Australian Register of Therapeutic Goods Certificate
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
for approval to supply
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - General
ultrasound imaging system, battery-powered
ARTG Start date
Medical Device Included Class IIa
General ultrasound imaging system, battery-powered
The ultrasound system is a software-based ultrasound imaging system
and accessories intended for use in Point-of-Care Imaging of Medical
Conditions on the general public. Point-of-Care clinical applications
· Emergency triage exam to look at trauma conditions;
· Procedure guidance to guide needles into the body; and
· The ultrasound system is intended for use in environments where
healthcare is provided by trained medical professionals. The device is
not intended for use in emergency medical service, ambulance, or
· Other targeted diagnostic and measurement applications: fetal, fetal
echo, abdominal, small organ, musculo-skeletal (conventional),
musculo-skeletal (superficial), urology, gynecology, cardiac adult,
cardiac pediatric, peripheral vessel, pediatric, carotid. Includes imaging
to assist in the placement of needles and catheters in vascular or other
anatomical structures and imaging guidance for nerve block procedures.
Clarius Mobile Health Corp
3605 Gilmore Way Suites
350 & 102
Burnaby, British Columbia,
ARTG Standard Conditions
The above Medical Device Included Class IIa has been entered on the Register subject to the
· The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are
as specified in section 41FN of the Therapeutic Goods Act 1989.
· The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989
when kinds of medical devices are included in the Register are as set out in the following paragraphs.
· For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor
must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be
· Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in
the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III
medical device, or Class IIb medical device that is an implantable medical device, the distribution
records shall be retained for a minimum period of 10 years. In the case of records relating to any other
device, the distribution records shall be retained for a minimum period of 5 years.
· The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log
of information of the kind specified in Regulation 5.8.
· It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III
or implantable Class IIb provides three consecutive annual reports to the Head of the Office of Product
Review, Therapeutic Goods Administration following inclusion of the device in the ARTG (as specified
in 5.8 of the regulations). Annual reports are due on 1 October each year. Reports should be for the
period 1 July to 30 June. The first report following the date of inclusion in the ARTG must be for a
period of at least six months but no longer than 18 months. Subsequent reports are to be provided on 1
October for a further 2 years. The annual report must include all complaints and adverse events
received by the manufacturer relating to problems with the use of the device that have been received by
them over the year. For orthopaedic implant prosthesis that have been re-classified from Class IIb to
Class III medical devices, annual report information must be submitted if the device meets either of the
following criteria: I.The device was subject to a TGA application audit based on revision rate when the
device transitioned from Class IIb to Class III; and/or II.No devices were supplied to the Australian
marketplace before 30 June 2012. As per the standard automatic condition, annual reports should be
submitted each year for the first three years of inclusion as a Class III medical device on the ARTG.
· Where a medical device included in the Register, contains a substance which is included in the Fourth
Schedule to the Customs (Prohibited Imports) Regulations or the Eighth Schedule to the Customs
(Prohibited Exports) Regulations the Sponsor shall, at the time of importation or exportation of the
medical device, be in possession of a licence and a permission for importation or exportation of each
consignment of the goods as required by those regulations.
· A sponsor shall ensure that a medical device within their control is stored and transported in
accordance with the instructions and information provided by the manufacturer.
Products Covered by This Entry
1. General ultrasound imaging system, battery-powered
Product Specific Conditions
No specific conditions have been recorded against this entry.
Therapeutic Goods Administration
PO Box 100, Woden ACT 2606 Australia
Phone: 1800 020 653
ARTG Identifier: 285246
ARTG Start Date: 6/02/2017