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Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

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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, except for medical devices mentioned in Table 42.

Table 41: Annual charges
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.

Table 42: Annual charges for medical devices listed on Prostheses List
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.

Table 43: Application fees
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).

Table 44: 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 $10,200 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.

Table 45: 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 $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.

Table 46: 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 47: 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.

Table 48: Conformity assessment bodies designation determination
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

Table 49: 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.

Table 50: 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 $10,200 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 51: 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) $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.

Table 53: 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) $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.

Table 54: 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) $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.

Table 55: 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 56: Issuing quality systems certificates
Certificate Fee
Quality systems certificate $180
Certified copy of quality systems certificate $70

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