We provide expert consulting services to support medical device manufacturers with TGA registration, ensuring efficient market entry in Australia. Our services include:

• Device Classification: Determining the correct classification of your device under TGA regulations to define applicable requirements.
• ARTG Inclusion: Preparing and submitting applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
• Sponsor Collaboration: Assisting in identifying and working with your Australian sponsor to ensure smooth communication with the TGA.
• Technical Documentation: Reviewing and preparing compliant technical files, including safety, performance, and risk management evidence.

We offer specialized consulting services to help medical device manufacturers obtain Conformity Assessment Certificates from the Therapeutic Goods Administration (TGA). Our services are designed to guide you through the certification process efficiently and effectively.

Our Services for TGA Conformity Assessment Certification included:

1. Regulatory Pathway Determination
2. Gap Analysis
3. Technical Documentation Preparation
4. QMS Compliance Support
5. Application Preparation and Submission
6. Audit Preparation and Support
7. Non-Conformance Resolution
8. Post-Certification Support

We provide sponsorship services to medical device manufacturers, acting as their authorized representative in Australia. Our services include:

• Representation as Sponsor: Acting as your official Australian Sponsor, ensuring compliance with TGA requirements.
• ARTG Registration: Preparing, submitting, and managing the inclusion of your medical devices in the Australian Register of Therapeutic Goods (ARTG).
• Regulatory Compliance: Ensuring ongoing compliance with TGA regulations, including post-market obligations.
• Streamlined Communication: Managing interactions with the TGA on your behalf, including audits, inquiries, and regulatory updates.

With our expertise, manufacturers can confidently access the Australian market while meeting all regulatory obligations efficiently.