Application for Australian conformity assessment body determination form

Before submitting your application, please refer to the Guidelines to ensure that your corporation meets the eligibility criteria for determination as an Australian conformity assessment body.

To apply you must complete and submit this application form. An application fee is also payable. An application is not effective if it is not made in writing using this form, if the application fee is not paid, or if the application contains information that is false or misleading in a material particular.

For an application that is effective, the Therapeutic Goods Administration (TGA) will progress the application to an assessment and invoice you for the assessment fee (Note that this is a separate fee to the application fee). 

Terms used in this document:

Applicant: The Australian corporation making this application for a conformity assessment body determination.

Organisation: A group of related corporations or legal entities within Australia or outside of Australia with whom the “Applicant” has a business or legal relationship. Includes, for example, a parent, daughter (subsidiary), or sister company.

Subcontractor: An individual or entity, i.e. a separate company that is not an audit and certification organisation, that performs activities under contract, will be treated as a subcontractor for the purposes of Schedule 3AA of the Therapeutic Goods (Medical Devices) Regulations 2002.