Overview

(total market size = (total local production + imports) - exports)
Units: $ millions
Source: Fitch Solutions (former Business Monitor International)

The Russian medical device market is very attractive for U.S. companies and is one of the largest in central and eastern Europe. Despite the Russian Government’s efforts to develop a robust medical technology industry, public medical facilities prefer to buy medical devices from foreign manufacturers if they have the choice and means. In February 2017, the Russian government extended the re-registration deadline for medical devices until 2021, which averted the need for rushed re-registration efforts that would have cost much time, effort, and money for medical device manufacturers currently present on the Russian market.

In addition, the five countries of the Eurasian Economic Union (EAEU) are moving toward a common market for medical devices.  This process commenced in January 2016 and should be completed by January 2021, when manufacturers will have a choice to apply for solitary marketing authorization or a registration certificate valid for all EAEU five member-countries. The Eurasian Economic Union Commission, the main governing body of  EAEU publishes the most recent information about the registration process, notified bodies, and already registered medical devices.

Russia’s 2018 market for imported medical devices was segmented as follows: diagnostic imaging: 19.6%; consumables: 15%; dental products: 9.8%; orthopedics & prosthetics: 9.3%; patient aids: 14%; and “other medical devices:” 32.3%.  Industry experts generally foresee growth in medical device imports in the coming years.

Principal U.S. exports include high-tech medical products, diagnostic imaging, and 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.

Leading Sub-Sectors

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 at least two producers from EAEU member countries 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 R&D investments, including diagnostics and visualization, cardiovascular, ophthalmology, orthopedics, laboratory diagnostics, and urology equipment.

Opportunities

Russia’s aging population contributes to the medical device market’s growth potential.  As a result of the Russian national project “Health,” carried out from 2005 to 2011, over 10,000 municipal polyclinics received new high-tech medical equipment. This equipment needs servicing, spare parts, and disposables, providing an opportunity for U.S. companies to supply these products and services.

During President Putin’s May 7, 2018, inaugural address, he spoke about healthcare issues and his comments were reflected in the decree, “On the National Goals and Strategic Objectives of the Development of the Russian Federation through 2024.”  As part of this initiative, Russia is undertaking efforts to enhance systems for early disease detection and distance monitoring.  The main areas of focus are cancer, cardiovascular, and pediatrics; the anticipated total healthcare investments for the next six years will be approximately $160 billion.

Opportunities for U.S. medical device producers exist not only in Moscow and St. Petersburg but also in Russia’s other regions. The “Russian Strategy for the Development of Medical Science until 2025,” which was approved in 2013, indicates concrete opportunities for U.S. companies that can provide scientific equipment for use in research and development.

Because of the pandemic, the Russian government signed Resolution No. 233  (http://government.ru/docs/39057/)on March 2, 2020, which temporarily banned the export of 16 types of medical devices including face and surgical masks, respirators, protective glasses, and clothes.  Though this ban was supposed to last until June 1, 2020, it was lifted on April 30, 2020, a really good indicator for potential investment by U.S. companies.

In addition, the Russian government adopted Resolution No. 299 (http://publication.pravo.gov.ru/Document/View/0001202003190036) on March 18, 2020, which made state registration much simpler and faster (5 days) for  36 types of low-risk protective medical devices, including surgical and protective face masks, respirators, medical protective clothes, surgical suits, medical gloves, etc.

On April 3, 2020, another simplified registration procedure (6 days) for medical devices and IVDs intended to diagnose and treat COVID-19 was established by the Russian government in Resolution No. 430 (http://publication.pravo.gov.ru/Document/View/0001202004060033).  In addition, there was a list of some medical devices and IVDs that could be imported without registration until December 31, 2020.

Trade Events

Moscow International Optical Fair (MIOF)
Moscow

Russian Congress of Laboratory Medicine
Moscow

International exhibition of testing and measuring equipment, testing and control
Moscow

Zdravookhaneniye
Moscow

Analitika Expo
April 19-22, 2022
Moscow

Resources

• Federal Service for Surveillance in Healthcare (Roszdravnadzor)
• International Medical Device Manufacturers Association (IMEDA)
• Dentons
• Remedium
• Vademecum
• Fitch Solutions (former Business Monitor International)