Australian Register of Therapeutic Goods Certificate
Fisher & Paykel Healthcare Pty Ltd
for approval to supply
Fisher & Paykel Healthcare Pty Ltd - High-flow heated humidifier
177298 Class IIa
ARTG Start date
Medical Device Included Class IIa
High-flow heated humidifier
A humidifier for the treatment of patients spontaneously breathing, who
would benefit from receiving high-flow, warmed and humidified
respiratory gases. This includes patients who have had upper airways
Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki, Auckland,
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 Devices,
Blood and Tissues, 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 received by the
manufacturer relating to problems with the use of the device that have been received by them over the
· 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. High-flow heated humidifier
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: 177298
ARTG Start Date: 5/11/2010