Conformity assessment certification: Supporting data form by r900ws

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									Attachment 1: New certificate 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
        Latest version of the Quality Manual                             Y        N     Enter location.
        (ISO 13485:2003, clause 4.2.2)                                                  (e.g., vol.1, section 3, p.10)
        Note: At minimum, this must include a reference to documented
        procedures.


        Device specifications                                                           Enter location.
                                                                         Y        N     (e.g., vol.1, section 3, p.10)

        A list of critical suppliers and a description of how            Y        N     Enter location.
        purchasing requirements are fulfilled (as per                                   (e.g., vol.1, section 3, p.10)
        section 4 of this form).
        (ISO 13485:2003, clause 7.4.1)

        Overview of manufacturing stages for each device                 Y        N     Enter location.
        (detailing manufacturing steps or service provided and party                    (e.g., vol.1, section 3, p.10)
        responsibility—i.e., named critical supplier or manufacturer’s
        facility)

        List of critical processes and the status of their               Y        N     Enter location.
        validation                                                                      (e.g., vol.1, section 3, p.10)
        (ISO 13485:2003, clause 7.5.2.1)

        Procedure for a post-market feedback system                      Y        N     Enter location.
        (ISO 13485:2003, clause 8.2.1, Regulations for post-market).                    (e.g., vol.1, section 3, p.10)


        Procedure for the issue and implementation of                    Y        N     Enter location.
        advisory notices and notification of adverse events                             (e.g., vol.1, section 3, p.10)
        (ISO 13485, clause 8.5.1, Uniform recall procedure for
        therapeutic goods).

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

        Risk management report                                                          Enter location.
        (ISO 14971:2007, clause 8).                                      Y        N     (e.g., vol.1, section 3, p.10)


        Clinical evidence                                                Y        N     Enter location.
        (EP14, Regulation 3.11, Schedule 3, Part 8).                                    (e.g., vol.1, section 3, p.10)


        Labelling and instructions for use                                              Enter location.
                                                                         Y        N     (e.g., vol.1, section 3, p.10)


        Advertising material                                                            Enter location.
                                                                         Y        N     (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 1           Page 1 of 3
 For Design Examination (Schedule 3, clause 1.6) certificates                                  Applicable Y             N

                                                                                    Supplied   Data location
           Design dossier                                                       Y        N     Enter location.
           (A compilation of Quality Management System design and                              (e.g., vol.1, section 3, p.10)
           development records showing conformity to essential principles
           (Clause 7.3 – ISO 13485: 2003 ). The design dossier will
           include the elements listed above—i.e. essential principles
           checklist, etc.).



 For all devices (excluding IVDs) containing medicinal                                         Applicable Y             N
 substance(s)

 Details                                                                            Supplied   Data location
           of whether the medicinal substance(s) have been                      Y        N     Enter location.
           previously used in therapeutic goods supplied in                                    (e.g., vol.1, section 3, p.10)
           Australia
           (i.e., ARTG entry)

           of whether the Drug Master File(s) have been                         Y        N     Enter location.
           submitted to the TGA                                                                (e.g., vol.1, section 3, p.10)
           (i.e., include a letter from the drug supplier that gives the TGA
           authorisation to use the Drug Master File for the purpose of
           assessing your application)

           of quality and safety data regarding medicinal                       Y        N     Enter location.
           requirements for new chemical entities                                              (e.g., vol.1, section 3, p.10)
           (e.g., chemical and pharmaceutical data, etc.—for further
           guidance, please see ARGMD Part 2
           <http://www.tga.gov.au/industry/devices-argmd.htm>)

           of the TGA GMP clearance for the medicinal-                                         Enter location.
           substance manufacturer(s)                                            Y        N     (e.g., vol.1, section 3, p.10)




 For all devices (excluding IVDs) containing material of                                       Applicable Y             N
 animal, microbial, recombinant origin
 Details of                                                                         Supplied   Data location
           quality system records of the assessment,                            Y        N     Enter location.
           evaluation and control of the subcontractors that                                   (e.g., vol.1, section 3, p.10)
           source the manufacturer with materials of animal
           origin.

           quality system procedures to show that the                           Y        N     Enter location.
           principles laid in Conformity Assessment Standard                                   (e.g., vol.1, section 3, p.10)
           Order No 2 have been put in place in the
           manufacturer’s manufacturing facilities

           evidence to demonstrate that the principles in                       Y        N     Enter location.
           Conformity Assessment Standard Order No 2 are                                       (e.g., vol.1, section 3, p.10)
           applied and are relevant to the suppliers of
           materials of animal origin

           the source of suppliers of materials of animal origin                Y        N     Enter location.
           (i.e., country of origin, and certifications by pertinent national                  (e.g., vol.1, section 3, p.10)
           authorities).



 For all sterile devices (excluding IVDs)                                                      Applicable Y             N

                                                                                    Supplied   Data location
 Sterilisation validation reports                                                              Enter location.
 (including method/process)
                                                                                Y        N     (e.g., vol.1, section 3, p.10)



Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 1                  Page 2 of 3
 For all reusable devices (excluding IVDs)                                            Applicable Y              N

 Evidence of                                                            Supplied       Data location
        cleaning and sterilisation method/process                   Y        N         Enter location.
        instructions                                                                   (e.g., vol.1, section 3, p.10)


        cleaning and sterilisation validation reports                                  Enter location.
                                                                    Y        N         (e.g., vol.1, section 3, p.10)



 For all devices incorporating software                                               Applicable Y              N
 Evidence that the manufacturer has met the applicable
                                                                        Supplied       Data location
 EPs by, for example, demonstrating compliance with:
       IEC 62304—Software lifecycle process (or                     Y        N         Enter location.
       equivalent or better)                                                           (e.g., vol.1, section 3, p.10)




 For electrical and electronic devices                                                Applicable Y              N
 Evidence that the manufacturer has met the applicable
                                                                        Supplied       Data location
 EPs by, for example, demonstrating compliance with:
       IEC 60601-1—Medical electrical equipment – Part                                 Enter location.
       1: General requirements for basic safety and                 Y        N         (e.g., vol.1, section 3, p.10)
       essential performance (or equivalent or better)

        IEC 60601-1-2—Medical electrical equipment –                                   Enter location.
        Part 1-2: General requirements for basic safety and                            (e.g., vol.1, section 3, p.10)
        essential performance – Collateral standard:                Y        N
        Electromagnetic compatibility – Requirements and
        tests (or equivalent or better)


 Regulatory history in Australia and other countries                                  Applicable Y              N
 A concise summary of post-market performance data,
                                                                        Supplied       Data location
 including details of
        adverse events                                                                 Enter location.
                                                                    Y        N         (e.g., vol.1, section 3, p.10)


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


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

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


        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 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)



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




Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 1          Page 3 of 3

								
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