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Fees and charges: summary from 1 July 2021

Version 1.0, June 2021

23 June 2021

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Medical devices

Medical devices are included (not listed or registered) in the ARTG.

Sponsoring medical devices

Annual charges

These charges are for inclusion of the following kinds of medical devices (other than medical devices produced for export) in the ARTG.

Table 41: Annual charges
Class of medical device Charge Regulation

AIMD

$1,210

Item 7(4)(d)

Class III

$1,210

Item 7(4)(d)

Class IIb

$950

Item 7(4)(c)

Class IIa

$950

Item 7(4)(c)

Class I - sterile

$650

Item 7(4)(b)

Class I - measuring function

$650

Item 7(4)(b)

Class I - other

$90

Item 7(4)(a)

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

Application fees

These fees are to apply to include a medical device in the ARTG. Application audit assessment fees are often payable as well. Application fees for export only devices are not included in this section.

Table 42: Application fees
Class of medical device Application fee Schedule 5 Part 1

AIMD

$1,380

Item 1.5(a)

Class III

$1,380

Item 1.5(b)

Class IIb

$1,070

Item 1.5(c)

Class IIa

$1,070

Item 1.5(d)

Class I - sterile

$1,070

Item 1.5(e)

Class I - measuring function

$1,070

Item 1.5(e)

Class I - other (excluding export only devices)

$560

Item 1.5(g)

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002
Note: Refer to export only device application fees

Application for medical devices (priority applicant) determination

This fee is for applicants seeking priority review designation for an application to include a medical device in the ARTG.

For guidance on how to seek priority review, go to Priority applicant guidelines for medical devices (including IVDs).

Table 43: 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

$10,300

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.

Table 44: Application audit assessment fees
Type of application audit Assessment fee Schedule 5 Part 1

Level 1 - verification of sponsor's application and evidence of conformity

$4,030

Item 1.13

Level 2 - Level 1 activities plus review of evidence of conformity

$7,390

Item 1.14

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

Variation fees

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

Table 45: Variation fees
Application type Application fee Schedule 9 Part 2

Variation to an ARTG inclusion entry

$470

Item 2A(g)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Miscellaneous

Table 46: Miscellaneous
Type of application Fee Schedule 5 Part 1

Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the ARTG (as described in item 1.6)

$7,390

Item 1.14

Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device, including an IVD medical device, for a single entry in the register

$500 (for all the devices to which the application relates)

Item 1.15(a)

Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device, including an IVD medical device, for a two or more entries in the register

$500 for the first entry,

plus $100 for each additional entry

Item 1.15(b)

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

Conformity assessment bodies designation determination

These applications have both an application fee and an assessment fee.

Table 47: Conformity assessment bodies designation determination
Application type Application fee Assessment fee Regulation

Full designation conformity assessment body determination

$4,710

$76,900

Item 1.4A and Item 1.4D

Partial designation conformity assessment body determination (full QMS)

$2,590

$55,200

Item 1.4B and Item 1.4E

Partial designation conformity assessment body determination (partial QMS or partial devices)

$2,590

$55,200

Item 1.4C and Item 1.4F

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

Manufacturing medical devices

Information about conformity assessment is in Australian regulatory guidelines for medical devices.

Application for conformity assessment

Table 48: Application for conformity assessment
All conformity assessment procedures Fee Schedule 5 Part 1

Application fee

$1,050

Item 1.1

This fee is 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 a medical device.

Table 49: 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

$10,300

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 50: Initial assessment of conformity assessment
Type of conformity Fee for initial assessment Schedule 5 Part 1

Full quality management system inspection (described in Schedule 3, Part 1)

$31,200

Item 1.9(a)

Design examination (described in Schedule 3, Clause 1.6)

$61,300

Item 1.9(b)

Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2)

$42,700

Item 1.9(c)

Verification (including management of testing, analysis, and reporting on verification tests) (described in Schedule 3, Part 3)

$29,900

Item 1.9(d)

Production quality management system inspection (described in Schedule 3, Part 4)

$27,300

Item 1.9(e)

Product quality management system inspection (described in Schedule 3, Part 5)

$23,300

Item 1.9(f)

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

Changes to conformity assessment

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

Table 51: Changes to conformity assessment
Type of conformity Fee for change Schedule 5 Part 1

Full quality management system inspection (described in Schedule 3, Part 1)

$18,800

Item 1.10(a)

Design examination (described in Schedule 3, Clause 1.6)

$37,000

Item 1.10(b)

Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2)

$25,800

Item 1.10(c)

Production quality management system inspection (described in Schedule 3, Part 4)

$16,200

Item 1.10(d)

Product quality management system inspection (described in Schedule 3, Part 5)

$14,200

Item 1.10(e)

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

Surveillance inspections - conformity assessment

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

Table 52: Surveillance inspections - conformity assessment
Type of surveillance inspection Fee Schedule 5 Part 1

Full quality management system surveillance inspection (described in Schedule 3, Part 1)

$9,060

Item 1.2(a)

Production quality management system surveillance inspection (described in Schedule 3, Part 4)

$9,060

Item 1.2(a)

Product quality management system surveillance inspection (described in Schedule 3, Part 5)

$9,060

Item 1.2(a)

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 53: Review of certificate of conformity assessment
Type of certificate being reviewed Fee Schedule 5 Part 1

Design examination re-assessment (described in Schedule 3, Clause 1.6)

$55,400

Item 1.3(a)

Type examination re-assessment (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2)

$42,700

Item 1.3(b)

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

Additional inspection fees

For medical devices that incorporate a medicine, application and evaluation fees apply for the medicine component as well as fees related to assessing the device.

Table 54: Additional inspection fees
Inspection costs Fee Schedule 5 Part 2

Supplementary additional assessment conducted outside Australia in addition to assessment mentioned in item 1.2, 1.3, 1.9 or 1.10, Schedule 5

$440/hour/assessor

Item 2.1(b)

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)

Cost of testing incurred in purchasing, establishing and setting up the equipment to be used to conduct the tests and the direct costs of conducting the tests (including the cost of any consumables used to conduct the tests)

At cost

Item 2.2

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

Issuing quality systems certificates

Table 55: Issuing quality systems certificates
Certificate Fee

Quality systems certificate

$180

Certified copy of quality systems certificate

$70

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