The article highlights the key points related to the regulatory framework for conformity assessment bodies designated to undertake the relevant procedures in Australia.
Table of content
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to determinations for Australian conformity assessment bodies. The document provides a general overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction
These guidelines are designed to assist Australian entities interested in becoming an Australian Conformity Assessment Body (Australian CAB). The document provides a comprehensive overview of the requirements, processes, and expectations associated with obtaining and maintaining CAB status under the Australian medical devices regulatory framework.
In particular, the present guidelines cover the following areas:
- Eligibility criteria
- Requirements for certification-related activities
- Requirements for Australian CABs
- Scope determination
- Application and determination process
- Determination decision
- Post-determination expectations
Under the general rule, an Australian CAB determination allows a corporation to operate under the Australian medical devices regulatory framework, as outlined in Chapter 4 of the Therapeutic Goods Act, 1989 (the Act) and the Therapeutic Goods (Medical Device) Regulations 2002 (the MD Regulations).
Certification Authority
As explained in the document, an Australian CAB, a company will be authorized to issue Australian conformity assessment body certificates to both Australian and overseas manufacturers of medical devices. These certificates support applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
CABs are responsible for ongoing monitoring and ensuring compliance with relevant conformity assessment procedures, including taking actions such as varying, suspending, or revoking certificates when necessary.
Requirements for Australian CABs
In order to be eligible for such a designation, an interested entity must meet several requirements, including:
- Continuous compliance with the determination requirements
- Keeping records of certification-related activities
- Notifying TGA about significant safety concerns or manufacturer activities
- Reporting events such as certificate suspension, revocation, or variation
- Providing information on request and participating in TGA reviews
Eligibility Criteria
In addition to the above, to be eligible for an Australian CAB determination, a company must:
- Be registered as an Australian corporation with the Australian Securities and Investments Commission (ASIC)
- Hold a valid Australian Company Number (ACN)
Application Requirements
The document further describes specific application requirements to be fulfilled by the interested party applying for designation as a conformity assessment body.
As explained by the TGA, all the applications should:
- Be in English and submitted using the TGA application form available on their website
- Be accompanied by the application fee
- Contain no false or misleading information
Assessment Criteria
As prescribed by the relevant legislation, the applications submitted by the interested parties will be assessed based on:
- Compliance with Schedule 3AA of the MD Regulations
- Whether the applicant or specified persons have met the “fit and proper person” criteria in paragraph 4A.6(3) of the MD Regulations, including no convictions for offenses involving fraud or dishonesty in the last 10 years
Other considerations include potential conflicts of interest or lack of independence due to previous services provided to the medical devices sector.
Certification-Related Activities
As it is also described in the guidance, Australian CABs may perform certification-related activities within Australia and overseas, including:
- Developing and approving the CAB’s quality management system (QMS)
- Reviewing and accepting applications from medical device manufacturers
- Assigning QMS auditors and product review teams
- Conducting regulatory reviews
- Making certification decisions
- Managing competencies of technical experts
The document also mentions that certain activities must be performed by qualified employees of your company and cannot be outsourced, such as:
- Reviewing qualifications and monitoring external experts
- Allocating work to external experts for specific activities
- Auditing and certification where subcontracting is to other auditing or certification organizations
- Final review and decision-making for issuing certificates
It is also stated that the applicant must have procedures and written agreements with contractors allowing TGA assessment-related activities. The authority additionally emphasizes that home offices are not considered critical locations unless designated as such.
Specific Aspects
Under the general rule, activities subcontracted or referred must not involve intermediaries. Written agreements with contractors or consultants should address confidentiality, conflicts of interest, and full responsibility for tasks performed.
An authorized TGA officer may inspect company or contractor premises to carry out assessment activities in Australia or overseas.
Conclusion
In summary, the present document provides a detailed process and requirements overview for applying to become an Australian CAB. It should be read alongside relevant legislation and other related guidelines published by the TGA in order to assist the entities interested in applying for CAB designation in ensuring compliance with the regulatory requirements they are subject to.
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