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Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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IVD medical devices

The TGA website has information about IVD regulation basics.

Sponsoring IVDs

Annual charges

Table 56: Annual charges
Class of IVD Charge Regulation
All classes of IVD (excluding Class 4 in-house IVDs) $680 7(4)(e)
Class 4 in-house IVDs n/a 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 57: 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 $1,040 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 often payable as well.

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

Table 58: 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) $1,040 Therapeutic Goods (Medical Devices) Regulations 2002,
Schedule 5 Part 1,
Item 1.5(h)
Variation to an ARTG inclusion entry $460 Therapeutic Goods Regulations 1990,
Schedule 9 Part 2 Item 2A(g)

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 59: 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) $10,000 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 60: Application audit assessment fees
Type of IVD Assessment fee Schedule 5 Part 1
Class 1, Class 2 and Class 3 IVDs $6,990 Item 1.14A
Class 4 in-house IVDs $64,700 Item 1.14B
Class 4 in-house immunohaematology reagent IVD $15,700 Item 1.14C

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

Manufacturing IVDs

Application for conformity assessment

Table 61: Application for conformity assessment
All conformity assessment procedures Fee Schedule 5 Part 1
Application fee $1,020 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 62: 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) $10,000 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 63: Initial assessment of conformity assessment
Type of conformity Fee Schedule 5 Part 1
Full quality management system inspection: described in Schedule 3, Part 1 $30,400 Item 1.9A(a)
Design examination: described in Schedule 3, Clause 1.6 $64,700 Item 1.9A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $15,700 Item 1.9A(c)
Type examination: described in Schedule 3, Part 2 $41,900 Item 1.9A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $26,700 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.

Type of certificate being reviewed Fee Schedule 5 Part 1
Full quality management system inspection: described in Schedule 3, Part 1 $30,400 Item 1.3A(a)
Design examination: described in Schedule 3, Clause 1.6 $64,700 Item 1.3A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $15,700 Item 1.3A(c)
Type examination: described in Schedule 3, Part 2 $41,900 Item 1.3A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $26,700 Item 1.3A(f)

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

Other IVD conformity assessment fees

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

Table 65: 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] $430/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 $8,850 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(a)
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate $6,990 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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