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Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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Medical devices

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

Sponsoring medical devices

Table 41: Annual charges
Class of medical device Charge Regulation
AIMD $1,180 Item 7(4) (d)
Class III $1,180 Item 7(4) (d)
Class IIb $920 Item 7(4)(c)
Class IIa $920 Item 7(4)(c)
Class I - sterile $630 Item 7(4)(b)
Class I - measuring function $630 Item 7(4)(b)
Class I - other $90 Item 7(4)(a)

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

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 $1,340 Item 1.5(a)
Class III $1,340 Item 1.5(b)
Class IIb $1,040 Item 1.5(c)
Class IIa $1,040 Item 1.5(d)
Class I - sterile $1,040 Item 1.5(e)
Class I - measuring function $1,040 Item 1.5(e)
Class I - other (excluding export only devices) $540 Item 1.5(g)

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

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 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 $10,000 Item 1.5A

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

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 $3,910 Item 1.13
Level 2 - Level 1 activities plus review of evidence of conformity $7,170 Item 1.14

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

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 $460 Item 2A(g)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Table 46: Miscellaneous
Type of application Fee 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 $460 Item 1.15
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) $7,170 Item 1.14

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 $4,570 $74,600 Item 1.4A and Item 1.4D
Partial designation conformity assessment body determination (full QMS) $2,510 $53,600 Item 1.4B and Item 1.4E
Partial designation conformity assessment body determination (partial QMS or partial devices) $2,510 $53,600 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

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

Table 48: Application for conformity assessment
All conformity assessment procedures Fee Schedule 5 Part 1
Application fee $1,020 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 Item in Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device $10,000 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) $30,300 Item 1.9(a)
Design examination (described in Schedule 3, Clause 1.6) $59,500 Item 1.9(b)
Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) $41,500 Item 1.9(c)
Verification (including management of testing, analysis, and reporting on verification tests) (described in Schedule 3, Part 3) $29,000 Item 1.9(d)
Production quality management system inspection (described in Schedule 3, Part 4) $26,500 Item 1.9(e)
Product quality management system inspection (described in Schedule 3, Part 5) $22,700 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) $18,200 Item 1.10(a)
Design examination (described in Schedule 3, Clause 1.6) $35,900 Item 1.10(b)
Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) $25,000 Item 1.10(c)
Production quality management system inspection (described in Schedule 3, Part 4) $15,700 Item 1.10(d)
Product quality management system inspection (described in Schedule 3, Part 5) $13,800 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) $8,800 Item 1.2(a)
Production quality management system surveillance inspection (described in Schedule 3, Part 4) $8,800 Item 1.2(a)
Product quality management system surveillance inspection (described in Schedule 3, Part 5) $8,800 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) $53,800 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) $41,500 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.

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

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 $430/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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