Regulatory Changes and Market Access for Medical Devices in Russia

Emerging markets present medical device manufacturers with a unique opportunity for growth. Many of these markets are focused on manufacturing as a way to drive economic growth. Increasing populations and healthcare reform are also driving demand for medical services and supplies. One such country with a rapidly expanding medical device market is Russia.

Between 2012 and 2014, medical device imports from the United States to Russia were estimated to have doubled from $200 million to $400 million. There is room for additional growth in this market, as statistics show that the United States accounts for 20–25% of Russia’s medical device imports. According to various U.S. government reports, the most promising sectors include diagnostics, cardiovascular, ophthalmology, orthopedics and urology.1

While offering great opportunity for many manufacturers, Russia has its own regulatory system that must be considered. This system has undergone changes in recent months, meaning that medical device manufacturers and exporters need to be aware of multiple factors at play if they desire to enter this market. Beyond obtaining FDA approval and maintaining compliance to U.S. standards and certifications, there are several key considerations for trade in the emerging Russian market.

Russia, along with Belarus and Kazakhstan, founded the Eurasian Customs Union in 2010. It has since been incorporated into the Eurasian Economic Union (EEU) and expanded to include Armenia and Kyrgyzstan. The purpose of the Customs Union, and now the EEU, is to create economic efficiency and promote free trade of goods between its members. As a concept similar to European Economic Area, the Customs Union recently rolled out its own mark, similar to the CE mark, called the EAC mark, which went into effect in March of this year.

The EAC mark may present some challenges for manufacturers interested in entering Russia, as it is likely they have been using the GOST standards, put in place by the Soviet Union and continued in use by the Commonwealth of Independent States. However, GOST is being replaced by EAC in most cases, so it is important to understand the process for registration and certification to EAC when entering the Russian market.

In Russia medical device registration must be completed prior to any certifications, such as EAC marking. Registration is completed through Roszdravnadzor, Russia’s equivalent to the FDA. Also referred to as the Federal Service (FS), this department of the country’s Ministry of Health requires a manufacturer to prepare a dossier for imported medical devices using FDA files. This registration covers safety requirements for the device.

If applicable, radio and electromagnetic compatibility (EMC) requirements may also apply. Radio requirements for Russia include RF certification from the Federal Agency of Communications (FAC) and Federal Security Service (FSS) notification, if the device uses encryption. EMC requirements include review by Roszdravnadzor/Ministry of Health/FS, radio certification (if applicable) and compliance with the old GOST-R standard. Some agents also require a CU EAC Declaration of Conformity (DoC) for customs clearance. As such, it is highly recommended that a medical device receive both a GOST-R DoC and a CU EAC DoC.

EMC testing conducted in chambers — Under the new EAC-mark requirements in Russia, EMC testing—conducted in chambers like the one seen here—may be required of devices it order to illustrate compliance with the previous GOST-R standard, which remains unchanged under the new mark’s standard.

In addition to a dossier, manufacturers are also required to compile a risk management file (RMF). The RMF should contain context around the risk management process as well as information on identified risks for a product. In addition to identifying the risks, each must be fully assessed, and guidelines and recommendations for mitigating risks should be outlined. Manufacturers must also be able to illustrate a monitoring system is in place to ensure continued assessment and mitigation.

To ensure technical accuracy, the RMF and dossier will need to be translated in Russian by a “responsible body”. Responsible bodies are accredited by Russia’s Federal Service for Accreditation (ROSACCREDITACIA). The paperwork, along with information related to factory inspections for any facilities in the country conducted in line with ISO 13485 or ISO 9001, will be submitted to the Ministry of Health, where it will reviewed in a manner similar to the USA 510(k) review process. Samples may be required at the discretion of the Ministry.

Once an application is approved, the device is reviewed for clinical evaluations. Based on similar products already on the market, evaluations target the best doctors and hospitals. All clinical trial data must be submitted before a product can be fully approved by the government. It may take anywhere from eight months (if similar products are on the market) to a year or more for new products to the market.

During the review period, the certification body has two objectives: 1) to find faults and errors in the documentation and applications and 2) to certify the equipment for use. To that end, manufacturers must be prepared to make corrections to all documentation and the application. Forms or regulations may change, making corrections necessary. Photos and other data may be required to supplement the corrections. It is also important to be prepared for incomplete or erroneous clinical trial data and have a plan to address such issues, should they arise. If any such issues do occur, it will be necessary to resubmit documentation and applications, including fees.

These considerations, coupled with the changes underway in Russia, make entering the market seem both desirable and daunting for many medical device manufacturers. The following are some best practices that manufacturers can employ to better navigate these changing waters and help ensure success.

Increasing populations and healthcare reform are driving demand for medical services and supplies in Russia.
Get familiar with the EAC Mark and its related requirements. In Russia, the certification needs for this mark are similar to those of GOST; however, it is important to understand the differences, as the EAC Mark is replacing GOST. Additionally, it is also key to be aware of the differing requirements between Russia and the other members of the Customs Union. In short, certification in Russia will entail utilizing the EAC Mark and its criteria, while also meeting Russia’s specific standards and legal requirements.
Identify local representation. Like many markets, Russia requires in-country representation of any manufacturer looking to bring products into the country. This could include: a company-owned manufacturing or sale site within a country’s borders, a distributor operating in a country, or an in-country paper holding agency. Additionally, be prepared to confirm that any local suppliers and/or distributors meet inspection requirements and know how to coordinate any follow-up inspections, should the need arise.
Prepare your documentation. This includes your application, dossier, labeling, clinical trial test results, user manual and FDA filings. All paperwork must be translated by an organization approved by the Russian government, so it will be important to do the legwork to identify an approved translation resource.
Test your device. Depending on the device, this may include EMC evaluations and radio frequency, in addition to testing/certification to EAC mark standards. Consider using a third-party to conduct testing in line with Russia’s requirements.
Prepare for clinical trials. This may take up to a year, and follow-up trials may be needed if there are any issues with the data being collected or if Roszdravnadzor requires additional information or data.

Entering the Russian market presents many opportunities and challenges for medical device manufacturers. New regulations and the introduction of the EAC mark, mean a new process and certification considerations for the region. However, the reward of entering a market poised for growth may outweigh the risks.