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Rest of World Submission Services

With IVD regulations varying from country to country, it can be difficult to navigate the intricate web of global requirements when launching new products. At Apotech, we streamline the process, offering specialist support for companies looking to adopt a multi-market approach. 

Expand your reach and enter new markets

Strategic global compliance for medical innovations

Markets across the world are constantly honing their regulatory standards to keep pace with advances in IVD technologies, bringing numerous compliance hurdles for manufacturers to overcome. This makes it all the more important to have a strategic approach in place, especially when launching new products globally. 

At Apotech, we can support you through every stage of the submission process, ensuring compliance with diverse regulatory requirements worldwide. Whether you are introducing innovative devices to established markets like the US, Europe and Japan or venturing into emerging markets such as China, Brazil, Australia, India and Mexico, our comprehensive services are tailored to pave the way for swift approvals and market access. 

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From navigating the complexities of individual country regulations to streamlining documentation for various markets, our team are experts in creating compliant and successful global regulatory submissions.

In maintaining a global presence, Apotech can assist IVD companies in registering their products worldwide. Our consultants offer specialised expertise in device registration and regulatory compliance, catering to markets like the US, Europe and the UK, as well as emerging markets including the Middle East, Africa and South America. 

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