TGA Medical Device Compliance is a legal requirement for any business manufacturing, importing or supplying medical devices in Australia. At Compliance Wise Consulting, we help sponsors, overseas manufacturers and local suppliers meet TGA regulations, ARTG inclusion requirements and post-market obligations.

We guide you through classification, conformity assessment, technical documentation and ongoing compliance so you can focus on innovation while we manage the regulatory process. As a result, your devices are market-ready, legally compliant and supported by strong technical evidence.

 

1. TGA Classification & Regulatory Strategy

  • Identifying the correct medical device classification (Class I, IIa, IIb, III, AIMD, IVD).

  • Developing a clear regulatory strategy for market entry.

  • Explaining sponsor vs manufacturer responsibilities.

4. Technical Files & TGA Documentation

  • Creating and reviewing technical files for devices and IVDs.

  • Preparing clinical evaluation reports (CERs) and ISO 14971 risk documentation.

  • Ensuring labelling and IFUs meet TGA standards.

2. Conformity Assessment & Essential Principles

  • Preparing technical documentation for TGA conformity assessment.

  • Demonstrating compliance with Essential Principles.

  • Supporting audits and communication with the TGA.

5. Post-Market Surveillance & Vigilance

  • Designing post-market monitoring and reporting systems.

  • Managing adverse event reporting, CAPA and recall procedures.

  • Ongoing TGA compliance updates and therapeutic goods vigilance.

3. ARTG Inclusion & Medical Device Registration

  • Managing Australian Register of Therapeutic Goods (ARTG) applications.

  • Supporting sponsor, manufacturer and authorised representative obligations.

  • Handling overseas manufacturer CE/FDA evidence and mutual recognition pathways.

6. TGA Training & Compliance Advisory

  • Training your team in TGA requirements and obligations.

  • Updating you on regulatory changes and industry standards.

  • Providing advisory support for product changes, submissions and recalls.