Authorized Manufacturer Representative in Russia

Foreign companies manufacturing medical equipment and seeking access to the Russian and Eurasian Economic Union (EAEU) markets are required to meet regulatory demands for official representation within the country. Adhering to these regulations is crucial for the registration of essential medical devices.

What is an Authorized Manufacturer’s Representative?

An Authorized Manufacturer’s Representative (AMR) acts as the regulatory and legal representative for foreign companies manufacturing medical equipment and looking to register it in Russia and EAEU countries. International manufacturers must appoint an AMR – either an individual or a legal entity, officially registered in Russia as per legal requirements. Upon obtaining registration certification, the AMR is accountable in Russia for the circulation of the medical device and compliance with mandatory requirements for medical devices.

Local Guidance from Qualified Experts

As seasoned specialists, NVR Consult Group offers services fully aligned with AMR requirements. Our experts understand the regulatory acts of Russia/EAEU, providing support to manufacturers from the initial medical device registration process through to ongoing compliance monitoring.

Comprehensive Support for Flawless Execution

We handle necessary applications, compile relevant reports, engage with medical device consumers regarding their quality, safety, and efficacy, and interact with regulatory bodies in the event of adverse incidents related to the use of the manufacturer’s medical devices in Russia.

Partner with verified professionals in the field of official manufacturer representation.

Don’t leave Russian registration obligations to chance. Work with proven Authorized Manufacturer Representation professionals today.