What medical devices require mandatory registration in Russia?
What is classified as a medical device in Russia?
According to Article 38 of Federal Law no. 323-FZ, medical devices include products intended for the diagnosis, prevention and treatment of diseases; monitoring a patient’s condition; conducting research; and restoring bodily functions
The following devices usually require registration:
How are medical devices classified?
In Russia, medical devices are divided into four risk classes (1, 2a, 2b, and 3). The class depends on the potential impact of the device on the patient, the duration of contact with the human body and the specifics of its use.
Low-risk devices include medical furniture and certain non-invasive products, while high-risk devices include pacemakers, implants and life-support systems. The higher the risk class, the more detailed testing and more extensive registration documentation are required
Is state registration always mandatory?
State registration is mandatory for most medical devices, regardless of risk class. Exceptions include devices manufactured to an individual patient’s order.
A separate procedure applies to unregistered medical devices imported into Russia for testing, research or registration. In such cases, the applicant must notify Roszdravnadzor via the Unified Portal of Public Services.
In Russia, medical device registration under Eurasian Economic Union (EAEU) rules is also being developed, although many companies still use the national procedure through Roszdravnadzor.
What documents are required for registration?
To complete registration, the manufacturer prepares a registration file. It usually includes
The requirements for the list of documents are set out in clauses 64–65 and 87 of the Rules for State Registration of Medical Devices approved by Government Decree no. 1684.
For certain device categories, Roszdravnadzor may request additional materials, such as information on biological safety or clinical evaluation.
To enter the Russian market, foreign companies need to complete product registration and find local partners—including distributors, manufacturers, logistics and service companies. Sber’s services help companies develop business relationships and find suppliers and partners for operating in the Russian and Indian markets.
How long does registration take?
The registration timeline depends on the risk class of the device and whether clinical studies are required. For certain low-risk devices, the administrative part of the procedure may take around 31 working days after the documents have been accepted for review.
In practice, the full registration cycle—including file preparation, testing and assessment—takes from several months to a year or more.
Is it possible to sell medical devices without registration?
The sale and use of unregistered medical devices in Russia are prohibited. Violations may result in administrative fines, the withdrawal of products from circulation and the suspension of business activities, as well as criminal liability in some cases.
Where should foreign manufacturers start?
First, a foreign manufacturer needs to determine the device’s risk class and understand which requirements will apply to registration, including whether clinical studies, a manufacturing site inspection or additional testing are required.
After that, it is necessary to appoint an authorised representative in Russia who will liaise with Roszdravnadzor and submit the documents.
For many international companies, registration is the first step in a broader market entry strategy, alongside local production, partner search and supply chain development. For more details on how Indian pharmaceutical companies operate in Russia and which areas remain promising, see Manufacturing pharma in Russia: opportunities for Indian firms.