Russia has 143,000,000 people and presents a potentially lucrative market for medical device companies. However, registration is challenging. Unlike most countries, Russia still relies on in-country product testing to grant 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 comprehensive article that explains how the process works, how long it will take and how much it will cost or download or approval process chart.
Russian medical device classification.
Medical devices in Russia are classified in much the same manner as Europe: Class I, IIa, IIb and III. The main agency overseeing medical devices in Russia is the Federal Service for Control over Healthcare and Social Development, more commonly known as "Roszdravnadzor."
Our team can help you with medical device registration in Russia.
Trying to navigate the Russian bureaucracy and language without the assistance of an experienced local representative generally leads to frustration. Emergo has the necessary contacts in the local market and can assist you with all aspects of medical device and IVD registration.
We can assist you with these medical device registration services for Russia:
- Advise on classification and family grouping of your devices in the Russian Federation.
- Coordinate with accredited testing labs within Russia on identifying required product testing and coordinating shipment of product samples to these facilities.
- Prepare technical file and registration application according to Russian regulations.
- Facilitate all testing (Technical, Toxicology, Metrological, etc.) necessary for registration of your device.
- Coordinate translation of the registration dossier and other technical documents into Russian.
- Submit application to Roszdravnadzor and assist with post-submission activities.
- Coordinate testing, application, and registration fees.
- Assist with clinical trial requirements according to Roszdravnadzor's requirements.
- Assist with obtaining Declaration of Conformity Certification (formerly referred to as GOST-R Certificate of Conformity) from Gosstandart.
Please contact us for more information on medical device registration in Russia.