Australian Conformity Assessment Bodies (CABs) for Medical Devices – TGA Role and Framework

TGA's Role in Designating CABs

The Therapeutic Goods Administration (TGA) is responsible for designating Australian Conformity Assessment Bodies (CABs) to conduct conformity assessment procedures for medical devices as an alternative or complement to direct TGA assessment. Designated CABs perform evaluations equivalent to TGA processes, particularly for Quality Management System (QMS) certification (ISO 13485) and certain technical examinations. This framework supports efficient market access while maintaining high regulatory standards. Source: Australian Conformity Assessment Bodies (Australian CABs) - TGA

Types of Conformity Assessment Bodies

• Australian CABs: Bodies designated by the TGA to issue certificates accepted for Australian conformity assessment (primarily QMS-related).
• Overseas Bodies: TGA may accept certifications from certain international bodies under mutual recognition arrangements or equivalence determinations (e.g., EU notified bodies under transitional provisions).
• TGA as CAB: The TGA itself acts as a CAB for Australian manufacturers or when direct assessment is required.

Designation Criteria for Australian CABs

To be designated, a body must demonstrate:

• Accreditation to ISO/IEC 17021-1 (for QMS) or equivalent standards.
• Competence in medical device regulatory requirements.
• Impartiality, independence, and robust conflict-of-interest management.
• Procedures aligned with Therapeutic Goods (Medical Devices) Regulations 2002.
• Capability to assess compliance with Essential Principles and Australian-specific obligations.

Scope of CAB Activities

Designated CABs can perform:

• Full quality assurance system certification (ISO 13485 + Australian requirements).
• Production and/or product quality assurance assessments.
• Support for design/type examination when combined with TGA processes.

CAB certificates are used by manufacturers to support applications for TGA Conformity Assessment certification or direct ARTG inclusion for certain classes.

Application and Oversight

• Bodies apply for TGA designation via formal submission.
• TGA conducts rigorous assessment, including document review and on-site evaluations.
• Designation is time-limited with ongoing surveillance and re-assessment.
• TGA maintains a public list of designated CABs.

Benefits and Practical Use

• Reduces duplication for manufacturers already certified by designated CABs.
• Supports international alignment while ensuring Australian-specific protections.
• Manufacturers must verify CAB scope covers their device class and procedures before relying on certificates.

This CAB framework enhances regulatory efficiency for medical device conformity assessment in Australia. Detailed designation criteria, application forms, current list of designated CABs, and guidance on using CAB certificates are available in the official TGA page on Australian Conformity Assessment Bodies. Source: Australian Conformity Assessment Bodies (Australian CABs) - TGA

The system balances reliance on accredited bodies with direct TGA oversight to protect public health.