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Consultants & Auditors

Overview​

Regulatory affairs (RA) professionals, consultants, notified body auditors, and quality management system auditors play a critical supporting role in Australian medical device regulation. While they do not themselves hold the legal obligations of manufacturers or sponsors, they directly shape whether their clients comply — and their advice, assessments, and decisions carry significant practical and professional consequence. This site is built with RA professionals as a primary audience.

What Consultants Do (and Don't) Hold Legally​

Regulatory consultants do not carry the legal obligations of the manufacturer or sponsor under the Therapeutic Goods Act 1989. Those obligations attach to the specific legal entities registered with the TGA. However, consultants who:

  • Act as authorised representatives on behalf of overseas manufacturers
  • Are named as contacts on TGA correspondence
  • Hold power of attorney or similar authority to act for a sponsor

...may take on practical responsibility that creates personal exposure if things go wrong.

Consultants advising on regulatory strategy, classification, conformity assessment pathways, or ARTG applications should be clear with their clients about the boundaries of their responsibility and the importance of the client themselves understanding and owning their regulatory obligations.

Common Consultant Activities​

RA professionals working in the Australian medical device space typically assist with:

  • Classification assessments — determining the correct device class under Schedule 2 or Schedule 2A of the MD Regulations
  • Regulatory pathway selection — advising on the most appropriate conformity assessment and ARTG pathway
  • Gap analyses — reviewing technical documentation, QMS, and clinical evidence against Australian requirements
  • Application preparation — preparing or reviewing ARTG inclusion applications and manufacturer evidence submissions
  • Post-market support — adverse event reporting, recall coordination, ARTG variation management
  • Acting as sponsor — some consultancies act as the Australian sponsor (authorised representative) for overseas manufacturers
  • Audit preparation — preparing clients for TGA audits or third-party QMS audits

Australian Conformity Assessment Bodies (CABs)​

Since July 2021, Australian companies have been able to apply to become Australian Conformity Assessment Bodies (CABs) — entities authorised to assess medical device manufacturers against the Essential Principles and issue conformity assessment certificates recognised by the TGA. This is a relatively new pathway that is expanding the domestic audit and certification capability in Australia.

For auditors working in or seeking to work in this space:

👉 Australian CAB information — TGA

Using This Site as a Reference​

RAPath is designed to be a reliable, well-structured reference for the regulatory requirements you navigate daily. Key features for RA professionals:

  • Legislation is the backbone — every topic page links to the specific section of the Act or Regulation it relates to, not just TGA guidance
  • Cross-referencing — pages link to related topics so you can trace requirements across pre-market and post-market obligations
  • Plain English summaries — to quickly orient to a topic before reading the underlying legislative text
  • Official source links — every page links directly to the TGA or legislation.gov.au source

If you identify an inaccuracy in any content on this site, please raise it via GitHub Discussions — your expertise directly improves the quality of this resource for the whole community.

Official Sources​