Summary Market Entry Current Market Trends Main Competitors Gov. Tenders FAQ
Current Demand Registration Process Barriers Trade Events Gov. Health Plans CS Contact
Capital: Moscow Population: 143 million GDP*: 1.86 Trillion US$ Currency: Russian ruble Language: Russian
Summary
The Russian medical equipment and supply market is one of the fastest growing sectors of the economy. There is an unsatisfied deferred demand for medical equipment across the country. The Russian Government is the largest provider of medical care through a national healthcare system, and hence decides which medical equipment to buy for the country. This fact shapes the demand for medical technology and products.
Russian Health Sector Overview PowerPoint (Nov. 2014)
Market Entry
Companies attempting to enter the Russian market will need to be willing and able to do the following:
Current Market Trends
Russia instituted a comprehensive reform of its healthcare system, and healthcare is “Priority #1” among the government’s national priority projects. Russia’s healthcare system is rapidly evolving, which is creating many promising areas for U.S. medical equipment exports. It is currently estimated that only 20% of the Russian population of 142 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 the patients’ pockets. Voluntary healthcare insurance programs account for approximately one-third of total private healthcare expenditures. According to long-term reform plans, mandatory insurance funds will serve as the main source of healthcare funding and should provide transparency and control over cash flow within the system.
According to “Healthcare through 2020”, a document developed by the Ministry of Healthcare and Social Development, Russian citizens will begin to receive higher quality medical care which will be standardized throughout Russia. It states that there will be new and effective medical procedures introduced and that new medical equipment will be supplied to institutions. However, there are significant downward pressures on the Russian government budgets and it remains to be seen whether these goals will be reached. Russia has joined the WTO, which should lower tariffs for medical equipment from the present 15% to between 0 and 7%.
USD in millions
2012
2013
2014 est.
Total Market Size
3,800,000
4,060,000
4,200,000
Total Local Production
620,000
700,000
800,000
Total Exports
140,000
170,000
220,000
Total Imports
3,320,000
3,530,000
3,620,000
Imports from the U.S.
200,000
300,000
400,000
The chart above shows the evolution of the Russian medical equipment market, including the share of local production and imports from the United States (estimated at $400 million).
Currently, almost two-thirds of the medical equipment and devices being used in public clinics and hospitals are obsolete and need replacement. There are two major issues that the Russian healthcare system faces; Healthcare facilities are in very poor condition. According to data from the Russian Federal Statistic Service, 2% of medical facilities are in hazardous condition, 8.5% do not have cold and hot water, 32.5% do not have hot water, more than 10% do not have central heating, 11.2% do not have a sewage system, and 6.7% do not have telephone connections. In order to solve these problems, the regional parts of the budgets allocated for modernization will be used. Secondly, new medical equipment terribly needed for those medical facilities to be brought up to par – a positive factor is that this will drive the demand for medical equipment.
The Russian Government is aggressively seeking to increase the amount of medical equipment manufactured by Russian producers. Specifically, foreign manufacturers of medical equipment currently selling to the Russian Government are strongly encouraged to “localize” production for medical devices and pharmaceuticals. If a company fails to demonstrate a sufficient percentage of local content, it may be disadvantaged in Russian Government tenders or disqualified altogether. Previously, the Russian Government had accepted packaging of products in Russia as meeting a minimal requirement for local content. However, that understanding will expire in 2015 after which the GoR will require more substantial investment in manufacturing or research and development. Foreign medical device and pharmaceutical companies have expressed that meeting these requirements will be highly disruptive, challenging, and perhaps not commercially viable.
Russian Government organizations are the main users of medical equipment; approximately 80% of medical equipment is sold to them. Private hospitals and patients represent the other 20%. Because of that uneven distribution, Government procurement programs (“tenders”) play a crucial role in this market but are difficult to gain access to bid on them.
Main Competitors
According to various sources, imported medical devices constitute 60% of the Russian market. Statistical data show that 40-45% of imports come from Germany, 20-25% from the United States, 10% from Japan, and 5% each from Italy and France. For the last three years, a growing number of cheap analogs from China and Pakistan have entered the Russian market in large volumes.
Current Demand
Russia is still dependent on imports for a significant number of medical equipment industry sub-sectors, especially those requiring large investments in research and development (R&D), innovative technologies, and automation. The most promising market segments include diagnostics and visualization, cardiovascular, ophthalmology, orthopedics, laboratory diagnostics, and urology equipment and technology
Registration Process
All medical equipment manufactured in Russia or abroad needs to be registered and certified in order to pass through customs, be sold, and used in Russia. The following documents will be needed.
Registration Certificate: Is issued by the Federal Service of Health Care and Social Development Control and is valid indefinitely.
ROLE: Act as permission for the product to be introduced to the market. Establishes the OKP code (Russian product classification system), in accordance with which the VAT rate is determined for customs clearance of the product - either 0% or 10% (the standard VAT rate is 18%);
Companies should treat seriously threats to Intellectual Property and take steps to protect their IPR. Existing Russian legislation, when adequate, is not enforced effectively or consistently.
Before starting the process of registration, a manufacturer of medical equipment should keep in mind that the process itself is costly and complicated since the regulatory procedures continuously change and are written only in Russian. It is highly recommended that U.S. companies work through a qualified Russian representative, subsidiary, Russian distributor, or a specialized consulting company to navigate this difficult process.
Barriers
Despite positive changes in the last several years, the medical standards regime in Russia still lacks transparency. FDA approval is not accepted here and Russia continues to rely on product testing as a key element of the product approval process. Other types of product safety assurance, such as plant auditing, quality systems, and post market vigilance are still underdeveloped. Russia continues to follow redundant practices for the testing of internationally accepted certified products, which can delay the entry of products into the country. Problems with customs can also be a factor here.
Trade Events
Zdravookhranenie
December 08-12, 2014 Moscow http://www.zdravo-expo.ru
Government Tenders
Government Health Plans
U.S. Commercial Service Contact Information
Name: Misha Minkevitch Position: Commercial Specialist Email: misha.minkevitch@trade.gov Phone: +7 812 326 2582
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