The Decree of the Government of the Russian Federation No. 337
dated 22 April 2016 amended the Decree of the Government No. 102,
dated 5 February 2015 by clarifying the procedure for applying the
restrictions on admission of certain types of medical devices
originating from foreign states to participation in procurements
for state and municipal needs (hereinafter –
Under the amended Decree No. 102, in the course of procurement
of certain medical devices manufactured outside Russia, the
customer shall reject all applications (final bids) with offers to
supply medical devices manufactured in foreign states
(other than the member-states of the Eurasian Economic
Union (EAEU)), provided that at least two applications
have been submitted meeting the requirements of the procurement
notice and (or) tender documentation (final bids), which
contain offers to supply one or
several types of medical devices included in the List and
manufactured in any of the EAEU member-states;
do not contain offers to supply the
same medical device from the same manufacturer or
manufacturers of the same group of persons, as defined in Article 9
of the Federal Law 'On Protection of
The amendments also provide that:
if an application (final bid)
containing an offer to supply certain medical devices included in
the list and manufactured in foreign states (save for the EAEU
member-states) (the List) is not be rejected the access conditions
shall apply for the purposes of procurement of goods manufactured
in a foreign state or a group of foreign states, established by the
Ministry of economic development of the Russian Federation;
medical devices included into the
List and medical devices not included therein may not be a subject
of the came contract (same lot);
if at the conclusion of a contract
the applications containing offers to supply certain medical
devices included in the list (save for the EAEU member-states) were
rejected in accordance with the restrictions, in the course of the
contract performance the replacement of a medical device with a
medical device originating not from the EAEU member-state as well
as the replacement of the medical device manufacturer shall be not
The list of certain medical devices originating from foreign
states, which are subject to the access restrictions for
procurement purposes, remained unchanged, however, was supplemented
with the codes in accordance with the All-Russian Classification of
Products by Economic Activities (OKPD2) OK 034-2014.
The restrictions on access to participate in procurement of
foreign medical devices (save for those originating from the EAEU
member-states) were introduced by the Government of the Russian
Federation within the powers in accordance with the Federal Law
'On the Contractual System for Procurement of Goods, Works and
Services for State and Municipal Needs' for the purposes of
protection of the internal Russian market and support of Russian
The amendments introduced by the Decree No. 337 became effective
on 4 May 2016.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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