Medical Registration Certificate

WWBridge overview of main requirements, applied products, procedures and timing to get the Roszdravnadzor approval for medical devices.


Medical Registration Certificate

Although, not long ago Eurasian Economic Union (EAEU) approved the medical registration requirements for all Customs union countries (Belarus, Kazakhstan. Russia, Armenia and Kyrgizia) that will come into force in 2021. Since 2021 all medical devices should be approved in the EAEU system. There are inquiry letters from CU members to prolong this date for 10 years. Track the news on this matter to be informed.

Anyway until the EAEU is not obligatory the MD manufacturers should take into consideration the set of laws that regulate the registration process of MD in the Russian Federation. Among them are the following main legal acts:

  • Federal Law No. 323-ФЗ “On the Principles of the Protection of Citizens' Health in the Russian Federation” dated November 21, 2011
  • Federal Law of No. 162-FZ “On Standardization in the Russian Federation” dated June 29, 2015
  • Federal Law No. 184-ФЗ “On Technical Regulation” dated December 27, 2002
  • Decree of the Government of the Russian Federation No. 1416 “On approval of the rules for state registration of medical devices” dated December 27, 2012
  • Decree of the Government of the Russian Federation No. 633 “On Amendments to the Rules for Registration of Medical Products” dated May 31, 2018
  • Decision of the Ministry of Health of the Russian Federation No. 2n “On approval of the procedure for conducting conformity assessment of medical devices in the form of technical tests, toxicological tests, clinical trials for the purpose of state registration of medical devices” dated January 9, 2014

According to the Russian legislation, there are the following risk classes of MD:

  • class 1 - medical products with low individual risk and low risk for public health;
  • class 2a - medical products with middle individual risk and/or low risk for public health;
  • class 2b - medical products with a high individual risk and/or middle risk for public health;
  • class 3 - medical products with high individual risk and/or high risk for public health.

The same classes correspond to in-vitro devices that is also need to be Registered as MD.
To initiate the MD certification you need first to find the partner (distributor or any other company – resident of the Russian Federation) which will apply for certification of the product and track all test.

There 3 main test group:

  • toxicology tests;
  • technical tests;
  • clinical trials.

The Applicant is also responsible for all customs clearance procedures on the stage of importing the samples. WorldWideBridge LLC can act as a Local representative of the manufacturer that gives the opportunity to distribute the product through a wide range of selling companies so having more flexibility.

Taking into consideration the fact that any foreign test reports don't exclude the local testing you should mind that the process will last for 8-12 months.

Also, there are strong requirements for 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 backup. 

We can start from the inquiry to [email protected] Please describe in details the product you want to apply with. We will be pleased to help you.

Certification experts in Russia will be pleased to consult you in your own language

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