Australian Register of Therapeutic Goods Certificate
Issued toEmergo Asia Pacific Pty Ltd T/a Emergo Australia
for approval to supply

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Respiratory
Gating System - Accelerator system synchronizer
ARTG Identifier

233696ARTG Start date

12/02/2015

Product Category

Medical Device Included Class IIb

GMDN

47928

GMDN TermAccelerator system synchronizer

Intended Purpose

The device is intended to sense respiratory movement of the bodysurface of a patient with a respiratory sensor and acquire, display andstore the respiratory information that consists of respiratory waveformand respiratory phase. The device generates the respiratory waveform
signal and the Gate signal that synchronizes with the respiratory
information and outputs them to the external device connected for
imaging diagnosis or radiation therapy. When an organ with respiratory
movement is targeted by the external device synchronizing its irradiation
with the respiratory information (respiratory-gated irradiation), improved
accuracy of diagnostic image or radiation therapy can be attained.

Manufacturer Details

Address

Certificate number(s)Anzai Medical Co Ltd

3-9-15 Nishi-Shinagawa
Shinagawa-ku
Tokyo, ,Japan

DV-2014-MC-18269-1

ARTG Standard Conditions
The above Medical Device Included Class IIb has been entered on the Register subject to thefollowing conditions:· The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register areas 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 beidentified.,· 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 otherdevice, 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 logof 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 ProductReview, Therapeutic Goods Administration following inclusion of the device in the ARTG (as specifiedin 5.8 of the regulations). Annual reports are due on 1 October each year. Reports should be for theperiod 1 July to 30 June. The first report following the date of inclusion in the ARTG must be for aperiod of at least six months but no longer than 18 months. Subsequent reports are to be provided on 1October 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 bythem 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 thefollowing criteria: I.The device was subject to a TGA application audit based on revision rate when thedevice transitioned from Class IIb to Class III; and/or II.No devices were supplied to the Australianmarketplace before 30 June 2012. As per the standard automatic condition, annual reports should besubmitted 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 themedical device, be in possession of a licence and a permission for importation or exportation of eachconsignment of the goods as required by those regulations.,· A sponsor shall ensure that a medical device within their control is stored and transported inaccordance with the instructions and information provided by the manufacturer.

Products Covered by This Entry
1. Respiratory Gating System - Accelerator system synchronizer

Product Specific Conditions· *The inclusion of medical devices under this ARTG entry is only limited to two devices of the kind.
These devices of the kind are medical devices identified by the manufacturer as Respiratory Gating
System (AZ-733V, AZ-733VI) for imaging diagnosis radiation therapy.,*Other devices of the kind mustnot be included and/or supplied under this ARTG entry until and unless an application to vary the entry
is submitted and approved by the TGA.,Note: These conditions do not limit any standard conditions andconditions applying automatically under the Therapeutic Goods Act 1989. In particular, any information
required to be collected and provided by the sponsor under paragraph 41FN(3) of the Act (reportableadverse events) must be provided in accordance with Division 5.2 of Therapeutic Goods (MedicalDevices) Regulations 2002.

Therapeutic Goods Administration
PO Box 100, Woden ACT 2606 Australia
Phone: 1800 020 653
Email: info@tga.gov.au

ARTG Identifier: 233696
ARTG Start Date: 12/02/2015