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Medical devices destined for the Russian market must meet both national and regional regulations. This means demonstrating compliance both to Law 323 of the Russian Federation and the relevant Customs Union Technical Regulations (CU-TR).
 
Russia is an integral part of Eurasian Customs Union, which also includes Belarus and Kazakhstan. Medical devices are regulated by CU-TRs and must demonstrate compliance before they are imported and placed on the market. 

Russian regulations

At the present time, compulsory requirements for medical devices are included in each member country’s national legislation. In Russia, this is implemented as article 38 of law number 323 of the Russian Federation. The law includes definitions of medical devices, classifications, risk classes and methods of registration.

Preparations for a new law on the Safety of Medical Devices are currently ongoing. The new law will include requirements for manufacturing, sales, marketing and use of medical devices. It will also define the responsibilities of all parties involved in their manufacture and distribution.

Customs Union harmonization

At the Customs Union level, requirements for medical device safety, effectiveness and quality, is still a work in progress. Common requirements will cover, for example, toxicological, clinical and technical requirements, and testing. The intention is to harmonise requirements within the Customs Union with existing European requirements. How this will be realised is not defined at this stage.

Economic limitations

In February 2015, the Russian government published Act 102. This new legislation places limitations on how the Russian state and communities may purchase foreign medical devices. These limitations are part of the country’s economic crisis recovery plan and cover about 40 different product categories, including CT and X-ray devices, ECG and blood transfusion equipment. The full list (in Russian) (PDF 170 KB). 

For more information, please contact:

Nina Pihlman
Russian and Customs Union Certification
Operations Manager

SGS Finland
SGS Inspection Services Oy
Sarkiniementie 3 (P.O.Box 128)
FI-00210 Helsinki, Finland
t: +358 9 6963 666