Fees and charges: summary - from 1 July 2018

Version 1.0, July 2018

8 June 2018

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Medical devices

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

Sponsoring medical devices

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

Class of medical device Charge Therapeutic Goods (Charges) Regulations 1990
AIMD $1,160 Regulation 7(4) (d)
Class III $1,160 Regulation 7(4) (d)
Class IIb $900 Regulation 7(4)(c)
Class IIa $900 Regulation 7(4)(c)
Class I - sterile $620 Regulation 7(4)(b)
Class I - measuring function $620 Regulation7(4)(b)
Class I - other $90 Regulation7(4)(a)

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 $1,310 Item 1.5(a)
Class III $1,310 Item 1.5(b)
Class IIb $1,020 Item 1.5(c)
Class IIa $1,020 Item 1.5(d)
Class I - sterile $1,020 Item 1.5(e)
Class I - measuring function $1,020 Item 1.5(e)
Class I - other, including export-only $530 Item 1.5(ea)

This fee is for applicants seeking Priority Review designation for an application to include a medical device in the ARTG. This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

For guidance on how to seek Priority Review go to Priority review designations medical devices (including IVDs).

Application type Application fee Item in Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device $9,840 Item 1.5A

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 $3,830 Item 1.13
Level 2 - Level 1 activities plus review of evidence of conformity $7,030 Item 1.14

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 $450 Item 2A(g)

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 $450 Item 1.15
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the ARTG $7,030 Item 1.6

Conformity Assessment Bodies designation determination

These applications have both an application fee and an assessment fee. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Application type Application fee Assessment fee Item in Schedule 5 Part 1
Full designation conformity assessment body determination $4,480 $73,100 Items 1.4A and 1.4D
Partial designation conformity assessment body determination (full QMS) $2,460 $52,500 Items 1.4B and 1.4E
Partial designation conformity assessment body determination (partial QMS or partial devices) $2,460 $52,500 Items 1.4C and 1.4F

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

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

All conformity assessment procedures Fee Item in Schedule 5 Part 1
Application fee $1,000 Item 1.1

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. This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

Application type Application fee Item in Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device $9,840 Item 1.1A

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 $29,700 Item 1.9(a)
Design examination: Schedule 3, Clause 1.6 $58,300 Item 1.9(b)
Type examination (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $40,700 Item 1.9(c)
Verification (including management of testing, analysis, and reporting on verification tests): Schedule 3, Part 3 $28,400 Item 1.9(d)
Production quality management system inspection: Schedule 3, Part 4 $26,000 Item 1.9(e)
Product quality management system inspection: Schedule 3, Part 5 $22,200 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 $17,800 Item 1.10(a)
Design examination: Schedule 3, Clause 1.6 $35,200 Item 1.10(b)
Type examination (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $24,500 Item 1.10(c)
Production quality management system inspection: Schedule 3, Part 4 $15,400 Item 1.10(d)
Product quality management system inspection: Schedule 3, Part 5 $13,500 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 $8,620 Item 1.2(a)
Production quality management system surveillance inspection: Schedule 3, Part 4 $8,620 Item 1.2(a)
Product quality management system surveillance inspection: Schedule 3, Part 5 $8,620 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 $52,700 Item 1.3(a)
Type examination re-assessment (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $40,700 Item 1.3(b)

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.

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 $420/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 $180
Certified copy of quality systems certificate $70

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