Global Regulatory Expertise

Global Regulatory Expertise


Strong global regulatory support is your passport to unlocking markets worldwide. At FiunEx, we offer a distinctive approach to simplify the complexities of regulatory support, enabling you to access markets around the world. Our services encompass a wide spectrum of healthcare product registration, marketing authorization approvals, clinical trial clearances, ethics committee approvals, and import permits.

FiunEx is a leading provider of global registration services for medical devices and in vitro diagnostics (IVD). Our team of experts is strategically located across Europe, the US, Italy, and China, with local associates extending our reach into South America, Asia, and the MEA region. We are well-equipped to manage registrations anywhere in the world.

Our professionals are well-versed in the latest regulations and requirements to ensure that your device meets all necessary standards for market entry. From pre-market assessments to post-market surveillance, FiunEx offers comprehensive support to guide you through the global regulatory landscape, ensuring your device's successful market entry.

Whether your goal is expanding into new territories or maintaining compliance with existing regulations, FiunEx is here to assist you on your regulatory journey. Partner with FiunEx to navigate the global regulatory maze and confidently bring your healthcare products to market successfully.



Global Regulatory Support

Health Canada Consulting

PMDA Japan Assistance

TGA Australia Support

NMPA Technical File Compilation and Submission

CDSCO India Support

ANVISA Brazil Consulting

UKCA Marking Services

ROW (Rest of World) Market Access