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Fees and charges: summary from 1 July 2020
Version 1.3, November 2020
6 November 2020
Medical devices
Medical devices are included (not listed or registered) in the ARTG.
- For IVDs, go to IVD medical devices
- For export information, go to Device export certificates
- For clinical trials supplying unapproved medical devices, go to Clinical trials
- For guidance on medical devices, go to the Australian regulatory guidelines for medical devices.
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, except for medical devices mentioned in Table 42.
| Class of medical device | Charge | Regulation |
|---|---|---|
| AIMD | $1,200 | Item 7(4)(d) |
| Class III | $1,200 | Item 7(4)(d) |
| Class IIb | $940 | Item 7(4)(c) |
| Class IIa | $940 | Item 7(4)(c) |
| Class I - sterile | $640 | Item 7(4)(b) |
| Class I - measuring function | $640 | Item 7(4)(b) |
| Class I - other | $90 | Item 7(4)(a) |
These charges are in the Therapeutic Goods (Charges) Regulations 2018
Annual charges for medical devices listed on the Prostheses List
These charges are for inclusion of the following kinds of medical devices listed prostheses in the ARTG under Chapter 4 of the Therapeutic Goods Act 1989. A medical device is a listed prosthesis within the meaning of the Private Health Insurance (Prostheses) Rules (No 1) 2020, effective 7 April 2020.
These charges are only in effect for the financial year 1 July 2020 to 30 June 2021.
| Class of medical device | Charge | Regulation |
|---|---|---|
| AIMD | $600 | Item 7(4A)(b) |
| Class III | $600 | Item 7(4A)(b) |
| Class IIa | $470 | Item 7(4A)(a) |
| Class IIb | $470 | Item 7(4A)(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.
| Class of medical device | Application fee | Schedule 5 Part 1 |
|---|---|---|
| AIMD | $1,370 | Item 1.5(a) |
| Class III | $1,370 | Item 1.5(b) |
| Class IIb | $1,060 | Item 1.5(c) |
| Class IIa | $1,060 | Item 1.5(d) |
| Class I - sterile | $1,060 | Item 1.5(e) |
| Class I - measuring function | $1,060 | Item 1.5(e) |
| Class I - other (excluding export only devices) | $550 | 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 review designations medical devices (including IVDs).
| Application type | Application fee | Schedule 5 Part 1 |
|---|---|---|
| Medical devices (priority applicant) determination in relation to a medical device | $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.
| Type of application audit | Assessment fee | Schedule 5 Part 1 |
|---|---|---|
| Level 1 - verification of sponsor's application and evidence of conformity | $3,990 | Item 1.13 |
| Level 2 - Level 1 activities plus review of evidence of conformity | $7,310 | 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.
| 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
| 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) | $7,310 | 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 | $490 (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 |
$490 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.
| Application type | Application fee | Assessment fee | Regulation |
|---|---|---|---|
| Full designation conformity assessment body determination | $4,660 | $76,100 | Item 1.4A and Item 1.4D |
| Partial designation conformity assessment body determination (full QMS) | $2,560 | $54,600 | Item 1.4B and Item 1.4E |
| Partial designation conformity assessment body determination (partial QMS or partial devices) | $2,560 | $54,600 | 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 Part 1, Australian regulatory guidelines for medical devices. Fees are in Therapeutic Goods (Medical Devices) Regulations 2002.
Application for conformity assessment
| All conformity assessment procedures | Fee | Schedule 5 Part 1 |
|---|---|---|
| Application fee | $1,040 | 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.
| Application type | Application fee | Schedule 5 Part 1 |
|---|---|---|
| Conformity assessment (priority applicant) determination in relation to a medical device | $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.
| Type of conformity | Fee for initial assessment | Schedule 5 Part 1 |
|---|---|---|
| Full quality management system inspection (described in Schedule 3, Part 1) | $30,900 | Item 1.9(a) |
| Design examination (described in Schedule 3, Clause 1.6) | $60,700 | Item 1.9(b) |
| Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) | $42,300 | Item 1.9(c) |
| Verification (including management of testing, analysis, and reporting on verification tests) (described in Schedule 3, Part 3) | $29,600 | Item 1.9(d) |
| Production quality management system inspection (described in Schedule 3, Part 4) | $27,000 | Item 1.9(e) |
| Product quality management system inspection (described in Schedule 3, Part 5) | $23,100 | 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.
| Type of conformity | Fee for change | Schedule 5 Part 1 |
|---|---|---|
| Full quality management system inspection (described in Schedule 3, Part 1) | $18,600 | Item 1.10(a) |
| Design examination (described in Schedule 3, Clause 1.6) | $36,600 | Item 1.10(b) |
| Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) | $25,500 | Item 1.10(c) |
| Production quality management system inspection (described in Schedule 3, Part 4) | $16,000 | Item 1.10(d) |
| Product quality management system inspection (described in Schedule 3, Part 5) | $14,100 | 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.
| Type of surveillance inspection | Fee | Schedule 5 Part 1 |
|---|---|---|
| Full quality management system surveillance inspection (described in Schedule 3, Part 1) | $8,970 | Item 1.2(a) |
| Production quality management system surveillance inspection (described in Schedule 3, Part 4) | $8,970 | Item 1.2(a) |
| Product quality management system surveillance inspection (described in Schedule 3, Part 5) | $8,970 | 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.
| Type of certificate being reviewed | Fee | Schedule 5 Part 1 |
|---|---|---|
| Design examination re-assessment (described in Schedule 3, Clause 1.6) | $54,800 | 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) | $42,300 | 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.
| 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
| Certificate | Fee |
|---|---|
| Quality systems certificate | $180 |
| Certified copy of quality systems certificate | $70 |