Manufacturer's declaration of conformity - System or procedure by s5kG1aU

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									  MANUFACTURER’S DECLARATION OF CONFORMITY
    AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES)
                  REGULATIONS 2002
         SYSTEM or PROCEDURE PACKS (CONTAINING IVD MEDICAL DEVICES)
This declaration of conformity is made under Clause 7.5 of Schedule 3 of the Australian Therapeutic Goods
(Medical Devices) Regulations 2002.

Manufacturer’s Name:            <Entity responsible for design, production, packaging and labelling>

Business Address:               <Physical location of the legal manufacturer>


Kinds of systems or procedure packs to which the procedures have been applied:

Identifier:                     <e.g. product name or model number of each system or procedure pack
                                OR ‘see attached Schedule’ for multiple products>
Contents of Package:            <Identify each item in each system or procedure pack, including device classifications,
                                manufacturer etc
                                OR ‘see attached Schedule’ for multiple products>
 Classification of               <Device classification of the whole system or procedure pack, equivalent to the highest
 Package:                        classification of any medical device in the package, e.g. Class 2 IVD, Class 3 IVD , OR
                                 ‘see attached Schedule’ for multiple products>
 GMDN Code & Term:               <(For Class 4 IVD system or procedure pack) GMDN Preferred term name and code;
                                 OR (For Class 1, 2, or 3 IVD system or procedure pack) GMDN Collective term name
                                 and code; OR ‘see attached Schedule’ for individual multiple products>
Medicines:                      <ARTG Registration or Listing number for each medicine in the package
<if applicable>                 OR ‘see attached Schedule’ for multiple products>
Other Therapeutic Goods: <ARTG Registration or Listing number for each ‘other therapeutic good’ in the package
<if applicable>                 OR ‘see attached Schedule’ for multiple batches>


The manufacturer of the system(s) or procedure pack(s) has evidence that the relevant conformity
assessment procedures have been applied to each medical device in the package; and that each medical
device in the package complies with the applicable provisions of the essential principles.

Each medical device in the package is intended to be used for its original intended purpose, and each
medicine or other therapeutic good in the package is intended to be used within the approved indications for
use specified by the manufacturers of those items.

The mutual compatibility of each medical device, medicine or other therapeutic goods, and any other goods,
in the package has been verified in accordance with any instructions for use provided by the manufacturer of
each item or the approved indications for use of each item. The system(s) or procedure pack(s) have been
manufactured in accordance with those instructions or indications.

The information supplied with the system(s) or procedure pack(s) for use of the system(s) or procedure
pack(s) includes instructions for use provided by the manufacturer of each item in the package.

The process of manufacturing the system(s) or procedure pack(s), and the verification and packaging of the
system(s) or procedure pack(s), has been subjected to a documented method of internal control and
inspection that ensures the safety, quality, performance and effectiveness of each item in the package.

<For systems or procedure packs supplied in a sterile state:>
The production quality assurance procedures (other than clause 4.7) have been applied to the sterile
system(s) or procedure pack(s) in accordance with the manufacturer’s instructions for use, or the approved
indications for use, of each item in the package. The following certification demonstrates compliance with
the quality assurance procedure in relation to the sterilisation of the system(s) or procedure pack(s):
<Assessment Body, Assessment Route and Certificate Number(s):
            TGA issued: Conformity Assessment Certificate(s) – Full Quality Assurance or Production Quality
                        Assurance Procedures OR
            Overseas certification:
                          European In Vitro Diagnostic Medical Devices Directive Annex IV Certificate(s) OR
                          European Medical Devices Directive Annex VII Certificate(s)
            OR ‘see attached Schedule’ for multiple certificates >



Signed by Authorised Person:




Name and Position of Authorised Person                                        Date

								
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