Decree of the Russian Government dated 5 February 2015 No 102
"On Restricting the Access of Certain Types of Medical Devices Originating from Foreign Countries for the purposes of Procurement for State and Municipal Needs"

Pursuant to Part 3, Article 14 of the Federal Law On the Contracting System in the Field of Procurement of Goods, Work, and Services for State and Municipal Needs, the Government of the Russian Federation r e s o l v e s:

  1. To approve the enclosed List of Individual Types of Medical Devices Originating from Foreign Countries Subject to Market Entry Restrictions in the Context of Procurement for State and Municipal Needs (hereinafter referred to as “the List”).
  2. To establish that, when procuring individual types of medical devices included in the List, the buyer shall reject all offers to supply medical devices originating from foreign countries, other than the Republic of Armenia, the Republic of Belarus, or the Republic of Kazakhstan, provided that at least two bids satisfying the requirements of procurement documentation have been submitted for the supplier selection process, which meet all of the following requirements:
    contain offers to supply one or several types of medical devices included in the List, which originate from 2 2560943 the Russian Federation, the Republic of Armenia, the Republic of Belarus, or the Republic of Kazakhstan;
    do not contain offers to supply one and the same type of medical device from one manufacturer.
  3. Proof of the country of origin of medical devices included in the List shall be a certificate of the origin of goods issued by an authorized agency (organization) of the Russian Federation, the Republic of Armenia, the Republic of Belarus, or the Republic of Kazakhstan in the format established by the Rules for Determining the Country of Origin of Goods, which make an integral part of the Agreement on the Rules for Determining the Country of Origin of Goods in the Commonwealth of Independent States of November 20, 2009, and in accordance with the criteria for determining the country of origin of goods specified in said Rules.
  4. The market entry restrictions for individual types of medical devices included in the List, which are established by this Resolution, shall not apply in the following cases:
    procurement notices for individual types of medical devices included in the List have been published in the unified procurement information system and/or invitations to participate in a non-public supplier selection process have been sent before the effective date of this Resolution;
    procurement of individual types of medical devices included in the List by diplomatic offices and consular institutions of the Russian Federation, trade missions of the Russian Federation, and official missions of the Russian Federation at international organizations, which perform such procurement for the purposes of supporting their own operations in the territory of a foreign country.
Prime Minister
of the Russian Federation
Dmitry Medvedev

LIST of Individual Types of Medical Devices Originating from Foreign Countries Subject to Market Entry Restrictions in the Context of Procurement for State and Municipal Needs (approved by the Decree of the Russian Government dated 5 February 2015 No 102)

Code per the All-Russia Product Classification by Type of Business (OKPD) OK 034-2007 Description of the type of medical device*
   
18.21.11.111
18.21.21.111
18.21.30.411
18.21.30.412
Medical outfits
24.41.60.330 Kits of reagents for detecting infectious agents by polymerase chain reaction method
24.41.60.363
24.41.60.364
Kits of reagents for quantitative and qualitative assay of immunoglobulins / antigens of infectious agents by immunoferment analysis method
24.41.60.384
24.41.60.391
Kits of reagents for quantitative and qualitative assay of hormones by immunoferment analysis method
24.41.60.395 Kits of biochemical reagents for assay of blood-coagulation factors
24.41.60.399 Kits of reagents for detecting infectious agents by polymerase chain reaction method
24.42.12.120
24.42.12.131
Alcohol antiseptic wipes
24.42.13.391 Kits (sets) of reagents for blood analyzers
24.42.23.110 Kits of reagents for blood typing and Rh factor determination
24.42.23.111 Kits of biochemical reagents for assay of ferments
24.42.23.111 Kits of biochemical reagents for assay of blood-coagulation factors
24.42.23.119 Kits of reagents for human blood phenotyping according to Rhesus, Kell, Kidd blood group systems
24.42.24.140
24.42.24.141
24.42.24.142
24.42.24.143
Special-purpose disposable sterile surgical products from non-woven materials for protection of patients and medical personnel
24.66.42.140 Selective and non-selective nutritive media
24.66.42.310 Kits of biochemical reagents for assay of substrates
24.66.42.341 Kits of biochemical reagents for assay of ferments
24.66.42.389 Kits (sets) of reagents for blood analyzers
25.22.14.210 Polymer containers for bio samples
29.23.13.331
29.23.13.335
29.23.13.990
Combined laboratory refrigerators;
pharmaceutical refrigerators;
medical freezers
33.10.11.111 Computer tomographic scanners with 1 to 64 slices
33.10.11.140 Single-photon emission computed tomography systems (gamma chambers)
33.10.11.112
33.10.11.113
X-ray diagnostic complexes with 2 workstations;
X-ray diagnostic complexes with 3 workstations;
X-ray diagnostic complexes based on a remotely controlled tripod table;
fluorographs;
mammographs;
mobile X-ray machines for use inside wards
33.10.12.111 Electrocardiographs
33.10.12.126 Bedside cardiac monitors;
daily ECG monitoring complexes
33.10.12.126 Glucose analyzers
33.10.13.119 Root canal needles
33.10.15.110 Dental air micromotors for handpieces;
handpieces for micromotors;
turbine dental handpieces
33.10.15.120 Surgical needles
33.10.15.121 Reusable and disposable medical injection syringes, with or without injection needles
33.10.15.134 Micro surgery scissors
33.10.15.136 Hard-alloy dental burs
33.10.15.152 Micro surgery forceps
33.10.15.154 Micro surgery needle holders
33.10.15.213 Micro surgery instruments for ophthalmology
33.10.15.430 Device for transfusion of blood, blood substitutes, and infusion solutions, including devices with a micro filter
33.10.15.610 Containers for collecting, storing, and transporting blood;
devices with a leukocyte filter;
devices for infusion of blood substitutes and infusion solutions
33.10.15.614 Polymeric gynecological Cusco vaginal specula;
disposable sterile gynecology inspection kits
33.10.16.150 Medical outfits
33.10.17.415 Osteosynthesis implants
33.10.18.110 Individual hearing aids
33.20.53.145 Devices for electrophoresis of blood serum proteins on cellulose acetate films
33.20.53.310 Blood clotting analyzers
33.20.53.311 Bilirubin analyzers; urine protein analyzers; semi-automatic biochemical analyzers
33.20.53.311 Hemoglobinometers
33.20.53.320 Individual blood glucose meters
33.20.53.332 Detecting amplifiers for real-time polymerase chain reaction assays

* In applying this List, one shall be guided both by the code per the All-Russia Product Classification by Type of Business (OKPD) OK 034-2007 and the name of the type of medical device corresponding to the specified code.