Russia
Medical Device Registration
Medical device registration in Russia is a multi-step process that involves several regulatory bodies and a variety of regulations.
Regulatory Authorities
Roszdravnadzor, a regulatory agency under the Ministry of Health of the Russian Federation, oversees medical devices in Russia. This agency is supported by three Federal State Institutions (FGBUs), which are scientific expert organizations. The department within Roszdravnadzor that handles the registration and control of medical devices makes determinations about the approval or rejection of medical devices in Russia.
Medical Device Classification
In Russia, medical devices are classified by type and by risk and purpose associated with their use. The classification model is similar to the one used in the European Union. The classification include Class I, Class IIa, Class IIb, and Class III.
The rules of classification were separately established for the in vitro diagnosis
medical devices, according to the recommendations of the Group for Global
Harmonization of medical devices (GHTF/SG1/N045:2008).
| Classification | Risk Level | In Russian | Authorized Representative |
|---|---|---|---|
|
Class I |
Low Degree of Risk |
Класс I |
Yes |
|
Class IIa |
Average Degree of Risk |
Класс IIa |
Yes |
|
Class IIb |
Increased Degree of Risk |
Класс IIb |
Yes |
|
Class III |
High Degree of Risk |
Класс III |
Yes |
Registration Costs
The cost of the medical device registration process in Russia for one product is fairly low, ranging between $10,000 USD and $15,000 USD. The costs for efficiency, quality, and safety examination depend on the class of the device.
Registration Process
The registration time varies from 6 to 15 months depending on whether clinical trials are required.
These times are just estimates and can change based on how complex the device is and how complete the application is. It’s always smart to plan for extra time in case there are delays in the review process.
Partner with Accel!
Navigate the complexities of medical device registration with our expert services. We specialize in guiding manufacturers through the intricate process of registering their products with Roszdravnadzor, Russia’s Federal Service for Surveillance in Healthcare. Our team of professionals is well-versed in the documentation review and clinical data requirements set by Roszdravnadzor and its Expertise Center. We ensure your application is complete and accurate, significantly reducing the time for review. Whether your device requires clinical investigations or not, we streamline the process, making it as efficient as possible. Trust us to make your entry into the Russian market smooth and successful. Partner with us today for a hassle-free registration experience.
Our Expertise
Our team of subject matter experts cover your complete product life cycle needs across key geographies from preclinical discovery, product design and validation documentation, QMS regulatory affairs, clinical research, QMS/GMP and cybersecurity etc. We are here to accelerate your key countries market access with one-stop solution.
