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TGA Sponsorship

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Looking for a Reliable TGA Sponsor to Support Your Australian Business Expansion?

If your overseas business plans to import, manufacture, or sell therapeutic goods in Australia, appointing a domestic TGA sponsor is not just a requirement—it’s the key to entering and thriving in the market.

Abdera Business Services is here to make this process seamless. With over 20 years of experience in the health and medtech industries, we offer tailored TGA sponsor services to help you navigate the complex regulatory landscape and ensure your business complies with Australian standards.

Medical Technology

Choose Abdera for TGA Sponsor Services

  • Expert Guidance: Our team assists with the TGA Sponsor local representative, business expansion services.
  • Flexibility: We separate your commercial distribution from regulatory compliance, giving you freedom and control over your operations.
  • Comprehensive Support: Beyond TGA sponsorship, we offer Australian company setup, ACN/ABN registration, and director services.
  • Robust Agreements: Our watertight contracts ensure you retain control over your ARTG registrations and protect your business interests.
  • Industry Connections: We provide access to a vast network of experts, including regulatory affairs consultants, legal experts, financial institutions, and government contacts.
  • Global Expertise: Having worked with businesses from the US, UK, China, Singapore, and more, we understand the unique needs of international companies.

Launch Your Business for Success

Don’t let TGA compliance slow down your Australian expansion. Abdera is ready to be your trusted partner, ensuring you stay focused on growing your business while we handle the regulatory complexities.

We can’t wait to help you and your business. Call us on +61 2 8916 6259 or contact us and let’s get started. 

FAQs for TGA sponsor and TGA approval

Leading European Medical Device Company Case Study

Expanding into a new market can be complex, especially in a highly regulated industry like medical devices. Here’s how Abdera helped a leading European company navigate challenges and establish a strong foothold in Australia’s booming eHealth market. Read full case study.

TGA Sponsor – Frequently Asked Questions

A TGA (Therapeutic Goods Administration) sponsor is a legal entity responsible for ensuring that your therapeutic goods eg health and medical device complies with Australian regulatory requirements before it can be marketed and sold in Australia. The sponsor must be a resident of Australia with an Australian address and serves as the primary contact for the TGA. If there are any issues with the product, the TGA will contact the sponsor directly.

Australian law requires that all health and medical devices undergo TGA approval before entering the market. A sponsor ensures your product meets all regulatory requirements, including classification, safety, and performance standards.

It is advantageous for the Australian subsidiary to act as the TGA sponsor rather than the distributor because:

  • Direct Control: The Australian subsidiary retains control over the product’s regulatory compliance, ensuring standards are maintained without external influence.
  • Long-Term Stability: A distributor agreement may change or terminate, while an Australian subsidiary acting as the sponsor ensures continuous market access.
  • Regulatory Consistency: The subsidiary can directly manage compliance, risk classification, and product registrations, avoiding potential conflicts of interest with distributors.
  • Clear Accountability: The subsidiary, as the sponsor, is the primary contact for the TGA, ensuring streamlined communication and regulatory oversight.

Abdera Pty Ltd offers specialised TGA sponsorship services, including:

  • Acting as the TGA Sponsor: Representing your Australian entity and serving as the resident contact for TGA communications.
  • Managing TGA Business Portal: Administering the TGA business portal on behalf of the Australian company.
  • Local Representation: Acting as the authorised representative for overseas companies seeking market entry.

Abdera does not provide direct regulatory services but collaborates with experienced regulatory affairs agents to ensure your Australian subsidiary complies with TGA requirements and other statutory bodies.

Yes, Abdera specialises in supporting international health and medical device companies expand into Australia by:

  • Establishing an Australian subsidiary and ensuring ongoing compliance with TGA requirements. Yes, Abdera specializes in supporting international medical device companies expand into Australia by:
  • Acting as the local TGA sponsor and the resident director.
  • Assisting with market entry strategies.
  • Providing business setup and ongoing support, including company registration, legal and tax compliance.
  • Acting as your business advisor.

The duration varies depending on the device’s risk classification and the completeness of the submitted documentation. Abdera works closely with clients to streamline this process and ensure timely approvals.

Abdera offers:

  • Over 20 years of experience in international business expansion.
  • Comprehensive support from regulatory strategy to market entry and ongoing business management.
  • Personalised services tailored to the needs of health and medical device companies.

For more information on how Abdera can support your health and medical device expansion into Australia, contact us today.

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