LS&HC Horizons 2022 - Flipbook - Page 34
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
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Covid-19 and Pandemic Preparedness
Australia's regulator has its eyes on face masks in 2022
Personal protective equipment (PPE) are classified as
medical devices in Australia and include a variety of devices
such as surgical and isolation gowns, surgical suits, gloves
and face masks. PPE have come under increased regulatory
scrutiny amid the Covid-19 pandemic and heightened
demand for such products.
By contrast, face masks which are non-sterile and are not
intended by their manufacturer to be used for the prevention
of the transmission of diseases between people are excluded
from regulation by the TGA under the Therapeutic Goods
(Excluded Goods) Determination 2018.
In addition to the Essential Principles, conformity
assessment and general requirements regarding ongoing
quality and risk management and labelling, face masks and
respirators must demonstrate that they meet standards for
certain performance parameters, including:
Australia's Therapeutic Goods Administration (TGA) is
paying much closer attention to the registration of PPE, in
particular face masks, and sponsors are being faced with
increased inquiries by the TGA, including information and
document requests, in order to substantiate registrations on
the Australian Register of Therapeutic Goods (ARTG).
Post-market Review
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urgical and medical face masks must demonstrate that
they meet appropriate standards for fluid resistance,
bacterial filtration efficiency, and breathability; and
Face masks and the ARTG
Face masks meet the definition of a medical device, and are
regulated by the TGA, when the following claims are made:
• the
face masks are used for the prevention of the
transmission of disease between people; or
• t he face masks are suitable for ‘therapeutic use’, such as in
surgical or clinical settings, for medical use, or use in other
health services.
Face masks meeting the definition of a ‘medical device’
must be included on the ARTG before import and/or supply
in Australia. Compliant registrations on the ARTG are the
responsibility of the sponsor of the face mask.
Multiple companies have been issued with infringement
notices by the TGA for, amongst other things, importing face
masks that were not included on the ARTG, including Target
Australia Pty Ltd which was fined AU$13,320.
The TGA is undertaking a post-market review of face masks
included on the ARTG. The review has resulted in several face
masks being cancelled from the ARTG for non-compliance
with the TGA's Essential Principles, highlighting the need
for sponsors to ensure their products meet the required
evidentiary and testing standards.
Issues identified in the TGA’s review include, amongst other
things, insufficient evidence to support claims and incorrect
labelling. The TGA has also issued product recalls for certain
face masks claiming to meet certain standards (such as 'N95'
or equivalent standards) without appropriate evidence to
justify such claims.
TGA Requirements
All medical devices registered on the ARTG must undergo
conformity assessment procedures and comply with the
TGA's Essential Principles for safety and performance.
As the majority of face masks are categorised as Class I
medical devices, most applications to include a face mask
on the ARTG will be required to provide a manufacturer's
Declaration of Conformity as part of the conformity
assessment procedures.
• R
espirators must demonstrate that they meet
appropriate standards for particulate filtration
efficiency, breathability, fit and head strap strength.
Surgical respirators are also required to demonstrate an
appropriate level of fluid resistance.
Sponsors and manufacturers should maintain documentation
regarding the ongoing conformity of their products with the
requirements, as the TGA may request the provision of this
information within a specified timeframe. Failure to comply
with the information request may result in enforcement
actions, which may include fines, infringement notices, and
further civil and criminal penalties.
Aidacare Pty Ltd was recently issued with two infringement
notices and fined AU$26,640 for failing to respond to
information requests, while Life Biotech Pty Ltd was issued
with eight infringement notices and fined AU$106,560 for
failing to provide information and face mask samples, and for
providing false and misleading information to the TGA.
Mandi Jacobson
Partner, Sydney
