Australian Conformity Assessment Bodies (Australian CABs)

The determination of an Australian CAB requires:

• demonstrated competency
• recognition for undertaking medical device product assessments, and
• recognition for undertaking quality management system auditing.

We make sure medical devices are registered on the ARTG.

When required by law or at the request of a manufacturer, we do product assessments.

On 23 July 2021, the Australian Government decided to:

• repeal Regulation 4.1, and
• amend Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002.

These amendments have changed the requirements for medical devices that contain:

• medicines or materials of animal origin
• materials of microbial, recombinant, or human origin, and
• Class 4 in vitro diagnostic (IVD) medical devices.

For inclusion in the ARTG, device sponsors used to rely on our conformity assessments. This means they can use Australian CAB certificates or equivalent overseas regulator evidence.

See Changes to medical device regulations affecting when conformity assessment certificates are required.

Background

In the Therapeutic Goods Act 1989, we were given the power to authorise Australian companies to do conformity assessments. This is through an Australian CAB Determination.

In assessing and determining an Australian CAB, we will consider alignment with European requirements for a Notified Body and/or Auditing Organisation requirements for the Medical Device Single Audit Program.

We will rely on best practice documents and standards from IMDRF. This will make sure Australian CABs are in line with international standards.

Eligibility and guidelines

Applicants who want to become Australian CABs need to:

• register with the Australian Securities and Investments Commission (ASIC) as an Australian Corporation
• hold a current Australian Company Number (ACN)
• demonstrate the competence, independence and impartiality of personnel proposed to be involved in the organisation's certification-related activities in Australia, and
• demonstrate how they will perform certification-related activities consistent with the Australian regulatory framework.

We encourage applicants to meet with us before submitting an Australian CAB application. A pre-application meeting may help the applicant and Australian CAB program to:

• understand the requirements for seeking a determination as an Australian CAB
• identify issues to resolve before submitting an application, and
• plan for the application and manage timeframes and resources.

Pre-application meetings may be face-to-face or via teleconference.

To request a meeting see Pre-submission meetings with TGA for guidance. Complete the Request for pre-submission meeting form and email it to AUCAB@health.gov.au.

A meeting with us doesn't guarantee acceptance of the application. It also doesn't predict a determination decision.

Applicants should download the Pre-submission meeting record form. Use this to provide us with a record of the meeting. This should be no more than 2 weeks after meeting.

Our guidance at the meeting is nonbinding and without prejudice.

With time, the advice we gave at the meeting may become outdated or obsolete.

For eligibility criteria, see Determinations for Australian Conformity Assessment Bodies. This includes:

• the eligibility information
• the requirements for certification-related activities
• the requirements for Australian CABs
• scope of determination
• the application and determination process
• the determination decision
• what to expect once it's decided.

Application forms

Online application form

Application for Determination of Australian Conformity Assessment Bodies

Downloadable forms

Certificate under subregulation 4A.6(3) of the Therapeutic Goods (Medical Devices) Regulations 2002:

• Subregulation 4A.6(3) Certificate (pdf,186kb)
• Subregulation 4A.6(3) Certificate (docx,126kb)

Privacy

• General privacy information

Register of Australian Conformity Assessment Bodies

Getting a determination puts your company on the Register of Australian CABs.