Entering the medical device market of the Eurasian Economic Union (EAEU) has specific challenges. The registration process is quite complex, and legislation is still evolving, which means new requirements or changes take place regularly.  

Here are some of the difficulties that manufacturers or their authorized representatives are most likely to encounter: 

• Mandatory manufacturing sites inspections: for all high-risk medical products (2b and 3), plus sterile products of risk class 2a require a production inspection
• Necessity to conduct clinical trials with human participation: they are mandatory for about 45% of medical products (all MD of risk classes 2b and 3, all implantable MD, a new type of MD, fundamentally new materials of manufacture, new and complex techniques)
• Extended Timelines: the registration process can last from 12 months (for risk class 1 and non-sterile MD class 2a) or even from 28 months (for risk classes 2b and 3, implantable MDs)

Cooperating with a local partner is usually the main choice for international medical device companies entering the EAEU market. 

Inpharmatis expertise in the EAEU (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) regulatory environment provides you with comprehensive solutions for registration of medical devices. 

Inpharmatis regulatory affairs specialists keep up with the latest legal changes and updates, engage in strategic planning, prepare documentation, and communicate with the regional Regulatory Authorities. Inpharmatis local team guides you through every step, from the initial application to final approval, minimizing risks and simplify the registration process. 

Receive a personal offer for medical devices registration or request additional information about the service, reach out to us at info@inpharmatis.com.