Conformity Assessment Certification: Supporting Data Form

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 <

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 application instructions <

IVD device applicants should refer to <

Please forward a completed copy of this form, together with all relevant supporting documentation (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.

/

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:

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: 1800446443
Fax: 02 6232 8426
Email:

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. <
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: <
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)*

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

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)
orSection 6: Device details (IVD only), depending on your device(s)
Attachment 1: New certificate checklist.

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

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

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

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. ‘
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
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

/ Note: 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 3.1of 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

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 Yes No

Certificate number / Notified body
Commencement date / Expiry date
Certificate type e.g. Annex IV
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 audit report in supplied supporting data (e.g. vol.1, section 3, p 10)

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 Yes No

Certificate number / Notified body
Commencement date / 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)

3.4.4.ISO 13485 certificates held by the manufacturer (IVD only)

Applicable Yes No

Certificate number / Issuing body
Commencement date / 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)

3.4.5.QMS certificate issued under the TGA / Health Canada MoU on QMS Certification for Medical Devices by a Canadian Registrar

Applicable Yes No

Certificate number / Canadian Registrar
Commencement date / 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)

3.4.6.Health Canada Class 3 and 4 product licences held by the manufacturer

Applicable Yes No

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)

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).
Note: 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])

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
(For Class III and class AIMD only)
For further information, refer to the Australian Regulatory Guidelines for Medical Devices <
List of variants e.g. diameter and length ranges
(For Class III and class AIMD only)
For further information, refer to the Australian Regulatory Guidelines for Medical Devices
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? / Yes No
Is the device single-use? / Yes No
Does the device incorporate a measuring function? / Yes No
Is the device an Active medical device? / Yes No
Does the device incorporate software? / Yes No

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.
Device incorporates a medicinal substance that has an action that is ancillary to the device / Yes No
Device incorporates an extract from human blood or plasma that has an action that is ancillary to the device / Yes No
Device incorporates material or substances of animal origin or was manufactured using materials of animal origin / Yes No
Device incorporates or was manufactured using material or substances of microbial origin / Yes No
Device incorporates material or substances produced using recombinant technology / Yes No

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:/
List of variants
(For Class 4 IVDs-Immunohaematology reagents only)
For further information, refer to IVD guidance documents <http:/
Classification
Refer to Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2A or to guidance documents
/ 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

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 Yes No

Information / Location of information in supplied supporting documentation

Design dossier

A compilation of Quality Management System design and development records showing conformity to essential principles. The design dossier should include documentation 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 documentationApplicable 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 documentation for review.

Information / Location of information in supplied supporting documentation
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)
Note: 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)-Schedule3, 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-Schedule3, Part 1 1.4(3), Part 4 4.4(3) or Part 5 5.4(3) and regulation 5.7-Uniform Recall Procedure).
Procedures for a corrective and preventive action system
(ISO 13485, clauses 8.5.2, 8.5.3; Regulations-Schedule3, 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-Schedule3, 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-Schedule3, 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-Schedule3, Part 1.3(2)(g), Part 4.3(2)(i) or Part 5.3(2)(i)).

For each kind of device