Healthcare Resource Guide: Russia

Russia Statistics


Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process



Procurement & Tenders

Trade Events

CS Contacts

Best Prospects

Market Size

Capital: Moscow

Population: 146,880,432

GDP: $15,77.52 (2017)

Currency: Russian ruble

Language: Russian


Russia’s healthcare system is still evolving rapidly, creating many promising areas for U.S. medical equipment exports. It is currently estimated that only 20% of the Russian population of 146 million has access to quality healthcare. The majority of hospitals and polyclinics are public and belong to federal, regional or local governments.

At the moment, the two major sources of public healthcare funding - mandatory insurance funds (30%) and spending supported by federal and regional budgets (70%) - do not cover all healthcare expenses. As a result, a significant portion of overall (public and private) healthcare spending (about 20%) is covered out of patients’ pockets. Voluntary healthcare insurance programs account for approximately one-third of the total private healthcare expenditures. According to long-term reform plans, mandatory insurance funds will serve as the main source of healthcare funding, providing transparency and control over cash flow within the system.

Market Entry

Companies attempting to enter the Russian market need to be willing and able to do the following:

  • Commit time, personnel, and capital, as developing business in Russia can be resource-intensive.
  • Conduct market research, such as with the U.S. Commercial Service’s Gold Key or International Partner Search services to help identify opportunities and potential Russian business partners.
  • Conduct due diligence, with actions and programs like the U.S. Commercial Service’s International Company Profile service to ascertain the reliability of business partners.
  • Consult with U.S. companies already present in the market, as well as with the U.S. Commercial Service and business organizations such as the American Chamber of Commerce in Russia and the U.S.- Russia Business Council.
  • Communicate regularly with Russian business partners to ensure common understanding of expectations.
  • Frequent travel to Russia is strongly recommended in order to establish and maintain relationships with partners, build rapport, and to keep abreast of changing market conditions.
  • Maintain a long-term thought process to implement solid laid plans and achieve positive results.

Current Market Trends

The Russian medical devices market is very attractive for U.S. companies. The market is one of the largest in central and eastern Europe. It still heavily relies on imported medical devices, despite Russian government efforts to develop a strong and robust medical technology industry. Public medical facilities prefer to buy medical devices from foreign manufacturers if they have the choice. In February 2017, the Russian government extended the re-registration deadline for medical devices until 2021, which saved a lot of time, effort, and money for medical devices manufacturers already present on the Russian market.

Main Competitors

The 2016 market for imported medical devices was segmented as follows: diagnostic imaging: 19.4%, consumables: 15.2%, dental products: 8.9%, orthopedics & prosthetics: 8.6%, patient aids: 13%, and “other medical devices:” 35%. Industry experts generally foresee growth in medical device imports in the coming years.

Germany, the United States and China are Russia’s leading suppliers. Principal U.S. exports include high-tech medical products, diagnostic imaging, orthopedics and prosthetics. Chinese exports consisted mostly of bandages and dressings, and therapeutic appliances. The following American medical device manufacturers are among those present in the Russian market: J&J, GE Healthcare, Medtronic, Varian, Baxter, and Stryker. Among the leading European manufacturers present in Russia are Philips and Siemens.

Current Demand

The Russian market for medical devices has potential for growth because of an aging population. As a result of the Russian National Project “Health,” that took place from 2005 to 2011, over 10,000 municipal polyclinics received new high-tech medical equipment. This equipment needs servicing, spare parts and disposables, so it is a good opportunity for U.S. companies to supply these products and services.

Opportunities also exist beyond in the main cities of Moscow and St. Petersburg. As other Russian regions invest in new equipment and supplies, it is important for U.S. companies to explore these regions as well. The “Russian Strategy for the Development of Medical Science until 2025,” which was approved in 2013, also provides concrete opportunities for U.S. companies.

Registration Process

  • Registration certificate for medical devices
    Toxicology, technical, electrical and Electromagnetic Compatibility (EMC) tests must be carried out on medical devices. Manufacturers have to send samples to Russian accredited test laboratories for these assessments. Then manufacturers or their authorised representative send a technical dossier, that consists of product description and test results to Roszdravnodzor (the main regulatory body for medical devices), which can decide if any clinical testing will be necessary. The Ethics Committee of the Russian Ministry of Health have to issue approvals for these clinical trials. If the clinical trials were successful, then Roszdravnodzor will issue a registration certificate with unlimited validity and record the device in the national register of medical devices.

  • Declaration of conformity
    The declaration of conformity can only be issued to companies legally registered in Russia. This document confirms that the medical device complies with all technical requirements and standards.

In addition, the five countries of the Eurasian Economic Union (EAEU) are moving toward the common market for medical devices. This process was started back in January 2016 and should be completed by January 2021, when manufacturers will have a choice to have one marketing authorization – registration certificate for all five member countries.


The government Decree No. 968, issued in September 2014, aims to increase transparency in the medical device reimbursement system and determines the procedure for developing medical device reimbursement lists. The legislation focuses on implantable devices and medical aids. The reimbursement list contains brand names of medical devices that are to be compensated from public sources and will be updated at least once every two years.

Companies are supposed to submit clinical data, a health economic evaluation, results of safety inspections, and data regarding the volume of the manufactured/imported product. Then the special commission, which will include representatives from various Russian ministries and government agencies, reviews these document and make a decision to include the products into the list.


The most important market barriers are the following:

  • Limited capacity of the regional budgets to finance expenditures on fixed assets for medical health facilities.
  • The Russian Ministry of Industry and Trade of the Russian Federation approved on the 2nd April 2015, a strategic 5-year plan for import substitution in the pharmaceutical and medical device industry. Within this plan, there is a list of 111 groups of medical devices detailing targeted market shares of foreign manufacturers by 2020. Among them, for example, are surgical disposable materials (target is 40% imports in 2020, compared to 90% at the moment), prostheses, endoprostheses and their parts, cardio pacemakers (10% import in 2020 vs. 85% now), endoscopes (35% vs. 100%), X-ray equipment, and other groups of medical devices.

Procurement & Tenders

The regional authorities are responsible for procuring medical devices for hospitals, scientific research institutes and polyclinics. Local authorities in partnership with their medical establishments are now responsible for identifying their requirements, drawing up the procurement list for the necessary equipment, inviting tenders and awarding contracts. The procurement of medical devices under national government schemes is paid for with government funding and the regional authorities have to contribute a certain percentage of the contract value.

Trade Events

Moscow International Optical Fair (MIOF)
September 11-13, 2018

Dental Expo

September 24-27, 2018

International exhibition of equipment for non-destructive testing and technical diagnostics (NDT)

October 23-25, 2018

International exhibition of testing and measuring equipment, testing and control

October 23-25, 2018

Zdravookhraneniye, International Exhibition for Health Care, Medical Engineering and Pharmaceuticals

December 3-7, 2018

Laboratory Diagnostics

March, 2019

Local Associations

IMEDA (International Medical Device Manufacturers Association):

U.S. Commercial Service Contact Information

Name: Yuliya Vinogradova

Position: Commercial Specialist


Phone: +7 495 728 54 05

Best Prospects

In February 2015, Russia barred foreign medical device manufacturers from participating in government tenders for a specific list of medical devices (mostly low-technology goods) if two producers from an EAEU Member State participated in the tender. In December 2016, the Russian government expanded the list of covered goods to include 86 additional products (such as gauze and cotton dressings, glucometers, defibrillators, and certain types of tomography scanners). Despite this preference, there are still opportunities for U.S. suppliers where EAEU analogs do not exist. These devices usually use innovative technologies and require large investments in R&D, including diagnostics and visualization, cardiovascular, ophthalmology, orthopedics, laboratory diagnostics, and urology equipment.

Statistics Snapshot

Market Size

Healthcare spending (including investment)


... as percent of GDP


Hospitals, Procedures, Healthcare Professionals

Number of hospitals

5,457 (2016)


5,100 (2016)


357 (2016)

Number of hospital beds

1,226,514 (2016)


Number of surgical procedures

15,487.7 (2016)


708,641 (2016)


61,135 (2016)




Life expectancy men/women

total population: 70.8 years

male: 65 years

female: 76.8 years (2016 est.)

Infant mortality total:

6.9 deaths/1,000 live births

male: 7.7 deaths/1,000 live births

female: 6 deaths/1,000 live births (2016 est.)

Percent of population older than 65


Annual deaths

13.6/1,000 population (2016 est.)

...caused by [cardiovascular disease]

110.7/1,000 population

...caused by [cancer]

456,382 in 2012 and predicted 496,531 by 2035

Sources: BMI

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