manuf-forms-conformity-assessment-certificates by panniuniu

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									                                                                         Submission ID
                                                                         Enter Submission ID
                                                                         (Available in eBusiness application on payment of
                                                                         application fee.)


Conformity assessment certification
Supporting data form                                                               Date DD/MM/YYYY

  For manufacturers applying for one or more of the following:
       a conformity assessment certificate
       an EC certificate under the MRA
       a QMS certificate under the TGA – Health Canada MoU

  Applications may be made for new certificates, for changes relating to existing certifications, and for
  recertification of existing certificates.


                  An electronic e-Business application using the ‘Application for a Conformity Assessment
                  Certificate’ form must be made (and application fee paid) prior to submitting this
                  supporting data form and associated data. A Submission ID will be generated once the
                  application fee has been paid. The TGA will then make a request for additional
                  information and data, in conjunction with this form. Any data submitted to the TGA before
                  a request is made will be returned to the applicant.

                  Applicants should refer to the Australian Regulatory Guidelines for Medical Devices
                  <http://www.tga.gov.au/industry/devices-argmd.htm>.

                  IVD device applicants should refer to <http://www.tga.gov.au/industry/ivd-guidance.htm>.




1 General details
1.1 Applicant details

Applicant (Client in eBS)          Enter applicant’s business or commercial name.

                                   Enter physical address.                    Enter postal address.
Address




Contact person                     Enter contact person’s title, first name, surname, and position.


Telephone number                   Enter telephone number.

Mobile number                      Enter mobile number.

Email address                      Enter email address.

TGA client ID                      Enter TGA client ID.



PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 Fax: 02 6232 8605 Email: info@tga.gov.au www.tga.gov.au
Template reference: R11/292971
2 Conformity assessment certification
2.1 Application scope
 This is an application for:

           a new conformity assessment certificate(s)

                Choose a Conformity Assessment Procedure.
                Choose a Conformity Assessment Procedure.

                 Please complete Attachment 1: New certificate checklist

           a change relating to an existing certificate(s)    List certificate number(s).



                 Short description of the change

                 Enter short description of the change.




                  Please complete Attachment 2: Substantial change checklist


           recertification of an existing conformity assessment certificate(s)

                for certificate number(s)                      List certificate number(s).



                 Please complete Attachment 3: Recertification checklist

And for certificate types:

           TGA conformity assessment certificate
           MRA EC certificate issued under the Medical Devices Directive (93/42/EEC)
            (Australian and New Zealand manufacturers only)
           QMS certificate issued under the TGA – Health Canada MoU
            (Australian and New Zealand manufacturers only)




2.2 Details for assessment fee invoicing

                 Please refer to the scheduled fees. <http://www.tga.gov.au/about/fees.htm >

                 Applicants may make a request for a reduction in fees in some circumstances.



Name and position                    Enter title, first name, surname, and position for fee invoicing.

Email address                        Enter email address for fee invoicing.

Reduction request                    Enter location of the request for a reduction of assessment fees.
                                     (if applicable)

Telephone number                     Enter telephone number for fee invoicing.


Conformity assessment certification—Supporting data form (Version 2011-08-25)                        Page 2 of 14
3 Manufacturer details
3.1 Manufacturer’s details
 Name                              Enter manufacturer’s name.

                                   Enter manufacturer’s trading name.
 Trading name
                                   (Leave blank if not applicable.)

                                   Enter Australian Business Number (ABN).
 Australian Business Number
                                   (Australian manufacturers only)

 Head office address               Enter physical office address.          Enter postal address.




                                   Enter website address.
 Website address
                                   (e.g., ‘http://www.website.com’)

                                   Enter TGA Client ID.
 TGA Client ID
                                   (If available)

 Contact person                    Enter contact person’s title, first name, surname, and position.


 Email address                     Enter email address for the contact person.


 Telephone number                  Enter telephone number for the contact person.



3.2 European representative (for MRA EC certificates only)

Name                              Enter European representative name.

Contact person                    Enter contact person’s title, first name, surname, and position.

Head office address               Enter physical address.                  Enter postal address.




Telephone number                  Enter telephone number.

Mobile number                     Enter mobile number.

Email address                     Enter email address.




Conformity assessment certification—Supporting data form (Version 2011-08-25)                        Page 3 of 14
3.3 Manufacturer facility details
Note: If the manufacturer has more than one facility, please copy this section 3.3 for each facility.

                                  As per manufacturer’s details in Section 3.1 of this form

Address and contact

Facility name                        Enter facility name.

Facility address                     Enter facility physical address.




Contact person                       Enter contact person’s title, first name, surname, and position.

Telephone number                     Enter telephone number.

Email address                        Enter email address.



Facility scope                       Enter stages performed at this site.
                                     (e.g., design, production, packaging, labelling, final release, warehousing and dispatch)




3.4 Current certification details
TGA certificates held by the manufacturer

Certificate Number        Scope of Certificate                                                                Date of last audit



Enter number.             Enter scope of certificate.                                                            DD/MM/YYYY


Enter number.             Enter scope of certificate.                                                            DD/MM/YYYY


Enter number.             Enter scope of certificate.                                                            DD/MM/YYYY


Enter number.             Enter scope of certificate.                                                            DD/MM/YYYY


Enter number.             Enter scope of certificate.                                                            DD/MM/YYYY


Enter number.             Enter scope of certificate.                                                            DD/MM/YYYY




Conformity assessment certification—Supporting data form (Version 2011-08-25)                                    Page 4 of 14
EC (European) quality management system certificates held by the manufacturer

Applicable                Y        N

Certificate number        Enter number.                    Notified body   Enter issuing body.

Commencement date         DD/MM/YYYY                       Expiry date     DD/MM/YYYY

Certificate type          Enter certificate type.
                          (e.g., Annex IV)

Scope                     Enter scope of certificate.




Conditions or             Enter conditions or limitations.
limitations




Products                  Enter products.




Certificate location      Enter location of the copy of the certificate in the supporting data.
                          (e.g., vol.1, section 3, p.10)

Date of last audit        DD/MM/YYYY

Location audit report     Enter location of last audit report in the supporting data.
                          (e.g., vol.1, section 3, p.10)



Conformity assessment certification—Supporting data form (Version 2011-08-25)                     Page 5 of 14
EC (European) design/type examination certificates held by the manufacturer

Applicable                Y        N

Certificate number        Enter number.                    Notified body   Enter issuing body.

Commencement date         DD/MM/YYYY                       Expiry date     DD/MM/YYYY

Certificate type          Enter certificate type.
                          (e.g., Annex II.4)

Scope                     Enter scope of certificate.




Conditions or             Enter conditions or limitations.
limitations




Products                  Enter products.




Certificate location      Enter location of the copy of the certificate in the supporting data.
                          (e.g., vol.1, section 3, p.10)

Location report           Enter location of notified body report in the supporting data.
(if available)            (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)                     Page 6 of 14
ISO 13485 certificates held by the manufacturer
(IVD medical devices only)

Applicable                Y        N

Certificate number        Enter number.                    Issuing body   Enter issuing body.

Commencement date         DD/MM/YYYY                       Expiry date    DD/MM/YYYY

Certificate type          Enter certificate type.
                          (e.g., accredited ISO 13485)

Scope                     Enter scope of certificate.




Conditions or             Enter conditions or limitations.
limitations




Certificate location      Enter location of the copy of the certificate in the supporting data.
                          (e.g., vol.1, section 3, p.10)

Date of last audit        Click here to enter a date.

Location audit report     Enter location of last audit report in the supporting data.
                          (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)                     Page 7 of 14
CMDCAS (Canadian) ISO13485 certificates held by the manufacturer

Applicable                 Y        N

Certificate number         Enter number.                    Registrar     Enter CMDCAS Registrar.

Commencement date          DD/MM/YYYY                       Expiry date   DD/MM/YYYY

Certificate type           Enter certificate type.

Scope                      Enter scope of certificate.




Conditions / limitations   Enter conditions or limitations.




Products                   Enter products.




Certificate location       Enter location of the copy of the certificate in the supporting data.
                           (e.g., vol.1, section 3, p.10)

Date of last audit         DD/MM/YYYY

Location audit report      Enter location of last audit report in the supporting data.
                           (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)                      Page 8 of 14
Health Canada Class 3 and 4 product licences held by the manufacturer

Applicable                Y        N

Licence number            Enter number.

Commencement date         DD/MM/YYYY                       Expiry date   DD/MM/YYYY

Licence type              Enter licence type.

Scope                     Enter scope of licence.




Conditions/limitations    Enter conditions or limitations.




Products                  Enter products.




Licence location          Enter location of the copy of the licence in the supporting data.
                          (e.g., vol.1, section 3, p.10)

Location of report        Enter location of Health Canada report.
(if available)            (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)                 Page 9 of 14
4 Critical supplier’s details

                  A critical supplier provides materials or services that are fundamental in ensuring the
                  safety, quality, or efficacy of the device. This should be determined by the manufacturer’s
                  risk assessment.
                  The following are examples of critical suppliers:
                     Suppliers of raw materials for medicinal substances, active ingredients, and suppliers
                      of material of animal, microbial or recombinant origin.
                     Suppliers of sterilisation services
                     Design activities for manufacturers holding or applying for a full quality assurance
                      certificate
                     Suppliers that carry out all stages of production and supply

                  The critical suppliers will be listed on the certificate(s).


                  Copy this section for each critical supplier.



Supplier’s name               Enter supplier’s name.

Supplier’s address            Enter supplier’s address.




TGA Client ID                 Enter supplier’s TGA client ID.
                              (if available)

Scope                         Enter stages performed at this site or services provided, and for which device(s).




Conformity assessment certification—Supporting data form (Version 2011-08-25)                     Page 10 of 14
5 Device details (non-IVD devices only)
Copy this section for each kind of medical device.


Device name                Enter device name.

GMDN code                  Enter GMDN code.                  Enter GMDN term.
                           (e.g., 34179)                     (e.g., stent, vascular, coronary artery)

Unique Product             Enter list of Unique Product Identifier’s (UPIs).
Identifier (UPI)
(For Class III and class
AIMD only)




Variants                   Enter list of variants.
(For Class III and class   (e.g., diameter and lengths ranges, etc.)
AIMD only)




Australian                 Choose a class.                   Applicable rule (Australia)                Enter classification rule.
classification                                                                                          (e.g., 3.4(4)(a))

EU classification          Choose a class.                   Applicable MDD rule                        Enter classification rule.
(For MRA EC                                                  (For MRA EC applications)                  (e.g., rule 5)
certification
applications)

Supplied sterile                                   Y        N


Single-use                                         Y        N


Incorporates a measuring function                  Y        N


Re-usable                                          Y        N


Active medical device                              Y        N


          Incorporating software                   Y        N




Conformity assessment certification—Supporting data form (Version 2011-08-25)                                               Page 11 of 14
Intended purpose                  Enter the manufacturer’s intended purpose for the device.
                                  For example:
                                  Used to display and/or record real-time arterial blood pressure, intracranial (inside the skull)
                                  pressure, cerebral perfusion (blood flow in the brain) pressure, temperature, respiratory
                                  (breathing) rate, electrical activity of the heart, pulsatile (pulsing) heart rate, and/or oxygen
                                  saturation (percentage of oxygen in the blood).

                                  The device is used by a clinician for the monitoring of a patient and for the diagnosis of
                                  illness or disease.




Description of the device         Enter short description of the device.
                                  For example:
                                  The device is a diagnostic device intended to measure physiological parameters during
                                  walking. The device detects and records body signals via attached sensors.

                                  The following components are part of the device:
                                       -    Software
                                       -    Microcontroller
                                       -    Battery
                                       -    Hardware interface (LCD screen and buttons)

                                  The device detects and records information on a portable hard drive. With the help of the
                                  associated PC software, the recorded information can be read and analysed by the clinician.
                                  Clinical parameters are detected via vibrations measured by the device.
                                  The devices are supplied non-sterile.




For devices incorporating ancillary medicinal substances, material of animal, microbial or
recombinant origin

                                                                                                  Data location
Device incorporates a medicinal substance that has an                                             Enter Location.
action that is ancillary to the device                                Y            N              (e.g., vol.1, section 3, p.10)

Device incorporates an extract from human blood or                                                Enter Location.
plasma that has an action that is ancillary to the device             Y            N              (e.g., vol.1, section 3, p.10)

Device incorporates material or substances of animal                                              Enter Location.
origin or, was manufactured using materials of animal                 Y            N              (e.g., vol.1, section 3, p.10)
origin
Device incorporates or was manufactured using                                                     Enter Location.
material or substances of microbial origin                            Y            N              (e.g., vol.1, section 3, p.10)

Device incorporates material or substances produced                                               Enter Location.
using recombinant technology                                          Y            N              (e.g., vol.1, section 3, p.10)


Conformity assessment certification—Supporting data form (Version 2011-08-25)                                       Page 12 of 14
6 IVD device details
Copy this section for each kind of IVD medical device.


Device name            Enter device name.

GMDN code              Enter GMDN code.             Enter GMDN term.
                       (e.g., 34179)

Unique Product         Enter list of Unique Product Identifier’s (UPIs).
Identifier (UPI)
(For Class 4 IVDs)




Variants               Enter list of variants.
(For Class 4 IVDs—
Immunohaematology
reagents only)




Australian             Choose a class.              Applicable rule             Enter classification rule.
classification




Conformity assessment certification—Supporting data form (Version 2011-08-25)                   Page 13 of 14
Intended purpose                  Enter the manufacturer’s intended purpose for the device.




Description of the device         Enter short description of the device.




Conformity assessment certification—Supporting data form (Version 2011-08-25)                 Page 14 of 14
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
Attachment 2: Substantial change 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.


 Description of substantial change provided                                                             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
        intended purpose

        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 2                           Page 1 of 3
                  Please complete the checklist below as applicable for substantial changes.




                                                                          Substantial
 Quality system documentation                                                           Data location
                                                                           change
        Change to 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.


        Change to product requirements (specifications) for              Y       N      Enter location.
                                                                                        (e.g., vol.1, section 3, p.10)
        the product

        Change to manufacturing stages                                   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)

        Change to 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)

        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                                            (e.g., vol.1, section 3, p.10)
        risk management report
        (ISO 14971:2007, clause 8)


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


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



 For all devices (excluding IVDs) containing medicinal substance(s)                     Applicable Y             N
                                                                          Substantial
 Details of                                                                             Data location
                                                                           change
        change to suppliers                                              Y      N       Enter location.
        (including which suppliers provide which services or materials                  (e.g., vol.1, section 3, p.10)
        for which products)


        change to production process                                                    Enter location.
                                                                         Y      N       (e.g., vol.1, section 3, p.10)

        change to production facilities                                  Y      N       Enter location.
        (e.g., new equipment)                                                           (e.g., vol.1, section 3, p.10)


        change to drug master file                                                      Enter location.
                                                                         Y      N       (e.g., vol.1, section 3, p.10)


        up-to-date GMP clearance status of supplier                                     Enter location.
                                                                         Y      N       (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 2           Page 2 of 3
 For all devices (excluding IVDs) containing material of animal,                         Applicable Y            N
 microbial, recombinant origin
                                                              Substantial
        Details of                                                                      Data location
                                                                 change
        change to subcontractors that provide materials of   Y       N                  Enter location.
        animal origin                                                                   (e.g., vol.1, section 3, p.10)


        change to suppliers                                              Y      N       Enter location.
        (including which suppliers provide which services or materials                  (e.g., vol.1, section 3, p.10)
        for which products)


        significant change to production process                                        Enter location.
                                                                         Y      N       (e.g., vol.1, section 3, p.10)

        change to production facilities                                  Y      N       Enter location.
        ( e.g., new equipment)                                                          (e.g., vol.1, section 3, p.10)


        change to material species origin                                               Enter location.
                                                                         Y      N       (e.g., vol.1, section 3, p.10)



 For all sterile devices (excluding IVDs)                                               Applicable Y             N
                                                                          Substantial
 Details of                                                                             Data location
                                                                           change
        change to suppliers                                              Y      N       Enter location.
        (including which suppliers provide which services for which                     (e.g., vol.1, section 3, p.10)
        products)


        change to sterilisation method/process                                          Enter location.
                                                                         Y      N       (e.g., vol.1, section 3, p.10)

        change to sterile production facilities                          Y      N       Enter location.
        (e.g., new clean room, new equipment)                                           (e.g., vol.1, section 3, p.10)




                                                                          Substantial
 For each device                                                                        Data location
                                                                           change
        Concise summary of all design and production                     Y      N       Enter location.
        changes                                                                         (e.g., vol.1, section 3, p.10)

        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)

        Details of any changes to the intended purpose of                Y      N       Enter location.
        the device                                                                      (e.g., vol.1, section 3, p.10)




Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 2           Page 3 of 3
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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