Secure market readiness and compliance confidence for your medical devices and IVDs.
Optimize Compliance in Europe with MedEnvoy’s Regulatory Importer and In-Country Representative Services
Expert Regulatory Support for In-Country Representation and Regulatory Importer Services
We take pride in our proven track record of providing in-country representation and regulatory importer services to medical device and IVD manufacturers seeking to expand their reach in the European Union, United Kingdom, United States, Switzerland and beyond.
We have helped numerous clients navigate complex regulatory landscapes, streamline processes, and maintain compliance with ease. In our collection of case studies, you will hear real-world examples of how our expert regulatory team provides a comprehensive solution to the regulatory requirements.
MedEnvoy’s Importer Process:
Our Regulatory Importer services ensure ongoing compliance without
disrupting your supply chain.
We perform many tasks to ensure your ongoing compliance with the EU, UK, or Swiss regulations without the need to take title or take physical possession of your devices. Our compliance checks are done electronically and efficiently.
Our importer process does not disrupt the way you ship today.
Münsterbrücke, Zürich
MedEnvoy’s In-Country Representative Process:
Meet basic compliance requirements prior to product placement
in all European markets
The In-Country Representative’s role is to confirm basic compliance requirements and serve as a local point of contact for authorities should there be a problem with your product. With MedEnvoy as your representative, you are one step closer to ensuring regulatory compliance, placing products on the market, and ensuring positive patient outcomes.