RF Government Resolution No. 102 of February 5, 2015 approved a list of certain types of foreign-manufactured medical devices (the “List” and “Devices,” respectively) in the procurement of which state and municipal customers are obligated to reject bids for the supply of Devices manufactured in countries that are not members of the Eurasian Economic Union (“EAEU”), if at least two bids to supply the Devices originating from EAEU member states are received (i.e., the “third one is out” rule).

RF Government Resolution No. 337 of April 22, 2016 on Amendments to Russian Federation Government Resolution No. 102 of February 5, 2015 (enters into force on May 4, 2016) has made certain clarifications to the procedure for applying these restrictions. The following, inter alia, are provided for the following:

  • in order to apply the restriction it is necessary that (а) at least two bids be filed to supply Devices manufactured only in the EAEU, and (b) the Devices in the bids be manufactured by different manufacturers that are not in the same group according to the criteria of Federal Law No. 135-FZ on Protection of Competition of July 26, 2006 (the bold text is new);
  • bids containing offers to supply foreign Devices and that are not rejected according to the “third one is out” rule must otherwise meet the conditions of admitting bids for procurement of foreign products established earlier by the Ministry of Economic Development of the Russian Federation1;
  • for the purposes of restricting admission of Devices originating from foreign states, it is not permitted to simultaneously include in the same contract (the same lot) both Devices on the List and those not on the List;
  • if when the contract was executed the foreign manufacturer’s bids were rejected in accordance with the “third one is out” rule, then later, in the course of performing that contract, it is not permitted to substitute a Device manufactured in the EAEU and specified in the winning bid and the relevant contract with a Device whose country of origin is not an EAEU member state. Similarly, it is not permitted to substitute the manufacturer of such Device specified in the winning bid and contract with a different manufacturer.

The List of Devices itself has not undergone any changes in terms of its composition; however, Device codes according to the Russian National Product Classifier by Types of Economic Activity (OKPD2) OK 034-2014 have been added to the Device codes previously indicated in the List according to the Russian National Product Classifier by Types of Economic Activity (OKPD) OK 034-2007.