Conformity assessment certification

TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <http://www.tga.gov.au/about/tga-information-to.htm>. Conformity assessment certification Supporting data form Submission ID*: Date (YYYY-MM-DD): For manufacturers applying for one or more of the following: a conformity assessment certificate (CA) a CE certificate under the Australian European Mutual Recognition Agreement (MRA) 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. Applicants should refer to the Australian Regulatory Guidelines for Medical Devices <http://www.tga.gov.au/industry/devices-argmd.htm> and application instructions <http://www.tga.gov.au/industry/manuf-forms-conformity-assessment-certificates.htm>. IVD device applicants should refer to <http://www.tga.gov.au/industry/ivd-guidance.htm>. Please forward a completed copy of this form, together with all relevant supporting (as one electronic copy), to: Postal address Devices Conformity Assessment Section Office of Devices Authorisation Therapeutic Goods Administration PO Box 100 Woden ACT 2606 or Courier delivery Devices Conformity Assessment Section Office of Devices Authorisation Therapeutic Goods Administration 136 Narrabundah Lane Symonston ACT 2609 Please note: Fields marked with a * are mandatory. Failure to complete all fields may result in the lapsing of your application under section 41EG of the Act. PO Box 100 Woden ACT 2606 ABN 40 939 406 804 Phone: 1800 020 653 Fax: 02 6203 1605 Email: info@tga.gov.au http://www.tga.gov.au Template reference R11/454431

ISO 13485 certificates Australian manufacturers may apply for a separate ISO13485:2003 certificate from the TGA Office of Manufacturing Quality (OMQ) after a CA certificate has been issued by the Office of Devices Authorisation (ODA).To apply, use the form available on the TGA website: <http://www.tga.gov.au/industry/manuf-forms-certificates-request.htm> Canadian MoU certificates Australian manufacturers may apply for an ISO13485:2003 certificate that incorporates an assessment under the MoU between the TGA and Health Canada s Health Products and Food Branch on QMS certification for medical devices. Manufacturers are to submit an application at the same time as a conformity assessment application or at least 6 weeks prior to their next surveillance inspection. Contact the liaison officer for further information: Medical Devices Audit Team Manager Office of Manufacturing Quality Phone: 1800 446 443 Fax: 02 6232 8426 Email: gmp@tga.gov.au For official use only Page 2 of 38

1. General details 1.1. Applicant details Applicant s business or commercial name (Client in ebs)* Physical address* Postal address* Contact person (full name)* Telephone number* Mobile number Email address* TGA Client ID* 1.2. Details for assessment fee invoicing (contact person) Please refer to the scheduled fees. <http://www.tga.gov.au/about/fees.htm>. Applicants may make a request for an abridged assessment in some circumstances, which may result in reduced assessment fees. Refer to the TGA guideline for reduction of medical device assessment fees for further information: <http://www.tga.gov.au/industry/devices-guidelines-reductionassessment-fees.htm>. Full name and position for fee invoicing* Telephone number* Email address* Location of request for a reduction of assessment fees, if applicable(e.g. vol 1, section 3, pg 10)* For official use only Page 3 of 38

2. Application scope Specify the scope of this application by selecting one or more of the following sections. Follow your application s link to view further instructions: Application for a conformity assessment certificate, new device description on existing certificate or new Unique Product Identifier Go to 2.1 Application for substantial changes to an existing certificate or to the design of existing devices Go to 2.2 Application for recertification of an existing conformity assessment certificate(s) Go to 2.3 Application for MRA CE certificate issued under the Medical Devices Directive (93/42/EEC) (Australian manufacturers only) Go to 2.4 For official use only Page 4 of 38

2.1. Application for a conformity assessment certificate, new device description on existing certificate or new Unique Product Identifier Choose one or more of the following 3 options: A new conformity assessment certificate(s) (Schedule 3, Part 1, 3, 4 or 5) New device description(s) to be added to existing certificates (Schedule 3, Part 1, 3, 4 or 5) New Unique Product Identifier(s) or new device(s) (Schedule 3, Clause 1.6 or Part 2) 2.1.1. Choose one Conformity Assessment Procedure only: Part 1 - Full Quality Assurance (including Clause 1.6) Part 1 - Full Quality Assurance (excluding Clause 1.6) Clause 1.6 only - Examination of Design Part 2 - Type Examination Part 3 - Verification Procedure (non-sterile only) Part 4 - Production Quality Assurance Part 5 - Production Quality Assurance (non-sterile) 2.1.2. Enter a short description of the application: For this type of application, you must complete: Section 1: General details Section 3: Manufacturer s details Section 4: Critical suppliers details Either Section 5: Device details (non-ivd only) or Section 6: Device details (IVD only), depending on your device(s) Attachment 1: New certificate checklist. For official use only Page 5 of 38

2.2. Application for substantial changes to an existing certificate or to the design of existing devices Provide certificate numbers if applicable: A substantial change relating to an existing certificate(s) (Schedule 3, Part 1, 3, 4 or 5). List certificate number(s) are: A substantial change relating to the design of existing device(s) (Schedule 3, Clause 1.6 or Part 2). List certificate number(s) are: 2.2.1. Enter a short description of the change: For this type of application, you must complete: Section 1: General details Attachment 2: Substantial change checklist For official use only Page 6 of 38

2.3. Application for recertification of an existing conformity assessment certificate(s) 2.3.1. For certificate number(s) For this type of application, you must complete: Section 1: General details Section 3: Manufacturer s details Section 4: Critical suppliers details Attachment 3: Recertification checklist For official use only Page 7 of 38

2.4. Application for MRA CE certificate issued under the Medical Devices Directive (93/42/EEC) (Australian manufacturers only) For this type of application, you must complete: Section 1: General details Section 3: Manufacturer s details (including Section 3.2) Section 4: Critical suppliers details (including Section 4.1.1) Section 5: Device details (non-ivd only) The final page of Attachment 1: New certificate checklist For official use only Page 8 of 38

3. Manufacturer s details (for all applications) 3.1. Manufacturer s details Manufacturer s name* Trading name TGA Client ID Head office physical address* Head office postal address* Australian Business Number (ABN) Website address e.g. http://www.website.com Full name and title of contact person* Position of contact person* Telephone number of contact person* Email address of contact person* *TGA CA certificates are issued in electronic format via email. Certificates will not be able to be issued unless this information is provided. 3.2. European representative (for Australian manufacturers applying for MRA CE certificates only) European representative s name Full name and title of contact person Position of contact person For official use only Page 9 of 38

Telephone number of contact person Mobile number of contact person Email address of contact person Head office physical address Head office postal address 3.3. Manufacturer facility (site) details te: If the manufacturer has more than one facility, please provide a copy of Section 3.3 for each additional facility. As per manufacturer s details in Section 3.1 of this form: 3.3.1. Address and contact (if different to details provided in Section 3.1) Facility name Facility physical address Facility scope, i.e. manufacturing stages performed at this site (e.g. design, production, labelling, final release, warehousing and dispatch) Full name and title of contact person Position of contact person Telephone number of contact person Email address of contact person For official use only Page 10 of 38

3.4. Current certification details Applicants should provide information on any relevant certificates held by the manufacturer, as it may assist the TGA in abridging the application. 3.4.1. Current TGA certificates held by the manufacturer QMS CA certificate number e.g. AU Q00123/02 (Schedule 3, Part 1, 4 or 5 of Regs 2002) QMS MRA CE (European) certificate number e.g. MRA Q00100/02 (Annex II, V or VI of MDD 93/42/EEC) QMS MoU Canada certificate number ( MoU Canada certificate, ISO 13485) Design examination certificate number e.g. AU DE00123/02 (Schedule 3, Part 1, clause 1.6 of Regs 2002) MRA CE (European) design examination certificate number e.g. MRA DE00123/02 (TGA Annex II.4 of MDD 93/42/EEC) Type examination certificate number (Schedule 3, Part 2 of Regs 2002) MRA CE (European) Type examination certificate number (TGA Annex III of MDD 93/42/EEC) Other TGA certificate or licence number 3.4.2. EC (European) quality management system certificates held by the manufacturer (Annex II, V or VI of Medical Device Directive European Union) Applicable Certificate number tified body Commencement date Expiry date Certificate type e.g. Annex IV Scope of certificate For official use only Page 11 of 38

Conditions or limitations Products Location of certificate in supplied supporting data (e.g. vol. 1, section 3, p.10) Date of last audit Date of last full audit (initial or recertification) Location of audit report in supplied supporting data (e.g. vol.1, section 3, p 10) For official use only Page 12 of 38

3.4.3. EC (European) design/type examination certificates held by the manufacturer (Annex II section 4 or Annex III of Medical Device Directive European Union) Applicable Certificate number Commencement date tified body Expiry date Certificate type e.g. Annex II.4 Scope of certificate Conditions or limitations Products Location of certificate in supplied supporting data (e.g. vol. 1, section 3, p.10) Location of assessment report in supplied supporting data (if available) (e.g. vol.1, section 3, p 10) For official use only Page 13 of 38

3.4.4. ISO 13485 certificates held by the manufacturer (IVD only) Applicable Certificate number Commencement date Issuing body Expiry date Certificate type e.g. accredited ISO 13485 Scope of certificate Conditions or limitations Location of certificate in supplied supporting data (e.g. vol. 1, section 3, p.10) Date of last audit Date of last full audit (initial or recertification) Location of last full Audit report in supplied supporting data (e.g. vol.1, section 3, p 10) Location of last surveillance Audit report in supplied supporting data (e.g. vol.1, section 3, p 10) For official use only Page 14 of 38

3.4.5. QMS certificate issued under the TGA / Health Canada MoU on QMS Certification for Medical Devices by a Canadian Registrar Applicable Certificate number Commencement date Canadian Registrar Expiry date Certificate type Scope of certificate Conditions or limitations Products Location of certificate in supplied supporting data (e.g. vol. 1, section 3, p.10) Date of last audit Date of last full audit (initial or recertification) Location of last full Audit report in supplied supporting data (e.g. vol.1, section 3, p 10) Location of last surveillance Audit report in supplied supporting data (e.g. vol.1, section 3, p 10) For official use only Page 15 of 38

3.4.6. Health Canada Class 3 and 4 product licences held by the manufacturer Applicable Licence number Commencement date Expiry date Licence type Scope of licence Conditions or limitations on license Products Location of licence in supplied supporting data (e.g. vol. 1, section 3, p.10) Location of assessment report (if available) in supplied supporting data (e.g. vol.1, section 3, p 10) For official use only Page 16 of 38

4. Critical supplier details A critical supplier delivers materials (raw or processed), components (including hardware and software), or services, that may influence the safety and performance of the product. The following is a non-exhaustive list of examples of critical suppliers: suppliers of certain types of raw materials, including; medicinal substances, active ingredients, and material of animal, microbial or recombinant origin. suppliers of sterilisation services. suppliers of design and development activities for manufacturers holding, or applying for, a full quality assurance Conformity Assessment certificate. suppliers that carry out all stages of production and supply on behalf of the manufacturer. The TGA may list some, or all, of the identified critical suppliers on a Conformity Assessment certificate(s). te: In the context of a QMS inspection of medical device manufacturers, a critical supplier is a supplier of a product or service, the failure of which to meet specified requirements could cause unreasonable risk to the patient, clinician, or others; or could cause a significant degradation in performance. The manufacturer should determine the type and extent of controls to be applied to outsourced processes or purchased products from the risk management that is applied throughout product realisation. (See clauses 7.1, 4.1, and 7.4.1 of ISO13485:2003). Copy this section for each critical supplier: Supplier s name Supplier s physical address TGA Client ID (if available) Scope (i.e. stages performed at this site or services provided for which device[s]) For official use only Page 17 of 38

5. Device details (non-ivd devices only) Copy this section for each kind of medical device Device name GMDN code e.g. 34179 GMDN term (e.g. stent, vascular, coronary artery) Unique Product Identifier List of variants e.g. diameter and length ranges (For Class III and class AIMD only) (For Class III and class AIMD only) For further information, refer to the Australian Regulatory Guidelines for Medical Devices <http://www.tga.gov.au/industry/devicesargmd.htm>. For further information, refer to the Australian Regulatory Guidelines for Medical Devices <http://www.tga.gov.au/industry/devicesargmd.htm>. Select the device s Australian classification level Refer to Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2. Class I Class IIa Class IIb Class III AIMD Applicable classification rule (Australia) e.g. 3.4(4)(a) Select the device s EU classification level (For MRA CE certification applications) Refer to COUNCIL DIRECTIVE 93/42/EEC, ANNEX IX, III. CLASSIFICATION. Class I Class IIa Class IIb Class III AIMD Applicable classification rule (EU) e.g. rule 5 (For MRA CE certification applications) Is the device supplied sterile? For official use only Page 18 of 38

Is the device single-use? Does the device incorporate a measuring function? Is the device an Active medical device? Does the device incorporate software? 5.1. For devices incorporating ancillary medicinal substances, material of animal, microbial, or recombinant origin What is 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 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 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 official use only Page 19 of 38

Device incorporates a medicinal substance that has an action that is ancillary to the device Device incorporates an extract from human blood or plasma that has an action that is ancillary to the device Device incorporates material or substances of animal origin or was manufactured using materials of animal origin Device incorporates or was manufactured using material or substances of microbial origin Device incorporates material or substances produced using recombinant technology For official use only Page 20 of 38

6. IVD medical device details Copy this section for each kind of IVD Device name GMDN code e.g. 34179 GMDN term (e.g. stent, vascular, coronary artery) Unique Product Identifier (For Class 4 IVDs) For further information, refer to IVD guidance documents <http:/www.tga.gov.au/industry/ivdguidance.htm>. List of variants Classification (For Class 4 IVDs- Immunohaematology reagents only) For further information, refer to IVD guidance documents <http:/www.tga.gov.au/industry/ivdguidance.htm>. Refer to Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2A or to guidance documents <http://www.tga.gov.au/industry/ivdclassification.htm>. Class 1 Class 2 Class 3 Class 4 Applicable classification rule (Australia) What is the manufacturer s intended purpose for the device? Description of the device For official use only Page 21 of 38

Attachment 1: New certificate checklist You are required to complete this attachment for: New conformity assessment certificate(s) (Schedule 3, Parts 1, 3, 4 or 5 only). New Unique Product Identifier(s)/Devices (Schedule 3, Clause 1.6 (Design examination) or Part 2 (type examination) only). You are required to provide the data location details (i.e. where the document is located within the supplied data package) when a section is checked as Applicable Y. For Design Examination (Schedule 3, clause 1.6) certificates Applicable Information Location of information in supplied supporting Design dossier A compilation of Quality Management System design and development records showing conformity to essential principles. The design dossier should include and records specific to the subject device that results from the implementation of the manufacturer s design and development procedures (ISO 13485: 2003, Clause 7.3) and should also include the elements listed in the sections below where relevant to the type of product. Quality Management System Applicable Y N Manufacturers must be able to demonstrate that a scheduled program of internal audit and management review in accordance with ISO13485:2003-Clauses 8.2.2 and 5.6, has been defined, and undertaken, prior to an audit. These processes must consider whether the manufacturer has implemented and complied with ISO13485:2003 and the regulatory requirements of target markets (e.g., Australia, Canada and the European Union.) If an audit of the manufacturer s QMS is required during this application, the Office of Manufacturing Quality (OMQ) will contact the manufacturer prior to the audit and request relevant QMS for review. For official use only Page 22 of 38

Information Location of information in supplied supporting Overview of manufacturing stages for each device (detailing manufacturing steps, or service provided, and the responsible party-i.e., named critical supplier or manufacturer s facility). Requirements related to the product (ISO13485, Clause 7.2.1) Latest version of the Quality Manual (ISO 13485, clause 4.2.2) te: At minimum, this must include a reference to documented procedures. A description of how purchasing requirements are fulfilled for the suppliers identified at section 4 of this form. (ISO 13485, clause 7.4.1, 7.4.2 and 7.4.3) List of processes where the resulting output cannot be verified by subsequent monitoring or measurement and the status of their validation (ISO 13485, clause 7.5.2.1) For each process validation considered critical to the safety and effectiveness of the device: Protocols/Procedures for the validated process. Process validation report. The procedures for monitoring and controlling the process parameters of a validated process should be fully described. State the frequency of re-validation Procedures for a post-market monitoring system (ISO 13485, clauses 8.2.1; Therapeutic Goods (Medical Devices) Regulations 2002 (Regulations)- Schedule 3, Part 1 1.4(3), Part 4 4.4(3) or Part 5 5.4(3)). Procedure for the issue and implementation of advisory notices and the notification of adverse events (ISO 13485, clauses 7.2.3, 8.5.1; Regulations-Schedule 3, Part 1 1.4(3), Part 4 4.4(3) or Part 5 5.4(3) and regulation 5.7-Uniform Recall Procedure). For official use only Page 23 of 38

Information Location of information in supplied supporting Procedures for a corrective and preventive action system (ISO 13485, clauses 8.5.2, 8.5.3; Regulations-Schedule 3, Part 1 1.4(3), Part 4 4.4(3) or Part 5 5.4(3) and regulation 5.7). Procedures for records control (ISO 13485, clauses 4.2.4; Regulations-Part 8 regulation 8.1) An undertaking (in writing) by the manufacturer to continue to comply with the requirements of the quality management system after assessment.* (Regulations-Schedule 3, Part 1.3(2)(e), Part 4.3(2)(e) or Part 5.3(2)(e)). An undertaking (in writing) by the manufacturer to ensure that the quality management system is at all times adequate and efficacious.* (Regulations-Schedule 3, Part 1.3(2)(f), Part 4.3(2)(f) or Part 5.3(2)(f)). An undertaking (in writing) by the manufacturer to notify the Secretary, or the Australian sponsor, of any information of the kind mentioned in subparagraphs 1.4(3)(c), 4.4(3)(c), or 5.4(3)(c) (for Parts 1, 4 or 5 CA procedures respectively), that the manufacturer becomes aware of in relation to the kind of medical device.* (Regulations-Schedule 3, Part 1.3(2)(g), Part 4.3(2)(i) or Part 5.3(2)(i)). For official use only Page 24 of 38

For each kind of device Copy this table for each kind of medical device as defined by the Therapeutic Goods Act 1989, Section 41BE. Information Location of information in supplied supporting Results of the risk analysis process and how the risks identified have been controlled to an acceptable level. This typically would include the final risk management report, any associated risk analysis, and details on how the risk acceptability criteria have been determined. (ISO 14971:2007) Results of the risk analysis process and how the risks identified have been controlled to an acceptable level. This typically would include the latest risk management report, any associated risk analysis, and details on how the risk acceptability criteria have been determined (i.e., by reference to clinical performance requirements according to the attended purpose of the device). Please note that reference to requirements specified in a technical standard would not normally be sufficient in of itself for demonstrating the clinical justification of risk acceptability. (ISO 14971: 2007) List of standards a. b. c. d. List the standards that have been complied with in full or in part in the design and manufacture of the device. A discussion of the standards considered for the device and support for their selection or omission. At a minimum, the above should include the standard organisation, standard number, standard title, year/version, and if full or partial compliance claimed. If partial compliance, a list of the sections of the standard that: i. Are not applicable to the device, and/or ii. have been adapted, and/or iii. were deviated from for other reasons discussion to accompany For official use only Page 25 of 38

Information Location of information in supplied supporting Clinical evidence (EP14, Regulation 3.11, Schedule 3, Part 8). This should include the following: a. Clinical trial data (where applicable). b. Clinical literature review (where applicable). c. A clinical evaluation report written by an expert in the relevant field that contains an objective critical evaluation of all of the clinical data submitted in relation to the device. d. A complete curriculum vitae, or similar, to justify the manufacturer s choice of the clinical expert. Labelling and instructions for use Advertising material For all devices (excluding IVDs) containing medicinal substance(s) Applicable Y N Information Location of information in supplied supporting Details of whether the medicinal substance(s) have been previously used in therapeutic goods supplied in Australia (i.e., ARTG entry, detail ARTG inclusion) Details of whether the Drug Master File(s) have been submitted to the TGA (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) Details of quality and safety data regarding medicinal requirements for new chemical entities (e.g., chemical and pharmaceutical data, toxicology, etc-for further guidance, please see ARGMD Part 2 <http://www.tga.gov.au/industry/devices-argmd.htm>) Details of the TGA GMP clearance for the medicinal-substance manufacturer(s) For official use only Page 26 of 38

For all devices (excluding IVDs) containing material of animal, microbial or recombinant origin Applicable Y N Information Location of information in supplied supporting Details of quality management system records of the assessment and control of the subcontractors that source the manufacturer with materials Details of evidence to demonstrate compliance with Conformity Assessment Standard Order 2 for devices containing materials of animal origin Details of information on source and manufacturing process of materials Details of evidence to minimise risks for transmission of pathogens For all sterile devices (excluding IVDs) Applicable Y N Information Location of information in supplied supporting Sterilisation validation reports (including method/process) Sterilisation residue report(s), where applicable Details of information on source and manufacturing process of materials Details of evidence to minimise risks for transmission of pathogens For all reusable devices (excluding IVDs) Applicable Y N Information Location of information in supplied supporting Evidence of cleaning and sterilisation method/process instructions Evidence of cleaning and sterilisation validation reports For official use only Page 27 of 38

Information Location of information in supplied supporting Evidence of information to be provided by the manufacturer for the processing of re-sterilisable medical devices (EN ISO 17664 or equivalent or better) For all devices incorporating software Applicable Y N Evidence that the manufacturer has met the applicable EPs by, for example, demonstrating compliance with: Location of data in supplied supporting IEC 62304 - Software lifecycle process (or equivalent or better) IEC 62366 - Useablity engineering (or equivalent or better) For electrical and electronic devices Applicable Y N Evidence that the manufacturer has met the applicable EPs by, for example, demonstrating compliance with: Location of data in supplied supporting IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (or equivalent or better) IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: 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, including details of: Location of data in supplied supporting Adverse events (GHTF / EU / TGA reportable) Advisory notices (particularly recall, notices) and alerts or field safety corrective action, Summary of clinical trial data For official use only Page 28 of 38

A concise summary of post-market performance data, including details of: Location of data in supplied supporting Summary of other clinical data (e.g., customer surveys) Approvals in other regulatory jurisdictions Has any device in this application been rejected or the application been withdrawn from any other regulatory authority or body? If yes, provide the location of the details of the rejection in the supplied supporting data Location of details of previous correspondence with the TGA regarding the application For MRA CE certificates Applicable Y N The TGA can only issue CE certificates to manufacturers established within Australia. For a manufacturer to be eligible for a CE certificate under the Australia-EU/EFTA MRAs the manufacturer must demonstrate that the device is fully (or mostly) manufactured within Australia. Some kinds of devices are also excluded from the agreement, or are subject to confidence building activities. For further information refer to the Australian Regulatory Guidelines for Medical Devices <http://www.tga.gov.au/industry/devices-argmd.htm>, and for information about the amended MRA refer to the TGA website <http://www.tga.gov.au/about/international-eu-mra-amendments.htm>. Evidence that the manufacturer has met the applicable European requirements for: Location of information in supplied supporting Other European directives or policies that are relevant to the device. Refer to <http://ec.europa.eu/health/medical-devices/other-related-policies/index_en.htm>. Devices where technical or regulatory requirements in the EU differ from the requirements in Australia. For official use only Page 29 of 38

Evidence that the manufacturer has met the applicable European requirements for: Location of information in supplied supporting Requirements of the MDD that are to be included in the Manufacturer s Quality Management System. EU Essential Requirements by way of a checklist or gap analysis when compared with the Australian Essential Principles. <http://www.tga.gov.au/industry/devices-forms-ecmra-ep-checklist.htm>. Labelling and instructions for use in compliance with Annex 1, Clause 13 of MDD. Provide details if the device(s) contain(s) substances that are carcinogenic, mutagenic, or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC (Some phthalates must be disclosed on EU labelling). A translation procedure (MEDEV 2.5/5 Rev. 3). For official use only Page 30 of 38

Attachment 2: Substantial change checklist Please complete this section for: Substantial changes to the QMS for existing conformity assessment certificate(s) (Schedule 3, part 1, 3,4 or 5 only) Substantial changes to the design of an existing Unique product Identifier / Device (Schedule 3, Clause 1.6 (Design Examination) or part 2 (type Examination) only) Copy this attachment for each kind of medical device as defined by the Therapeutic Goods Act 1989, Section 41BE. You are required to provide the data location details (i.e. where the document is located within the supplied data package) when a section is checked as Applicable Y. Describe the provided substantial changes Description: Description of each change (if applicable) Location: Location of data in supplied supporting Description of substantial changes provided Change(s) relating to Applicable Y N manufacturer, supplier, or Quality Management System (QMS) Description (e.g., if the change affects the manufacturer details, the manufacturer facilities, the suppliers or subcontractors, or the quality management system) Location Change(s) relating to the Applicable Y N scope of a TGA conformity assessment certificate(s) Schedule 3, Description Part 1, 4 or 5 (e.g., if the intention is to extend the scope of a Schedule 3, Part 1, 4, or 5 certificate to add new GMDN codes, or for the introduction of substantial changes to products under a GMDN category) Location For official use only Page 31 of 38

Description of substantial changes provided Change(s) relating to the design, material, product or intended purpose (e.g., if the change affects the design, indications, etc. of a UPI (unique product) covered by a Schedule 3, Clause 1.6 or a Schedule 3, Part 2 certificate but it does not result in a new UPI). Applicable Y N Description Location Details of previous correspondence with the TGA regarding the application: For official use only Page 32 of 38

For all Quality Management System Applicable Y N You are required to provide the data location details (i.e. where the document is located within the supplied data package) when a section is checked as Y. Information Substantial change Location of information in supplied supporting Details of changes to Quality Manual (ISO 13485:2003, clause 4.2.2) te: At minimum, this must include a reference to documented procedures Details of changes to product requirements (specifications) for the product Details of changes to manufacturing stages (detailing manufacturing steps or service provided and party responsibility-i.e., named critical supplier or manufacturer s facility) Details of changes to processes where the resulting output cannot be verified by subsequent monitoring or measurement and the status of their validation (ISO 13485:2003, clause 7.5.2.1) Details of changes to essential principles checklist supplied <http://www.tga.gov.au/industry/devices-forms-essential-principleschecklist.htm>. te: Please include a separate Essential Requirements checklist (as per the MDD) if applying for CE Certification. Details of changes to review of risk management file for currency and relevance, including current copy of risk management report (ISO 14971:2007, clause 8) Details of changes to labelling and/or instructions for use Details of changes to advertising material For official use only Page 33 of 38

For all devices (excluding IVDs) containing medicinal substance(s) Applicable Y N Information Substantial change Location of information in supplied supporting Details of changes to suppliers (including which suppliers provide which services or materials for which products) Details of changes to production process Details of changes to production facilities (e.g. new equipment) Details of changes to drug master file Details of up-to-date GMP clearance status of supplier(s) Details of changes to drug substance and/or dose For all devices (excluding IVDs) containing material of animal, microbial or recombinant origin Applicable Y N Information Substantial change Location of information in supplied supporting Details of changes to suppliers that provide materials of animal, microbial and recombinant origin Details of significant change to production process Details of changes to material species origin For all sterile devices (excluding IVDs) Applicable Y N Information Substantial Location of information in change supplied supporting Details of changes to suppliers (including which suppliers provide which services for which products) Details of changes to sterilisation method/process For official use only Page 34 of 38

Information Substantial change Location of information in supplied supporting Details of changes to sterile production facilities (e.g. new clean room, new equipment) For each device Applicable Y N Information Substantial change Location of information in supplied supporting Details of concise summary of all design and production changes Detailed description of any safety related design or production changes (e.g. in response to adverse event or recall) Details of any changes to the intended purpose of the device For each device Applicable Y N Information Location of information in supplied supporting Results of the risk analysis process and how the risks identified have been controlled to an acceptable level. This typically would include the final risk management report, any associated risk analysis, and details on how the risk acceptability criteria have been determined. (ISO 14971:2007) Results of the risk analysis process and how the risks identified have been controlled to an acceptable level. This typically would include the latest risk management report, any associated risk analysis, and details on how the risk acceptability criteria have been determined (i.e., by reference to clinical performance requirements according to the attended purpose of the device). Please note that reference to requirements specified in a technical standard would not normally be sufficient in of itself for demonstrating the clinical justification of risk acceptability. (ISO 14971: 2007) For official use only Page 35 of 38

Information Location of information in supplied supporting List of standards a. List the standards that have been complied with in full or in part in the design and manufacture of the device. b. A discussion of the standards considered for the device and support for their selection or omission. c. At a minimum, the above should include the standard organisation, standard number, standard title, year/version, and if full or partial compliance claimed. d. If partial compliance, a list of the sections of the standard that: i. Are not applicable to the device, and/or ii. have been adapted, and/or iii. were deviated from for other reasons - discussion to accompany Clinical evidence (EP14, Regulation 3.11, Schedule 3, Part 8). This should include the following a. Clinical trial data (where applicable). b. Clinical literature review (where applicable). c. A clinical evaluation report written by an expert in the relevant field that contains an objective critical evaluation of all of the clinical data submitted in relation to the device. d. A complete curriculum vitae, or similar, to justify the manufacturer s choice of the clinical expert. Labelling and instructions for use Advertising material For official use only Page 36 of 38

Attachment 3: Recertification checklist Complete this attachment when applying for recertification of existing conformity assessment certificates of any kind. You are required to provide the data location details (i.e. where the document is located within the supplied data package) when a section is checked as Applicable Y. Quality Management System CA certificates (TGA, Schedule 3, Parts 1, 4, and 5) Applicable Y N Material Location of data in supplied supporting Certificate to be recertified (Provide a copy of the certificate) Confirm certificate details (i.e., Manufacturer s name, address, facilities, suppliers, scope, conditions) Surveillance Inspection reports with non-conformity close-out since certification. Design/Type exam certificates (TGA, Schedule 3, Part 1 clause 1.6, and Part 2) Applicable Y N Material Location of data in supplied supporting Certificate to be recertified (Provide a copy of the certificate) Confirm certificate details (i.e., Manufacturer s name, address, facilities, scope, devices, conditions) (te: Indicate any devices not to be recertified) Post-market data Details of any reportable adverse events, recalls or notices from within or outside Australia since certification including device ARTG numbers For official use only Page 37 of 38

Material Location of data in supplied supporting Updated risk management report demonstrating continual compliance with the Essential Principles/Requirements; taking into consideration: experience gained post market additional information on existing and new hazards with regard to the state of the art (e.g., standards) and updated clinical data new regulatory developments For official use only Page 38 of 38