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:
- 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”).
- 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. - 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.
- 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.