Your Trusted TGA Sponsor in Australia
At Svante Medical, we serve as your dedicated TGA Sponsor, providing essential regulatory support for medical device and IVD companies seeking to enter the Australian market. Our services ensure that your products comply with all local regulations, facilitating a smooth and efficient market entry.
Regulatory Representation
As your primary contact with the TGA, we handle all communications and regulatory submissions on your behalf.
Product Registration
We manage the entire TGA registration process, ensuring your medical devices and IVDs are approved efficiently.
Expert Regulatory Guidance
Our specialists provide ongoing advice and support, helping you navigate the complex regulatory landscape with ease.
Technical File Preparation
We compile and maintain your technical documentation, ensuring it meets TGA standards and is ready for inspection.
Labeling and Packaging
Our team ensures your product labels, packaging, and instructions comply with all Australian regulatory requirements.
Post-Market Surveillance and Vigilance
We monitor your products’ performance post-market, manage recalls and adverse event reporting, and ensure continued compliance.
Why Choose Us
At Svante Medical, we understand the unique challenges of the medtech industry. Our dedicated team is committed to guiding you through the regulatory landscape with ease and precision. With years of international expertise and a vast network, our team also serves as regulatory consultants, ensuring that your products meet global standards while seamlessly integrating into the Australian market. We collaborate closely with Johner Institute New Zealand, a leading regulatory consulting firm, and utilize the extensive global network of the Johner Institute to provide unparalleled support and expertise.
Expertise
With years of experience in the medtech industry, we have the knowledge and expertise to navigate complex regulatory landscapes.
Local Knowledge
Our deep understanding of Australian regulations ensures your product meets all necessary standards.
Client-Centric Approach
We prioritise our clients’ needs, offering tailored solutions and dedicated support.
Proven Track Record
We have a successful history of helping medtech companies bring their products to the Australian market.
Why You Need a TGA Sponsor
For medical device and IVD manufacturers outside Australia, appointing an Australian Sponsor, or TGA Sponsor, is essential. The Sponsor facilitates the registration process with the Therapeutic Goods Administration (TGA) and ensures ongoing compliance with local regulations.
Role of a Sponsor
- The TGA sponsor acts as a liaison with the TGA.
- Provides regulatory representation in Australia.
- Registers your device and ensures compliance.
Benefits of a Sponsor
- Maintains control over your device registration.
- Offers expert guidance during registration.
- Ensures ongoing compliance and surveillance.
Distributor vs Sponsor
- Distributors may focus on sales, causing conflicts.
- You might need to re-register if the distributor relationship ends.
- Distributors may not keep up with regulatory changes.