manuf-forms-conformity-assessment-certificates-p21

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					Attachment 3: Recertification checklist


                  Note: Copy this section for each kind of medical device as defined by the Therapeutic
                  Goods Act 1989, Section 41BE.

                  An additional copy of the supporting data in electronic format (in Word or PDF format) may
                  assist the TGA with the assessment.


 Quality system documentation                                              Supplied    Data location
        Essential principles checklist supplied                        Y        N      Enter location.
        <http://www.tga.gov.au/industry/devices-forms-essential-                       (e.g., vol.1, section 3, p.10)
        principles-checklist.htm >
        Note: Please include a separate Essential Requirements
        checklist (as per the MDD) if applying for EC Certification.

        Review of risk management file for currency and                Y        N      Enter location.
        relevance, including current copy of risk                                      (e.g., vol.1, section 3, p.10)
        management report
        (as per clause 8 of ISO 14971)

        Details of all changes that have occurred since                Y        N      Enter location.
        certification                                                                  (e.g., vol.1, section 3, p.10)
        (incl. to quality manual, suppliers, production processes)



 For all devices (excluding IVDs) containing medicinal                                Applicable Y              N
 substance(s)
                                                                           Supplied    Data location
        Details of all changes that have occurred since                Y        N      Enter location.
        certification                                                                  (e.g., vol.1, section 3, p.10)




 For all devices (excluding IVDs) containing material of                              Applicable Y              N
 animal, microbial, recombinant origin
                                                                           Supplied    Data location
        Details of all changes that have occurred since                Y        N      Enter location.
        certification                                                                  (e.g., vol.1, section 3, p.10)




 For all sterile devices (excluding IVDs)                                             Applicable Y              N

                                                                           Supplied    Data location
        Details of all changes that have occurred since                Y        N      Enter location.
        certification                                                                  (e.g., vol.1, section 3, p.10)




 For each device                                                           Supplied    Data location
        Concise summary of all new products since                                      Enter location.
        certification                                                  Y        N      (e.g., vol.1, section 3, p.10)

        Concise summary of all design and production                   Y        N      Enter location.
        changes to each device since                                                   (e.g., vol.1, section 3, p.10)
        certification

        Detailed description of any safety related design or           Y        N      Enter location.
        production changes                                                             (e.g., vol.1, section 3, p.10)
        (e.g., in response to adverse event or recall)



Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 3          Page 1 of 3
        Details of any changes to the intended purpose of             Y        N       Enter location.
        any device                                                                     (e.g., vol.1, section 3, p.10)

        Summary of any changes to product labelling and               Y        N       Enter location.
        instructions for use since certification                                       (e.g., vol.1, section 3, p.10)


        List of all devices to not be recertified                     Y        N       Enter location.
                                                                                       (e.g., vol.1, section 3, p.10)




 For each device, a concise summary of post-market
                                                                          Supplied     Data location
 performance data including
        adverse events (Australia and other countries)                                 Enter location.
                                                                      Y        N       (e.g., vol.1, section 3, p.10)


        recalls and alerts (Australia and other countries)                             Enter location.
                                                                      Y        N       (e.g., vol.1, section 3, p.10)


        review of new clinical literature since certification                          Enter location.
                                                                      Y        N       (e.g., vol.1, section 3, p.10)

        review of significance of new safety and                                       Enter location.
        performance standards since certification                     Y        N       (e.g., vol.1, section 3, p.10)


        summary of any new clinical trial data                                         Enter location.
                                                                      Y        N       (e.g., vol.1, section 3, p.10)

        summary of any other clinical data                                             Enter location.
                                                                      Y        N       (e.g., vol.1, section 3, p.10)
        (e.g., customer surveys)


        approvals in other regulatory jurisdictions                                    Enter location.
                                                                      Y        N       (e.g., vol.1, section 3, p.10)
 Has any device in this application been rejected for approval, or the
 application been withdrawn from any other regulatory authority or body?               Y        N

                                            If yes, provide location of the details    Enter location.
                                                                                       (e.g., vol.1, section 3, p.10)

 Has any device in this application been withdrawn from any market around
 the world?                                                                            Y        N

                                            If yes, provide location of the details    Enter location.
                                                                                       (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 3          Page 2 of 3
 Any other substantial change since certification not mentioned above                                   Applicable Y             N
        Description of change relating to manufacturer, supplier or Quality
        Management System (QMS)                                                                         Data location

        Enter description of each change.                                                               Enter location.
        (e.g., if the change affects the manufacturer details, the manufacturer facilities, the         (e.g., vol.1, section 3, p.10)
        suppliers or subcontractors, or the quality management system)



        Description of change relating to the scope of a Schedule 3, Part 1, 4
        or 5 certificate

        Enter description of each change.                                                               Enter location.
        (e.g., if the intention is to extend the scope of a Schedule 3, Part 1, 4 or 5 certificate to   (e.g., vol.1, section 3, p.10)
        add new GMDN codes, or for the introduction of substantial changes to products under
        a GMDN category)



        Description of change relating to the design, material, product or
        indications

        Enter description of each change.                                                               Enter location.
        (e.g., if the change affects the design, indications, etc. of a UPI (unique product)            (e.g., vol.1, section 3, p.10)
        covered by a Schedule 3, Clause 1.6 or a Schedule 3, Part 2 certificate but it does not
        result in a new UPI)



        Details of previous correspondence with the TGA regarding the                                   Enter location.
        application                                                                                     (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 3                           Page 3 of 3

				
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