Fees and charges: summary - from 1 July 2018

Version 1.0, July 2018

8 June 2018

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Other listed and registered therapeutic goods (OTGs)

Other listed and registered therapeutic goods (OTGs) include:

OTGs are the goods that meet the definition of a therapeutic good, but do not meet either a definition of a medical device or a medicine or a biological.

In this section, we have only included fees and charges that directly apply to these goods.

For a complete list, go to the relevant legislation.

Annual charges

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

Type of OTG Charge Regulation
Listed OTG: tampons and disinfectants $840

Regulation 7(1)(c)(iii)

Regulation 7(2)(c)(iii)

Registered OTG - disinfectants $1,640

Regulation 7(1)(a)(iii)

Regulation 7(2)(a)(iii)

Listed OTG fees

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

Listed OTG fees Fee Item in Schedule 9 Part 2
Application fee $450 Item 3(a)
Variation fee $450 Item 2A(f)
Fee for evaluating documents and information relating to the safety of a listed therapeutic device $18,200 Item 9C

Registered OTG fees

These fees are in Therapeutic Goods Regulations 1990.

Registered OTG fee type Fee Item in Schedule 9 Part 2
OR, the regulation
Low level registered device - application fee $1,460 Item 2(b),(g)
Low level registered device - disinfectant initial evaluation fee $18,200 Item 5B
Low level registered device - variation processing fee $450 Item 2A(d)
Low level registered device - disinfectant variation initial evaluation fee $3,660 Item 6B
Clinical trial notification (CTN) $360 Item 14A
High level registered device - application fee $4,350 Item 2(c)
High level registered device - variation processing fee $450 Item 2A(e)
High level device - variation manufacturing and/or quality control - initial evaluation $9,080 Item 7(b)
High level registered device - variation manufacturing and/or quality control - concurrent evaluation $2,000 Regulation 45(11)(a-e)

Miscellaneous fees

This fee is in Schedule 9, Therapeutic Goods Regulations 1990.

Application type Fee Item in Schedule 9 Part 2
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. $470 Item 1A

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