical devices on the Register.
Mandi Jacobson
Partner, Sydney
mandi.jacobson@hoganlovells.com
