Guidance for IVD sponsors - a roadmap to market

11 March 2011

This road map is intended for Australian sponsors of IVDs, and presents an overview of the requirements for supplying an IVD under the new regulatory framework. The appropriate pathway is determined by the manufacturer's classification of the IVD.

Please note: This roadmap is a work-in-progress and additional information links will be added as details become finalised.

Abbreviations used in this roadmap

  • TGA = Therapeutic Goods Administration
  • QMS = Quality Management System
  • ARTG = Australian Register of Therapeutic Goods

Guidance for IVD sponsors - a roadmap to market

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Text version of Guideance for IVD sponsors - a roadmap to market

This text representation of this flowchart is provided as a list with numbered steps.

  1. In Vitro Diagnostic Device (IVD)1
  2. New sponsor applies for E-business account (only required once)2
  3. Sponsor obtains IVD classification from manufacturer3
  4. Class 1 IVD?
    1. 4.1 - No: Go to Step 5
    2. 4.2 - Yes: Sponsor obtains Global Medical Device Nomenclature (GMDN) from the manufacturer4
    3. 4.3 - Manufacturer's evidence5 is not required to be submitted to the TGA. A Declaration of Conformity6 to Australian requirements must be submitted to the TGA if requested.
    4. 4.4 - IVDs of the 'same kind of medical device' can be included on the ARTG under a single medical device application9
    5. 4.5 - Sponsor submits a medical device application through eBusiness Services (application fee applies)10
    6. 4.6 - TGA checks the submitted medical device application for completeness
    7. 4.7 - Mandatory Technical File Review (TFR) required?11
      1. 4.7.1 - No (no fee): Selected by TGA for a non-mandatory TFR or application audit?
        1. 4.7.1.1 - No: go to Step 7
        2. 4.7.1.2 - Yes (no fee): go to 4.7.2.1
      2. 4.7.2 - Yes (fee applies)
        1. 4.7.2.1 - TGA requests supporting information. Sponsor is invoiced an assessment fee if application is undergoing a mandatory TFR12
        2. 4.7.2.2 - Sponsor submits requested information within 30 working days (and pays fee if required)
        3. 4.7.2.3 - TGA reviews the submitted information
        4. 4.7.2.4 - Go to Step 7
  5. Class 2 & 3 IVD?
    1. 5.1 - No: Go to Step 6
    2. 5.2 - Sponsor obtains Global Medical Device Nomenclature (GMDN) from the manufacturer4
    3. 5.3 - Is Class 2 or 3 IVD manufactured in Australia?
      1. 5.3.1 - Yes: Go to Step 6
    4. 5.4 - No: Sponsor obtains from manufacturer a copy of the manufacturer's evidence5. A Declaration of Conformity6 to Australian requirements must be submitted to the TGA if requested.
    5. 5.5 - Sponsor submits manufacturer's evidence through eBusiness Services (no fees apply)8
    6. 5.6 - Manufacturer's evidence accepted?
      1. 5.6.1 - No: Suitable manufacturer’s evidence must be accepted to proceed - END FLOWCHART
    7. 5.7 - Yes: IVDs of the 'same kind of medical device' can be included on the ARTG under a single medical device application9
    8. 5.8 - Sponsor submits a medical device application through eBusiness Services (application fee applies)10
    9. 5.9 - TGA checks the submitted medical device application for completeness
    10. 5.10 - Mandatory Technical File Review (TFR) required?11
      1. 5.10.1 - No (no fee) - Selected by TGA for a non-mandatory TFR or application audit?
        1. 5.10.1.1 - No: go to Step 7
        2. 5.10.1.2 - Yes (no fee): go to Step 5.10.2.1
      2. 5.10.2 - Yes (fee applies)
        1. 5.10.2.1 - TGA requests supporting information. Sponsor is invoiced an assessment fee if application is undergoing a mandatory TFR12
        2. 5.10.2.2 - Sponsor submits requested information within 30 working days (and pays fee if required)
        3. 5.10.2.3 - TGA reviews the submitted information
        4. 5.10.2.4 - Go to Step 7
  6. Class 4 IVD?
    1. 6.1 - Yes: Sponsor obtains Global Medical Device Nomenclature (GMDN) from the manufacturer4
    2. 6.2 - Sponsor submits the TGA CA certificate (for QMS) as manufacturer's evidence through eBusiness Services (no fees apply)8
    3. 6.3 - Manufacturer's evidence accepted?
      1. 6.3.1 - No: Suitable manufacturer’s evidence must be accepted to proceed – END FLOWCHART
    4. 6.4 - Yes: IVDs of the 'same kind of medical device' can be included on the ARTG under a single medical device application9
    5. 6.5 - Sponsor submits a medical device application through eBusiness Services (application fee applies)10
    6. 6.6 - TGA checks the submitted medical device application for completeness
    7. 6.7 - Go to Step 7
  7. TGA includes the IVD(s) on the Australian Register of Therapeutic Goods (ARTG)13
  8. Sponsors and manufacturers have ongoing responsibilities once their products are included on the ARTG14
  9. End flowchart

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Footnotes (links to more information)

1. What is an IVD?

An IVD is any medical device which is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination (with other diagnostic goods for in vitro use), intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient or to monitor therapeutic measures.

2. New sponsor applies for E-business account (only required once)

Applications for inclusion on the Australian Register of Therapeutic Goods (ARTG) are submitted electronically through the eBusiness Services system. New users need to establish an e-business account to access eBusiness Services.

3. Sponsor obtains the IVD classification from the manufacturer

The manufacturer must classify the IVD according to the classification rules, based on the intended purpose of the IVD.

4. Sponsor obtains GMDN from manufacturer

The Global Medical Device Nomenclature (GMDN) is a collection of internationally recognised terms, each with a unique number that is used to accurately describe and catalogue medical devices. It is the responsibility of the manufacturer to assign the appropriate GMDN.

5. Requirements for manufacturer's evidence

Australian manufacturers of Class 2 and Class 3 IVDs must undergo conformity assessment by the TGA. All manufacturers of Class 4 IVDs to be supplied in Australia (including overseas manufacturers) must undergo conformity assessment by the TGA.

6. Declaration of Conformity

It is strongly recommended that sponsors obtain the manufacturer's Declaration of Conformity before submitting an application to include a medical device on the ARTG.

7. Conformity Assessment procedure for IVDs

A separate roadmap for manufacturers undergoing TGA conformity assessment is to be developed.

  • Conformity assessment procedures for IVDs guidance document (not yet available)
  • Essential Principles guidance document (not yet available)

8. Sponsor submits manufacturer's evidence through eBusiness Services

Only the QMS certificate should be submitted as manufacturer's evidence; the Declaration of Conformity and other information will be requested by the TGA when required. When submitting new evidence through eBusiness Services, ensure ALL product GMDNs applicable to the scope of that evidence are entered prior to finalising the submission. Once manufacturer's evidence has been accepted, details relating to the manufacturer, sponsor and GMDN codes will be linked to the medical device application as it is submitted through eBusiness Services (Step 10).

9. IVDs of the "same kind of medical device" can be included by a sponsor under a single medical device application

The "same kind" of medical device has

  • same sponsor
  • same manufacturer
  • same GMDN
  • same risk classification

Class 4 IVDs are only considered to be of the "same kind" if in addition to the above, they also have the same unique product identifier (UPI).

10. Sponsor submits an IVD application through eBusiness Services (application fee applies)

When lodging an application, the sponsor must certify the following:

  • the product is a medical device and is intended for a specific purpose
  • the IVD is correctly classified according to the rules
  • the IVD complies with the Australian essential principles for quality, safety and performance, and information is available to substantiate compliance
  • an appropriate conformity assessment procedure has been applied to the IVD and sufficient information is available to substantiate the application of the conformity assessment procedures
  • the IVD complies with advertising requirements
  • the IVD does not contain any substances prohibited from import into Australia
  • all information included in or with the application is complete and correct
  • there are procedures in place with the manufacturer to obtain and submit to the TGA any information requested, within 30 days. This may include evidence of compliance, the declaration of conformity etc.
    (Refer to the Therapeutic Goods Act 1989, Section 41FD)

Also see:

11. Mandatory Technical file review (TFR) required?

The following IVDs will undergo a mandatory TFR:

Any other application may be selected for a non-mandatory TFR

12. Sponsors are only invoiced an evaluation fee for IVDs undergoing a mandatory TFR

Applications that are selected by the TGA for a non-mandatory TFR or an application audit do not attract an evaluation fee.

13. TGA includes the IVD on the ARTG

14. Manufacturers and Sponsors have ongoing responsibilities once their products are included on the ARTG