What a sponsor needs to know about conformity assessment and manufacturer's evidence for IVDs

7 March 2011

This Section should be read in conjunction with the Section Conformity assessment overview and Guidance for IVD sponsors - a roadmap to market.

Overview

Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that an IVD and the manufacturing processes used to make the IVD comply with the Essential Principles and other requirements of the therapeutic goods legislation.

The Australian sponsor is responsible for:

  • having procedures in place, including a written agreement with the IVD manufacturer, to obtain information from the manufacturer, when requested by the TGA
  • ensuring that
    • they have available sufficient information to substantiate compliance with the Essential Principles or have procedures in place to ensure that such information can be obtained from the manufacturer within 20 working days
    • an appropriate conformity assessment procedure has been applied to the IVDs by the manufacturer
    • the manufacturer has appropriate conformity assessment evidence for the IVD
    • the conformity assessment evidence remains valid while the device is supplied in Australia
  • obtaining a copy of the conformity assessment evidence from the manufacturer
  • submitting the conformity assessment evidence to the TGA
  • applying to include the device in the Australian Register of Therapeutic Goods (ARTG)
  • meeting all the ongoing monitoring and reporting requirements applicable to sponsors once a device is included on the ARTG. For more information see Section - Postmarket monitoring and vigilance
  • providing samples of the IVD to the TGA upon request
  • allowing a person authorised by the TGA to enter and inspect any premises, including outside Australia, where the devices are located
  • ensuring any advertising material relating to the IVD complies with the TGA requirements - for more information see Section - Information about a medical device.

Conformity assessment evidence accepted by the TGA

In accordance with the legislation, for IVDs manufactured outside Australia the TGA is able to accept the assessment of certification bodies that are considered to have the appropriate authority and expertise. There are IVDs that are exceptions to this determination (see TGA Conformity Assessment Certificates below).

The TGA accepts the following certificates and licences as conformity assessment evidence:

  • a Conformity Assessment Certificate issued by the TGA - this is mandatory for some manufacturers and IVDs in some classes (see TGA Conformity Assessment Certificates below)
  • EC certificates issued by an EU Notified Body under the EU In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC
  • an ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes certificate issued by:
    • a certification body that is also a Notified Body designated under the IVDD 98/79/EC
    • a CMDCAS (Canadian Medical Devices Conformity Assessment System) recognised Registrar
    • a certification body that is accredited by a signatory member of the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MRA) to undertake certification to ISO 13485
  • for Class 3 IVDs that are supported by an ISO 13485 certificate, a Class III or IV Medical Device Active Licence Listing (MDALL) that is issued by Health Canada under the Canadian Medical Devices Regulations.

Since the EU does not have a risk based classification system and the Canadian risk based classification rules are not identical to those in Australia, the conformity assessment requirements may be different in Australia. The manufacturer may be required to obtain additional conformity assessment evidence. Where the manufacturer is not able to obtain the appropriate additional conformity assessment evidence from their conformity assessment body, they may need to obtain a TGA Conformity Assessment Certificateorundergo additional review upon making an application for entry on the ARTG. This particularly applies to Class 3 IVDs that are manufactured overseas because both quality management certification and evidence of appropriate product review is required prior to entry of the IVDs in the ARTG.

Conformity assessment evidence that demonstrates that the manufacturer's quality management system has been audited by an acceptable certification body needs to be registered as Manufacturer's Evidence with the TGA for all IVDs, except Class 1 IVDs and Class 1, 2 and 3 in-house IVDs (See - Manufacturer's Evidence accepted by the TGA). Depending on the certification used and the Class of IVD, further conformity assessment evidence that specifically demonstrates product assessment may also need to be provided to the TGA at the time of submission of an application for inclusion in the ARTG; e.g. where an ISO 13485 certificate is submitted as Manufacturer's Evidence and used in an application for a Class 3 IVD.

The sponsor should ensure that they have the appropriate conformity assessment evidence for the IVDs before submitting the evidence to the TGA. The evidence should be carefully checked to ensure it is appropriate for the IVDs to avoid delays in submissions being processed - see following sections for guidance on appropriate evidence.

Multiple certificates may be required to cover all IVDs included in an application for entry in the ARTG. To accommodate this requirement, the application form for entry in the ARTG can be linked to multiple Manufacturer's Evidence submissions, with each Manufacturer's Evidence submission representing a single certificate.

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TGA Conformity Assessment Certificates

The TGA accepts TGA Conformity Assessment Certificates as Manufacturer's Evidence for any manufacturer. For details on how to apply for a TGA Conformity Assessment Certificate please see Section - What a manufacturer needs to know about conformity assessment for IVDs.

For some manufacturers and IVDs in some classes, the TGA can only accept TGA Conformity Assessment Certificates. These manufacturers and IVDs are:

  • Class 4 IVDs (including Class 4 in-house IVDs)
  • all Australian manufacturers1 except for manufacturers of the following:
    • Class 1 IVDs
    • IVD systems and procedure packs for which the special conformity assessment procedures have been applied
    • IVDs supplied to individuals:
      • as part of a clinical trial
      • through the Special Access Scheme
      • by Authorised Prescribers
      • by personal importation
    • exempt IVDs, including Class 1-3 in-house IVDs.

1 The TGA has sought comments on proposed changes to medical devices regulations including third party conformity assessments for Australian manufacturers. The consultation document can be found at: Consultation: Reforms in the medical devices regulatory framework.

EC certificates issued by an EU Notified Body

The TGA has determined that IVDD certificates issued by Notified Bodies may be accepted as Manufacturer's Evidence (See - Manufacturer's Evidence accepted by the TGA) and evidence of product review. An EC certificate may only be used if the IVD is included in the certificate's scope.

The following table provides the parallel references for the Australian and EU conformity assessment procedures:

Australian reference
Therapeutic Goods (Medical Devices) Regulations 2002
EU reference
IVDD 98/79/EC
Schedule 3 Part 1 - Full quality assurance procedures Annex IV
Schedule 3 Part 1, Clause 1.6 - Examination of design of Class 4 IVD medical device and Class 4 In-house IVD medical device Annex IV.4
Schedule 3 Part 2 - Type examination procedures Annex V
Schedule 3 Part 4 - Production quality assurance procedures Annex VII
Schedule 3 Part 6 - Declaration of conformity procedures Annex III

For some Class 2 and 3 IVDs covered by EC Certificates a mandatory application audit (technical file review) will be conducted once the sponsor lodges an application for inclusion in the ARTG with the TGA. The application audit is to confirm that the manufacturer of an IVD has carried out conformity assessment procedures appropriate to the classification of the device. For more information please see Section - Application audits of IVD medical device applications.

Some Notified Bodies in Europe may issue a special kind of CE certification known as "OEM Labelling", "Private Labelling" or "Own Brand Labelling". These certificates are issued to a manufacturer who re-labels another manufacturer's medical device that has CE certification. The TGA will accept CE certificates for "Own Brand Labelling" as Manufacturer's Evidence, without requiring additional information, provided the original manufacturer's CE certificate, quality management system documentation and product technical documentation are available on request.

The TGA will request the EC certificate of the original manufacturer and other documents during application audit or postmarket review of a device covered by an "Own Brand Labelling" certificate. Failure to provide the additional information is sufficient grounds for rejection/suspension/cancellation.

ISO 13485 certificates issued by a recognised body

The TGA has determined that ISO 13485 certificates issued by recognised bodies may be accepted as Manufacturer's Evidence. (See - Manufacturer's Evidence accepted by the TGA)

An ISO 13485 certificate:

  • covers the quality management system but does not include review of the product
  • does not provide assurance that the Australian legislative requirements (e.g. the Essential Principles) have been taken into consideration.

Therefore some applications to include IVDs in the ARTG that use ISO 13485 certification as Manufacturer's Evidence may be required, under the provisions of Regulation 5.3, to undergo additional pre-market review.

For Class 2 IVDs, ISO 13485 certificates are generally sufficient for entry of an IVD in the ARTG. Unless the device is selected for an application audit under any of the subparagraphs (1)(j)(i)-(vii) in Regulation 5.3, or for a non-mandatory application audit under section 41FH (1) (b), an application for a Class 2 IVD that uses an ISO 13485 certificate as Manufacturer's Evidence will not undergo additional pre-market review.

Under subparagraph (1)(j)(viii) in Regulation 5.3, Class 3 IVDs covered by an ISO 13485 certificate will be subject to a mandatory application audit once the sponsor lodges an application for inclusion in the ARTG. However if the sponsor provides evidence of a Class III or IV Medical Device Active Licence Listing (MDALL) issued by Health Canada under the Canadian Medical Devices Regulations for the Class 3 IVD (as an attachment to the device application form) the IVD will not normally be selected for an application audit under Regulation 5.3(l)(j)(viii). For more information please see Section - Application audits of IVD medical device applications.

Manufacturer's Evidence accepted by the TGA

For all IVDs, except Class 1 IVDs and Class 1, 2 and 3 in-house IVDs, the sponsor must submit Manufacturer's Evidence to the TGA and have it accepted before applying to include the IVD in the ARTG.

The TGA accepts the following certificates as Manufacturer's Evidence:

  • a Conformity Assessment Certificate issued by the TGA for Schedule 3 Part 1 (Full quality assurance) or Schedule 3 Part 4 (Production quality assurance) of the Therapeutic Goods (Medical Devices) Regulations 2002- this is mandatory for some manufacturers and IVDs in some classes
  • an EC certificate issued by an EU Notified Body for Annex IV.3 (Full quality assurance) or Annex VII (Production quality assurance) of the EU IVDD 98/79/EC
  • an ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes compliance certificate issued by a:
    • a certification body that is also a Notified Body for the purposes of the IVDD 98/79/EC
    • CMDCAS (Canadian Medical Devices Conformity Assessment System) recognised Registrar
    • a certification body that is accredited by a signatory of the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA) to perform ISO 13485 certification.

Details of the current IVDD Notified Bodies can be found at: Nando (New Approach Notified and Designated Organisations) Information System.

Details of the current CMDCAS recognised Registrars can be found at: List of registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR).

For a list of accreditation bodies that are signatories of the IAF, refer to IAF Members section at IAF (International Accreditation Forum).

The TGA does not accept certificates from the United States Food and Drug Administration (US FDA) as evidence that the Australian regulatory requirements have been met. This is because the US system does not align with the Australian regulatory framework.

For each class of IVD there are restrictions on type of certificates that may be used to demonstrate that a manufacturer has the appropriate manufacturing processes to make the IVD (Manufacturer's Evidence). These are shown on the following table.

Certificate issued under Certificate type Allowable Class of IVD
Therapeutic Goods (Medical Devices) Regulations 2002
(TGA)*
Schedule 3 Part 1
(Full Quality Assurance)
Class 4 IVD
Class 4 in-house IVD
Class 3 IVD
Class 2 IVD
Schedule 3 Part 4
(Production Quality Assurance)
Class 4 IVD
Class 4 in-house IVD
Class 3 IVD
Class 2 IVD
Directive 98/79/EC (IVDD)
(EU Notified Body)
Annex IV.3
(Full Quality Assurance)
Class 3 IVD
Class 2 IVD
Annex VII
(Production Quality Assurance)
Class 3 IVD
Class 2 IVD
ISO 13485
(CMDCAS recognised Registrar)
ISO 13485 Manufacturing and Design Class 3 IVD
Class 2 IVD
ISO 13485 Manufacturing excluding Design Class 2 IVD
ISO 13485
(certification body accredited by signatory of IAF MLA or a certification body that is also an EU Notified Body)
ISO 13485 Class 3 IVD
Class 2 IVD

* For Australian manufacturers2 and manufacturers of Class 4 IVDs, only TGA Conformity Assessment Certification is acceptable - see TGA Conformity Assessment Certificates

2 The TGA has sought comments on proposed changes to medical devices regulations including third party conformity assessments for Australian manufacturers. The consultation document can be found at Consultation: Reforms in the medical devices regulatory framework.

Certificates relating only to the design of the device are not accepted for submission as Manufacturer's Evidence. This includes Design Examination and Type Examination certificates issued by the TGA under Schedule 3 Clause 1.6 or Part 2 of the Australian regulations or a Notified Body under the IVDD Annex IV.4 or V. Where relevant, the TGA may require copies of such certificates to be electronically attached to the device application for inclusion or provided upon request during the application audit process.

There is no fee for submitting Manufacturer's Evidence. The TGA has a target time frame of 15 working days to consider and, where appropriate, accept the Manufacturer's Evidence. When an application for inclusion is received the TGA will check the Manufacturer's Evidence to ensure its relevance to the particular IVD(s) in the application.

The sponsor should check the details on the certificate to ensure it is appropriate for the IVD/s.See - What information should be on an EC/ISO 13485 certificate

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Manufacturer's declaration of conformity

The Declaration of Conformity includes details about the manufacturer and the IVDs and declares that the device complies with the applicable:

  • provisions of the Essential Principles
  • classification rules
  • conformity assessment procedures.

For Class 3 IVDs, the sponsor is required to provide the manufacturer's Australian Declaration of Conformity (DoC) as an attachment to the device application form. For other IVD classes, the sponsor may be requested to submit a copy of the DoC to the TGA, e.g. as part of an application audit or post-market review.

The DoC should not be submitted as Manufacturer's Evidence.

Submitting manufacturer's evidence

Before submitting Manufacturer's Evidence, the Australian sponsor must establish an eBusiness Services (eBS) account which is used to make electronic applications for medical devices including IVDs. The forms and instructions for establishing an eBS account can be found at http://www.ebs.tga.gov.au.

Once the sponsor has access to eBS, they must lodge an electronic submission to register the conformity assessment certification as Manufacturer's Evidence.

To do this, the sponsor should open their eBS portal view and select the option under Medical Devices to 'Manufacturer Evidence' and follow the prompts.

Guidance on completing the Manufacturer's Evidence form is available via the HELP button in the eBS form.

Please note: The lodgement process requires that an electronic copy of the certificate be attached to the submission.

It will help the sponsor ensure they are lodging the correct certificate if they have a copy of the manufacturer's Australian Declaration of Conformity to refer to when completing the electronic application.

Each certificate requires a separate lodgement as Manufacturer's Evidence.

Where the sponsor attaches multiple certificates, only the certificate that is detailed in the Manufacturer Evidence form will be considered for the lodgement.

Maintaining currency of manufacturer's evidence

Expired certificates

In most cases the manufacturers' certifications are current for 5 years from the last date of issue.

The expiry date as stated on the certificate is recorded on eBS. This expiry date may be used by the TGA to send reminder letters to sponsors advising that the Manufacturer's Evidence has expired and provide a timeframe for sponsors to submit updated evidence.

Variations to existing manufacturer's evidence

The information on the manufacturer's certificates may change over time and as a consequence the certification body will generally audit the facility and/or issue a revised certificate.

These revised certificates must be submitted to the TGA as a "variation to manufacturer's evidence" quoting the unique Manufacturer's Evidence ID number. Any changes to the certifications need to be incorporated in the variation notification form in eBS.

If there has been a change in manufacturer's name and/or site address, sponsors will need to attach documentation from the certification body which provides evidence of the change. This requirement is to prove to the TGA that the change in manufacturer's name and/or address is as a result of corporate changes only and not:

  • a result of a new manufacturer taking on responsibility for the production of the devices
  • an alternate manufacturer of the devices already included on the ARTG.

If either of the options listed above occur, the devices are regarded as a different kind of device under section 41BD of the Act and require new device applications to be submitted for the IVDs to be included in the ARTG.

Changes to existing manufacturer's certificates

The changes to existing manufacturer's certificates which can change over time include:

  • expanding the range of products covered under the scope of the certificate
  • reducing the range of products covered under the scope of the certificate
  • updating the:
    • certificate number following re-issue of a certificate
    • re-issue date following a surveillance audit and re-issue of the certificate
  • altering the conformity assessment procedures (change to the annex route)
  • changing the Notified Body or certification body undertaking the audit; or
  • amending the manufacturer's details (change to name and/or address).

The TGA needs to be advised if any of these changes occur. The process for updating this information is to submit a variation to Manufacturer's Evidence via eBS.

Next steps

The TGA will notify the sponsor via email if the Manufacturer's Evidence submission is successful.

If the submission is not accepted the sponsor will be notified by email, outlining the reasons for the rejection.

Once the evidence has been successfully submitted, the sponsor can then lodge an application to include an IVD in the ARTG. Please see Section - Including IVD medical devices in the ARTG.

What information should be on an EC/ISO 13485 certificate

There are a number of important details that a sponsor should check to ensure that the certificate is valid for particular IVDs. Wording and formatting will vary between certification bodies. Following is a mock-up of what an EC/ISO 13485 certificate should contain.

What information should be on EC/ISO 13485 certificates

Please note:

Certificates may reference attachments or additional information such as:

  • "see overleaf"
  • Annexes
  • Enclosures
  • Schedules
  • Addendums
  • IVDD product lists

This information MUST be provided with the certificate. If the certificate has page numbers then ALL pages must be provided.

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