Medical Device Approval in Russia
The Russian Federation has 140,000,000 people and is a potentially lucrative market for medical device companies. However, registration is challenging. Unlike most countries, Russia still relies on product testing in granting approval for medical devices and this testing must be completed regardless of whether the device already has US 510(k) clearance or European CE Marking.
For an in-depth overview of the Russia regulatory approval process for medical devices, read our 3700 word article that explains how the process works, how long it will take and how much it will cost.
Russian medical device classification.
Medical devices in Russia are classified in much the same manner as Europe: Class 1, 2a, 2b and 3. The main agency overseeing medical devices in Russia is the Federal Service for Control over Healthcare and Social Development, more commonly known as “Roszdravnadzor.” Within this agency is the Department of Registration of Foreign Medical Equipment and Devices (DRFMED).
Our team can help you with medical device registration/approval in Russia.
Trying to navigate the Russian bureaucracy and language without the assistance of an experienced local representative generally leads to frustration. Representatives at Roszdravnadzor prefer to do business in person (in Russian) and generally will not provide consultation by phone. Emergo Group maintains a local presence in Moscow and we can assist you with all aspects of medical device and IVD registration.
With help from Emergo Group, medical device registration can often be achieved in 3-8 months, depending on product classification and identification of predicate devices.
We can assist you with these medical device approval services for Russia:
• Schedule and attend face-to-face meetings with officials from the Department of Registration of Foreign Medical Equipment and Devices (DRFMED) within Roszdravnadzor.
• Coordinate with DRFMED on indentifying required product testing and coordinating shipment of product samples to special testing labs within Russia.
• Prepare registration file according to Russian regulations.
• Prepare all Reports (Technical, Toxicology, Electrical, Medical) necessary for registration of your device.
• Determinate classification and predicate (analog) equivalency in the Russian Federation.
• Coordinate translation of Instructions for Use (IFU) and other technical documents into Russian.
• Coordination of application submission to the Russian health ministry (Roszdravnadzor).
• Coordinate of testing, application and registration fees.
• Assistance obtaining GOST-R Certificate of Conformity and Sanitary-Epidemiological Conclusion (Hygienic Certificate).
