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Recently, the Eurasian Economic Union (EAEU) approved the medical registration requirements for all Customs union countries (Belarus, Kazakhstan. Russia, Armenia and Kyrgyzstan) that will come into force in 2021. From 2021 all medical devices should be approved in the EAEU system.
As long as the EAEU is not obligatory, the MD manufacturers should take act within the framework of the laws that regulate the registration process of MD in the Russian Federation.
According to the Russian legislation, there are the following risk classes of MD:
The same classes apply to in-vitro devices which also need to be Registered as MD.
To initiate the MD certification you need a partner (distributor or any other company – resident company of the Russian Federation) which will apply for certification of the product and co-ordinate the testing.
There are 3 main test groups:
The Russian partner company is also responsible for all customs clearance procedures on the stage of importing the samples. NH Consulting can act as your local, Russian representative.
Considering the fact that foreign test reports have little value in Russia, you always have to arrange for testing in Russia. This process can take from 8 to 12 months.
In addition, there are strict requirements regarding the technical documentation that must be made in accordance with Russian laws. Our specialists will lead you through all stages providing detailed consultation and continuous support.
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