svante medical

Medical Device
Sponsor, Representation, Registration, Consulting

Empowering Health, Innovating Futures – Your MedTech Sponsor for Australia.

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.

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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.

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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.

Let's Talk

Let’s collaborate to bring innovative medical technologies to market and improve healthcare.

Svante Medical, Australia

1/91 Smith St summer hill Sydney
NSW 2130 Australia
T: +61451329700
M: [email protected]

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Contacts

Office Address:

Svante Medical

1/91 Smith St summer hill Sydney

NSW 2130 Australia

 

Responsible for journalistic-editorial content:

Dorrin Asefi

Director Svante Medical

1/91 Smith St summer hill Sydney
NSW 2130 Australia