You are here

What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs

Version 1.0, November 2011

24 November 2011

Book pagination

Parts 1 to 8

Part 1 Full quality assurance procedures (excluding Clause 1.6)

A manufacturer applies this procedure to Class 2, 3 and 4 IVDs and Class 4 in-house IVDs by implementing a full quality management system that takes into account the regulatory requirements for the:

  • design
  • production
  • packaging
  • labelling
  • final inspection processes
  • implementation of an ongoing monitoring system.

For IVDs assessed under Part 1, the manufacturer produces the technical documentation via the certified quality management system procedures for design and development (ISO 13485 clause 7.3). The production of the device is also performed via the quality management system.

Assessment by the TGA is carried out against the requirements of the Australian legislation. Assessment by overseas certification bodies against the relevant overseas legislation will be reviewed by the TGA for compliance with the Australian legislation.

The TGA will audit the quality management system (all clauses of ISO 13485 or equivalent standard), including an assessment of the manufacturer's technical documentation for the devices, which includes clinical evidence. The technical documentation must be available for review by the TGA who verifies its existence and completeness.

The conformity assessment certification remains valid only if it is subject to periodic and satisfactory surveillance audits.

Changes to the quality system that broaden its scope or substantially alter the approved system, design or production arrangements may require further assessment or approval by the conformity assessment body.

Once a manufacturer has obtained conformity assessment evidence under this Part they must then prepare an Australian Declaration of Conformity in accordance with clause 1.8 of Schedule 3 of the Regulations. For Class 4 IVDs and Class 4 in-house IVDs a clause 1.6 certificate is also required before the Australian declaration of conformity can be prepared.

Application of the procedures under Part 1 is recommended for manufacturers that produce IVDs in a range of classes including Class 2, 3 and 4 IVDs and Class 4 in-house IVDs who, on a regular basis:

  • Produce new devices; or
  • Improve or modify their devices.

However, Part 1 can be an onerous option for manufacturers that only produce Class 2 IVDs as it includes an assessment of design control and exceeds the minimum conformity assessment requirements for Class 2 IVDs.

Please note: Requirements for Full Quality Assurance under Part 1 are similar to the EU IVDD Annex IV requirements.

Part 1, Clause 1.6 Examination of design

This procedure applies to Class 4 IVDs and Class 4 in-house IVDs and requires the TGA to examine the design for each device. For a subsection of Class 4 IVDs and Class 4 in-house IVDs - currently IVDs to detect the presence of or exposure to HIV, HCV or HTLV - the TGA will require performance testing on Australian samples unless:

  • In the case of HIV and HCV, the IVD is currently registered in the ARTG and no significant changes have been made to the design since the device was subjected to performance testing for registration in Australia; or
  • In the case of HTLV, the manufacturer is able to supply performance data that in the opinion of the TGA is representative of the genotypic variants found in Australian samples.

The assessment is based on the design and development records produced under the manufacturer's quality management system and compiled/summarised into a 'design dossier'.

A separate certificate is required for each kind of medical device that is a Class 4 or Class 4 in-house IVD within the meaning of section 41BE of the Therapeutic Goods Act 1989 and Regulation 1.6 - see Kinds of IVD medical devices in the Section Including IVD medical devices in the ARTG.

Changes to the design or production of Class 4 IVDs and Class 4 in-house IVDs may also require further assessment or approval.

Re-examination of the design, which will be based on postmarket surveillance data, changes to relevant standards and any other changes that may affect compliance with the Essential Principles, will be required after 5 years.

Once a manufacturer has obtained conformity assessment evidence under this Part they must prepare an Australian Declaration of Conformity in accordance with clause 1.8 of Schedule 3 of the Regulations.

Please note: Requirements for Design Examination under Clause 1.6 are similar to the EU IVDD Annex IV.4 requirements.

Part 2 Type examination procedures

The options available for Class 3 and 4 IVDs and Class 4 in-house IVDs with this conformity assessment procedure are:

  • the TGA or EU Notified Body (for overseas manufacturers) will conduct tests on the device at the manufacturer's site and will supervise or commission the testing
  • the testing can be conducted within the TGA or an EU Notified Body's own laboratory
  • the TGA or EU Notified Body may subcontract the testing to an accredited testing laboratory (either in Australia or overseas).

The manufacturer must make an application for the TGA or an EU Notified Body, to examine a representative sample of the type of device (the 'type'). The type must:

  • have been designed and produced according to the Australian Essential Principles
  • be a finished device
  • be constructed of the same materials and manufactured in the same way as intended for general production.

The TGA will determine if the design of the type satisfies the Essential Principles. This will be done through examination of the supporting documentation and testing for compliance to a safety and performance standard, or standards applicable to the device. Testing or the supervision of the testing may occur on the manufacturer’s premises subject to the agreement of the manufacturer and the TGA or EU Notified Body.

The manufacturer must also seek further certification against Australian Part 4 - Production Quality Assurance Procedures.

Application of the procedures under Part 2 is recommended for manufacturers of Class 3 and 4 IVDs and Class 4 in-house IVDs who:

  • Do not currently have a design control system and do not wish to implement one in the future
  • Do not have a Design Dossier for their Class 4 IVD or Class 4 in-house IVD.

However, since any modification to the device would require an additional type examination this option is usually only feasible for manufacturers who do not intend to produce new versions or improve or modify their devices.

Please note: Requirements for Type Examination under Part 2 are similar to the EU IVDD Annex V requirements.

Part 3 Verification procedures

This procedure cannot be used for IVDs.

Part 4 Production quality assurance procedures

In this conformity assessment procedure, the manufacturer must implement a quality management system for the production and final inspection of Class 2, 3 and 4 IVDs and Class 4 in-house IVDs that specifically includes regulatory requirements and an ongoing monitoring system.

Assessment by the TGA is carried out against the requirements of the Australian legislation. Assessments by overseas certification bodies against the relevant overseas legislation will be reviewed by the TGA for compliance with the Australian legislation. The TGA will audit the quality management system (all clauses of ISO 13485 excluding design and development - clause 7.3, or equivalent standard), including an assessment of the manufacturer’s technical documentation for the devices.

Manufacturers of Class 3 and 4 IVDs and Class 4 in-house IVDs that have undergone a type examination under Part 2 must also apply the Part 4 conformity assessment procedures. When a Part 2 has been completed together with this part, manufacturers may then prepare an Australian Declaration of Conformity in accordance with clause 4.7 of Schedule 3 of the Regulations.

Manufacturers of Class 2 IVDs that have followed the procedure described in Part 6 may also use this procedure. For Class 2 IVDs a Declaration of Conformity is made under Part 6 with reference to the certification issued under Part 4, in accordance with clause 6.6 of Schedule 3 of the Regulations.

The certification only remains valid if it is subject to periodic surveillance.

Changes to the quality system that add additional kinds of products to the range covered, or that alter the approved system, may require further assessment or approval.

Combined with Part 6, assessment under this Part is recommended for manufacturers of Class 2 IVDs who produce new models of their devices, or improve or modify their devices on a regular basis and do not produce other devices of a higher class.

Please note: Requirements for Production Quality Assurance under Part 4 are similar to the EU IVDD Annex VII requirements.

Top of page

Part 5 Product quality assurance procedures

This procedure cannot be used for IVDs.

Part 6 Declaration of conformity (not requiring assessment by Secretary)

This part can be used for Class 1 and Class 2 IVDs.

In this conformity assessment procedure, the manufacturer of the device ensures that the device(s) comply with the Essential Principles and prepares documentation that allows the conformity to be self-assessed by the manufacturer.

The manufacturer is also required to implement an ongoing monitoring system.

For Class 2 IVDs the manufacturer must seek further certification against Part 4.

When a manufacturer has correctly applied this Part they should then prepare an Australian Declaration of Conformity in accordance with clause 6.6 of Schedule 3 of the Regulations.

Application of the procedures under this Part is recommended for manufacturers of Class 1 IVDs and (when combined with Part 4) manufacturers of Class 2 IVDs that do not produce other devices of a higher class.

Please note: Requirements for self-assessment and making a declaration under Part 6 are similar to the EU IVDD Annex III requirements.

Part 6A Procedures applying only to certain classes of in-house IVDs

This procedure applies to manufacturers of Class 1, 2 and 3 in-house IVDs.

To meet the requirements of this procedure the manufacturer (laboratory or laboratory network) must:

  • notify the TGA on a day no later than 1 July 2014 and then update on a day no later than each anniversary of the initial notification:
    • the contact details of the laboratory; and
    • the name and Class of all the in-house IVDs manufactured
  • meet the National Pathology Accreditation Advisory Council (NPAAC) performance standard Requirements for the Development and Use of In-house In Vitro Diagnostic Devices
  • be accredited as a medical testing laboratory by the National Association of Testing Authorities (NATA) or assessed by a conformity assessment body determined suitable by the TGA
  • meet the standard ISO 15189 Medical laboratories - Particular requirements for quality and competence.

The laboratory is required to hold information in relation to the quality management system, the design and manufacture of the in-house IVD and other documentation specified in the NPAAC standard, and to provide such documentation to the TGA if requested. This information will generally be reviewed as part of a laboratory's regular accreditation inspection by NATA.

The manufacturer is also required to implement a post-marketing system for the ongoing monitoring of the performance of the in-house IVD and to notify the TGA of any adverse events.

For more information please see Section - In-house IVDs

Part 7 Medical devices used for a special purpose

This procedure must be applied to systems and procedure packs.

To meet the requirements of this procedure the manufacturer must have documentary evidence to demonstrate that each of the medical device components, including each IVD, has:

  • met the Essential Principles
  • had the relevant conformity assessment procedures applied to it
  • make an Australian Declaration of Conformity in accordance with clause 7.5 of Schedule 3 of the Regulations
  • establish and maintain a post-market monitoring system.

For more information please see Section - Systems and procedure packs

Part 8 Clinical evaluation procedures

Every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the Essential Principles. For more information please see Section - Essential Principles - 14 Clinical Evidence

Top of page

Book pagination