Fees and charges: summary - from 1 July 2018

Version 1.1, October 2018

12 October 2018

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IVD medical devices

The TGA website has information about IVD regulation basics.

Sponsoring IVDs

Annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 2018.

Class of IVD Charge Regulation
All classes of IVD excluding Class 4 in-house IVDs $670 7(4) (e)
Class 4 in-house IVDs n/a 7(4) (f)

n/a: not applicable

Notification fee

Laboratories that manufacture Class 1, Class 2 or Class 3 in-house IVDs are required to provide a notification to the TGA. These in-house IVDs are not required to be included in the ARTG.

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class of IVD Notification fee Item in Schedule 5 Part 1
Notification by a laboratory of its Class 1, Class 2 or Class 3 in-house IVDs $1,020 Item 1.17

Application fees

These fees are to apply to include an IVD in the ARTG. Application audit assessment fees are often payable as well. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990.

For guidance on variations go to Varying entries in the ARTG - medical devices and IVDs.

Application Application fee Item in Schedule 5 Part 1
Application for inclusion into the ARTG of all classes of IVD, including Class 4 in-house IVDs and export-only IVDs $1,020 Item 1.5(h), Schedule 5 Part 1 Therapeutic Goods (Medical Devices) Regulations 2002
Variation to an ARTG inclusion entry $450 Item 2A(g) Schedule 9 Part 2 Therapeutic Goods Regulations 1990

Application for medical devices (priority applicant) determination

This fee is for applicants seeking Priority Review designation for an application to include an IVD in the ARTG. This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

Application type Application fee Item in Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device (including an IVD) $9,840 Item 1.5A

Application audit assessment fees

An application audit assessment fee is payable in addition to the application fee for the inclusion of some medical devices in the ARTG.

Go to IVD guidance documents: Application audit (technical file review) and Regulatory requirements for in-house IVDs for more details.

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Type of IVD Assessment fee Item in Schedule 5 Part 1
Class 1, Class 2 and Class 3 IVDs $6,850 Item 1.14A
Class 4 in-house IVDs $63,400 Item 1.14B
Class 4 in-house immunohaematology reagent IVD $15,400 Item 1.14C

Manufacturing IVDs

Application for conformity assessment

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

All conformity assessment procedures Fee Item in Schedule 5 Part 1
Application fee $1,000 Item 1.1

Application for conformity assessment (priority applicant) determination

This fee is for applicants seeking Priority Review designation for an application for TGA conformity assessment of an IVD. This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

Application type Application fee Item in Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device (including an IVD) $9,840 Item 1.1A

Initial assessment of conformity assessment

In addition to the application fee, one or more of the following fees will apply to your kind of medical device.

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.

Type of conformity Fee Item in Schedule 5 Part 1
Full quality management system inspection: Schedule 3, Part 1 $29,800 Item 1.9A(a)
Design examination: Schedule 3, Clause 1.6 $63,400 Item 1.9A(b)
Design examination - immunohaematology reagent: Schedule 3, Clause 1.6 $15,400 Item 1.9A(c)
Type examination: Schedule 3, Part 2 $41,100 Item 1.9A(e)
Production quality management system inspection: Schedule 3, Part 4 $26,200 Item 1.9A(f)

Review of certificate of conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.

Type of certificate being reviewed Fee Item in Schedule 5 Part 1
Full quality management system inspection: Schedule 3, Part 1 $29,800 Item 1.3A(a)
Design examination: Schedule 3, Clause 1.6 $63,400 Item 1.3A(b)
Design examination - immunohaematology reagent: Schedule 3, Clause 1.6 $15,400 Item 1.3A(c)
Type examination: Schedule 3, Part 2 $41,100 Item 1.3A(e)
Production quality management system inspection: Schedule 3, Part 4 $26,200 Item 1.3A(f)

Other IVD conformity assessment fees

Conformity assessment fees are in Schedule 5, Therapeutic Goods (Medical Devices) Regulations 2002.

Other assessment for IVD conformity assessment Fee Item or paragraph in Schedule 5
Supplementary additional assessment in addition to assessment mentioned in item 1.2, 1.3A, 1.9A or 1.10A [item 2.1(b), Schedule 5] $420/assessor hour Item 1.12
Costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia costs and reasonable expenses Paragraph 2.1(a)
Surveillance assessment for conformity assessment certificate under Schedule 3, Part 1 or 4 $8,670 Item 1.2(b)
Assessment of changes to IVD or QMS for applicable IVD $17,800 Item 1.10A(a)
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate $6,850 Item 1.14A

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