Australian corporations can apply to become an Australian conformity assessment body (Australian CAB) for medical devices from 1 July 2021.
The determination of an Australian CAB requires demonstrated competency and recognition for undertaking medical device product assessments and quality management system auditing.
The Therapeutic Goods Administration (TGA) remains responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG). The TGA will continue to provide product assessments and quality management assessments when required by legislation or at the request of a manufacturer.
On 23 July 2021, the Australian Government made a decision to repeal Regulation 4.1 and amend Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002. These amendments have changed the conformity assessment certification and audit requirements for medical devices that contain medicines or materials of animal, microbial, recombinant or human origin; and Class 4 in vitro diagnostic (IVD) medical devices.
Before the change, under regulation 4.1, sponsors of such devices could only rely on conformity assessment certification by the Therapeutic Goods Administration (TGA) for inclusion in the Australian Register of Therapeutic Goods (ARTG) for these types of devices.
The TGA will now accept conformity assessment documents issued by an Australian CAB including those issued for medical devices that contain medicines or materials of animal, microbial, recombinant or human origin; and Class 4 in vitro diagnostic (IVD) medical devices.
For more information, see Changes to medical device regulations affecting when conformity assessment certificates are required.
Background
The Expert Review of Medicines and Medical Devices Regulation made recommendations aimed at streamlining the TGA's processes for including medical devices in the ARTG and to improve timely access to new medical devices by Australian consumers.
Amendments made to the therapeutic goods legislation enables the TGA to authorise Australian corporations to perform the assessments required by the conformity assessments procedures for medical devices. This will be implemented through an Australian CAB Determination.
In assessing and determining an Australian CAB, the TGA will consider alignment with European requirements for a Notified Body and/or Auditing Organisation requirements for the Medical Device Single Audit Program. The TGA will also utilise best practice documents and standards that are promoted by the International Medical Devices Regulators Forum (IMDRF). This is to ensure that any determination made and any ongoing management of Australian CABs aligns with international practices.
Eligibility and guidelines
To apply to become an Australian CAB the applicant must demonstrate:
- they are registered with the Australian Securities and Investments Commission (ASIC) as an Australian Corporation and hold a current Australian Company Number (ACN)
- the competence, independence and impartiality of personnel proposed to be involved in the organisation's certification-related activities in Australia
- how they will perform certification-related activities consistent with the Australian regulatory framework
Applicants are invited and encouraged to meet with the TGA prior to submitting their application for an Australian CAB determination. A pre-application meeting may be of assistance to the applicant and Australian CAB program to:
- understand the requirements for seeking a determination as an Australian CAB
- identify issues to resolve prior to submitting an application
- plan for the application and manage timeframes and resources.
Pre-application meetings may be face-to-face or via teleconference.
To request a meeting please see Pre-submission meetings with TGA for guidance. Complete the Request for pre-submission meeting form and email it to AUCAB@health.gov.au.
Acceptance of the meeting by the TGA does guarantee acceptance of the application or anticipate the outcome of the application for Australian CAB determination.
Applicants should download the Pre-submission meeting record form and use this to provide the TGA with a record of the meeting no more than 2 weeks after meeting.
Our guidance at the meeting is nonbinding and without prejudice.
As knowledge evolves over time, the initial guidance we gave at the meeting may become out of date or be superseded.
Refer to the Guidelines for Organisations applying for an Australian conformity assessment body determination to ensure you meet the eligibility criteria. These outline:
- the eligibility information
- the requirements for certification-related activities
- the requirements for Australian CABs
- how a determination is scoped
- the application and determination process
- the determination decision
- what to expect once a determination is made
Application forms
Online application form
Apply for an Australian conformity assessment body determination.
Application for Determination of Australian conformity assessment bodies
Downloadable forms
Certificate under subregulation 4A.6(3) of the Therapeutic Goods (Medical Devices) Regulations
Privacy
General privacy information relating to applications for Australian CAB determinations
Register of Australian conformity assessment bodies
Australian corporations granted an Australian CAB Determination will be included in the Register of Australian conformity assessment bodies.