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Healthcare Resource Guide: Russia

Russia Statistics

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement

Barriers

Procurement & Tenders

Trade Events

CS Contacts

Best Prospects

Market Size

Capital: Moscow

Population: 143,439,831

GDP*: $12,736 (2014)

Currency: Russian ruble

Language Russian

Summary

Russia’s healthcare system is evolving rapidly and this is creating many promising areas for U.S. medical equipment exports. It is currently estimated that only 20% of the Russian population of 143 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) health care 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. First, the size of the market is one of the largest in the Central & Eastern Europe. It still heavily relies on imported medical devices, despite all the efforts of the Russian government to develop a strong and robust medical technology industry. The 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 all the medical devices manufacturers present on the Russian market.

Main Competitors

In 2015, the structure of the imported medical devices market was the following: 22.5%, diagnostic imaging; 15.4%, consumables; 8.8%, dental products; 7.7%, orthopedics & prosthetics; 12.9%, patient aids; and 32.9%, other medical devices. In 2016, in dollar terms, imports decreased or stayed the same, but in Russian rubles the import market increased. Industry experts envision the positive dynamics of imported medical products even in U.S. dollars in the next couple of years.

Germany, the U.S. and China are the leading suppliers in Russia. The main U.S. export products are high technology medical products, diagnostic imaging and orthopedics and prosthetics. Chinese exports consisted mostly of bandages and dressings, and therapeutic appliances.

The following foreign medical device manufacturers are present in the Russian market: B. Braun, BD, Fresenius Medical Care, J&J, Medtronic, Philips, Siemens, Stryker, GE Healthcare and many others.

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 technology 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.

After a couple of years of economic recession, industry experts see potential for a recovery in the next two years, which means that medical institutions, especially in the private sector will be more willing and capable to buy new medical equipment, devices and disposables.

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.

Reimbursement

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.

Barriers

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

Since 2008, 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

Zdravookhranenie, International Exhibition of Medical Equipment and Drugs

December 4-8, 2017

Moscow

www.zdravo-expo.ru/en


Local Associations

IMEDA (International Medical Device Manufacturers Association)
http://en.imeda.ru/

U.S. Commercial Service Contact Information

Name: Yuliya Vinogradova

Position: Commercial Specialist

Email: yuliya.vinogradova@trade.gov

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 because there are few EAEU producers. The best opportunities are in devices that with innovative technologies and require large investments in Research & Development, including diagnostics and visualization, cardiovascular, ophthalmology, orthopedics, laboratory diagnostics, and urology equipment.

Market Size

Healthcare spending (including investment)

 

... as percent of GDP

6.31% of GDP (2016)

Hospitals, Procedures, Healthcare Professionals

Number of hospitals

5,100 (2016)

…Public

5,100 (2016)

…Private

357 (2016)

Number of hospital beds

1,226,514 (2016)

...of which in specialized clinics and rehabilitation centers N/A

 

Number of surgical procedures

15,487.7 (2016)

Physicians

708,641 (2016)

Dentists

61,135 (2016)

Demographics

Population

 

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

18.6

Annual deaths

13.6 deaths/1,000 population (2016 est.)

...caused by [cardiovascular disease]

110.7 DAYs per 1,000 BMI

...caused by [cancer]

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


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