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Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

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IVD medical devices

The TGA website has information about IVD regulation basics.

Sponsoring IVDs

Annual charges

Table 57: Annual charges
Class of IVD Charge Regulation
All classes of IVD (excluding Class 4 in-house IVDs) $690 Item 7(4)(e)
Class 4 in-house IVDs n/a Item 7(4)(f)

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

Table 58: Notification fee
Class of IVD Notification fee Schedule 5 Part 1
Notification by a laboratory of its Class 1, Class 2 or Class 3 in-house IVDs $1,060 Item 1.17

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

Application fees

These fees are to apply to include an IVD in the ARTG. Application audit assessment fees are also often payable.

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

Table 59: Application fees
Application Application fee Regulation
Application for inclusion into the ARTG of all classes of IVD, including Class 4 in-house IVDs (excluding export only IVD devices) $1,060

Therapeutic Goods (Medical Devices) Regulations 2002,
Schedule 5 Part 1,

Item 1.5(h)

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

Table 60: Application for medical devices (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device (including an IVD) $10,200 Item 1.5A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

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.

Table 61: Application audit assessment fees
Type of IVD Assessment fee Schedule 5 Part 1
Class 1, Class 2 and Class 3 IVDs $7,130 Item 1.14A
Class 4 in-house IVDs $66,000 Item 1.14B
Class 4 in-house immunohaematology reagent IVD $16,000 Item 1.14C

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

Manufacturing IVDs

Application for conformity assessment

Table 62: Application for conformity assessment
All conformity assessment procedures Fee Schedule 5 Part 1
Application fee $1,040 Item 1.1

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

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.

Table 63: Application for conformity assessment (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device (including an IVD) $10,200 Item 1.1A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

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.

Table 64: Initial assessment of conformity assessment
Type of conformity Fee Schedule 5 Part 1
Full quality management system inspection: described in Schedule 3, Part 1 $31,000 Item 1.9A(a)
Design examination: described in Schedule 3, Clause 1.6 $66,000 Item 1.9A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $16,000 Item 1.9A(c)
Type examination: described in Schedule 3, Part 2 $42,700 Item 1.9A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $27,200 Item 1.9A(f)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Review of certificate of conformity assessment

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

Table 65: Review of certificate of conformity assessment
Type of certificate being reviewed Fee Schedule 5 Part 1
Full quality management system inspection: described in Schedule 3, Part 1 $31,000 Item 1.3A(a)
Design examination: described in Schedule 3, Clause 1.6 $66,000 Item 1.3A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $16,000 Item 1.3A(c)
Type examination: described in Schedule 3, Part 2 $42,700 Item 1.3A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $27,200 Item 1.3A(f)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Other IVD conformity assessment fees

Table 66: Other IVD conformity assessment fees
Other assessment for IVD conformity assessment Fee 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] $440/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 Item 2.1(a)
Surveillance assessment for conformity assessment certificate under Schedule 3, Part 1 or 4 $9,020 Item 1.2(b)
Assessment of changes to IVD or QMS for applicable IVD 60% of the relevant 'initial assessment' fee* under item 1.9A Item 1.10A
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate $7,130 Item 1.14A

Conformity assessment fees are in Schedule 5, Therapeutic Goods (Medical Devices) Regulations 2002
* for relevant 'initial assessment' fees

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