Australian Register of Therapeutic Goods Certificate
Issued to
Microgenics Diagnostics Pty Ltd
for approval to supply
Instrument/analyser IVDs
ARTG Identifier
190292 Class 1
ARTG Start date
7/10/2011
Product Category:
Medical Device Included - IVD Class 1
GMDN
CT943
GMDN Term
Instrument/analyser IVDs
Intended Purpose
Instruments / Analysers used as an in vitro diagnostic medical device
(IVD) for the purposes of processing, examining and/or providing
information about a clinical specimen.
Manufacturer Details
Address
Certificate number(s)
Brahms GmbH
Neuendorfstrasse 25
Hennigsdorf, , 16761
Germany
ARTG Standard Conditions
The above Medical Device Included - IVD Class 1 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.
· 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.
· 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.
· It is a condition of inclusion in the ARTG that the sponsor of a medical device that is a Class 4 IVD
provides three consecutive annual reports to the Head of the Office of Devices Authorisation,
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 year.
· Goods which would require an application audit under Regulation 5.3 if subject to a separate
application for entry in the Register cannot be included under this ARTG entry until a request to vary the
entry has been submitted and approved by the TGA.
Products covered by this Entry
1. Instrument/analyser IVDs
