TGA Medical Device Compliance

At Compliance Wise Consulting, we specialise in helping medical device suppliers achieve and maintain full compliance with the Therapeutic Goods Administration (TGA) requirements in Australia. Whether you are a local manufacturer, an overseas supplier, or an authorised sponsor, navigating the complex TGA regulatory framework can be challenging.

Our expert team provides end-to-end medical device compliance consulting, ensuring your products meet the Australian Regulatory Guidelines for Medical Devices (ARGMD) and all applicable standards before entering the market. From classification and conformity assessment to post-market obligations, we streamline the process so your business can focus on innovation while we manage compliance.

With extensive experience in TGA submissions, medical device registration, and ongoing regulatory support, we help you reduce risks, avoid costly delays, and maintain trust with regulators and consumers.

Services We Provide – We offer a full suite of TGA medical device compliance services, including:

 

1. TGA Classification & Regulatory Strategy

  • Assessing your medical device risk classification (Class I, IIa, IIb, III, AIMD, IVD).

  • Developing tailored compliance and market entry strategies.

2. TGA Conformity Assessment Support

  • Preparing technical documentation and evidence for conformity assessment.

  • Guiding you through Essential Principles compliance.

  • Supporting audits and liaison with the TGA.

3. TGA Medical Device Registration & ARTG Inclusion

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

  • Assisting with sponsor and manufacturer responsibilities.

  • Handling overseas manufacturer evidence and mutual recognition pathways.

 

4. Technical File & Documentation Preparation

  • Preparing comprehensive technical files for medical devices and IVDs.

  • Clinical evaluation reports (CERs) and risk management documentation (ISO 14971).

  • Labelling and Instructions for Use (IFU) compliance.

5. Post-Market Surveillance & Vigilance

  • Establishing post-market monitoring systems.

  • Adverse event reporting and corrective action processes.

  • Ongoing compliance with TGA post-market requirements.

6. Regulatory Training & Compliance Advisory

  • Training for internal teams on TGA compliance obligations.

  • Regular compliance updates to meet evolving regulatory requirements.

  • Advisory services for product changes, recalls, and regulatory submissions.

Visit the TGA website: https://www.tga.gov.au/