Fees and charges: summary - from 1 July 2017

Version 1.0, June 2017

Book pagination

13 June 2017

Medical devices

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

Sponsoring medical devices

Annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Class of medical device Charge Therapeutic Goods (Charges) Regulations 1990
AIMD $1,140 Regulation 3(1B)(d)
Class III $1,140 Regulation 3(1B)(d)
Class IIb $880 Regulation 3(1B)(c)
Class IIa $880 Regulation 3(1B)(c)
Class I - sterile $610 Regulation 3(1B)(b)
Class I - measuring function $610 Regulation3(1B)(b)
Class I - other $80 Regulation3(1B)(a)

Application fees

These fees are to apply to include a medical device in the ARTG. Application audit assessment fees are often payable as well. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class of medical device Application fee Item in Schedule 5 Part 1
AIMD $1,290 Item 1.5(a)
Class III $1,290 Item 1.5(b)
Class IIb $1,000 Item 1.5(c)
Class IIa $1,000 Item 1.5(d)
Class I - sterile $1,000 Item 1.5(e)
Class I - measuring function $1,000 Item 1.5(e)
Class I - other n/a n/a

n/a: not applicable

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

Type of application audit Assessment fee Item in Schedule 5 Part 1
Level 1 - verification of sponsor's application and evidence of conformity $3,760 Item 1.13
Level 2 - Level 1 activities plus review of evidence of conformity $6,900 Item 1.14

Variation fees

These fees are in Schedule 9, Therapeutic Goods Regulations 1990. For guidance on variations go to Varying entries in the ARTG - medical devices and IVDs.

Application type Application fee Item in Schedule 9 Part 2
Variation to an ARTG inclusion entry $440 Item 2A(g)

Miscellaneous

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.
Type of application Fee Item in Schedule 5 Part 1
Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device that does not conform to the essential principles $440 Item 1.15
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the ARTG $6,900 Item 1.6

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

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

All conformity assessment procedures Fee Item in Schedule 5 Part 1
Application fee $980 Item 1.1

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 and the fees are in Schedule 5.
Type of conformity Fee for initial assessment Item in Schedule 5 Part 1
Full quality management system inspection: Schedule 3, Part 1 $29,100 Item 1.9(a)
Design examination: Schedule 3, Clause 1.6 $57,200 Item 1.9(b)
Type examination (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $39,900 Item 1.9(c)
Verification (including management of testing, analysis, and reporting on verification tests): Schedule 3, Part 3 $27,900 Item 1.9(d)
Production quality management system inspection: Schedule 3, Part 4 $25,500 Item 1.9(e)
Product quality management system inspection: Schedule 3, Part 5 $21,800 Item 1.9(f)

Changes to conformity assessment

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

Type of conformity Fee for change Item in Schedule 5 Part 1
Full quality management system inspection: Schedule 3, Part 1 $17,500 Item 1.10(a)
Design examination: Schedule 3, Clause 1.6 $34,500 Item 1.10(b)
Type examination (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $24,000 Item 1.10(c)
Production quality management system inspection: Schedule 3, Part 4 $15,100 Item 1.10(d)
Product quality management system inspection: Schedule 3, Part 5 $13,200 Item 1.10(e)

Surveillance inspections - conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.

Type of surveillance inspection Fee Item in Schedule 5 Part 1
Full quality management system surveillance inspection: Schedule 3, Part 1 $8,460 Item 1.2(a)
Production quality management system surveillance inspection: Schedule 3, Part 4 $8,460 Item 1.2(a)
Product quality management system surveillance inspection: Schedule 3, Part 5 $8,460 Item 1.2(a)

Review of certificate of conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.

Type of certificate being reviewed Fee Item in Schedule 5 Part 1
Design examination re-assessment: Schedule 3, Clause 1.6 $51,700 Item 1.3(a)
Type examination re-assessment (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $39,900 Item 1.3(b)

Additional inspection fees

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

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

Inspection costs Fee Paragraph in 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 $410/assessor hour Paragraph 2.1(b)
Costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia costs and reasonable expenses Paragraph 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 Paragraph 2.2

Issuing quality systems certificates

Certificate Fee
Quality systems certificate $170
Certified copy of quality systems certificate $60

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