ARTG Certificate CSZ Products Feb 2007

Australian Register of Therapeutic Goods Certificate Issued to

Paragon Healthcare Pty Ltd for approval to supply

Paragon Healthcare Pty Ltd - Hyperthermia system, heated fluid ARTG Identifier

135609

ARTG Start date

27/02/2007

Product Category

Medical Device Included Class IIb

GMDN

40784

GMDN Term

Hyperthermia system, heated fluid

Intended Purpose

A device used to maintain, raise or lower a patient's body temperature through conductive heat transfer whereby heated or cooled water is pumped from the unit to a blanket.

Manufacturer Details

Address

Cincinnati Sub Zero Products Inc

12011 Mosteller Road Cincinnati, OH, 45241-1528 United States Of America

Certificate number(s)

ARTG Standard Conditions The above Medical Device Included Class IIb has been entered on the Register subject to the following conditions: · 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 identified., · 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., · 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., · 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