RUSSIAN FEDERATION GOVERNMENT DECREE dated 5 February 2015 No. 102.

«ON THE RESTRICTIONS AND CONDITIONS FOR ADMISSION OF CERTAIN TYPES OF MEDICAL DEVICES ORIGINATING FROM FOREIGN COUNTRIES  FOR THE PURPOSE OF PROCUREMENT TO MEET THE PUBLIC AND MUNICIPAL DEMANDS» The List of Amending Documents (as revised by RF Government Decrees dated 02.06.2015 No. 528, dated 22.04.2016 No. 337, dated 30.11.2016 No. 1268).

Pursuant to Device 14 of Federal Law “On the Contracting Procurement of Goods, Works, Services to Meet the Public and Municipal Demands”, the Russian Federation Government decrees that:

(as revised by the RF Government Decree dated 22.04.2016 No. 337)

1. The attached list of certain types of medical devices originating from foreign countries, in which respect restrictions are set forth for admission to procurement to meet the public and municipal demands shall be approved (hereinafter, the list).

(as revised by the RF Government Decree dated 22.04.2016 No. 337)

2. It shall be set forth that for procurement of certain types of medical devices included in the list, the customer shall reject all bids (final offers), containing offers to supply certain types of medical devices included in the list and originating from foreign countries (with the exception of Eurasian Economic Union member-countries), provided that for participation in bidding, at least 2 compliant procurement notifications and (or) procurement bids (final offers) have been submitted, which simultaneously:

contain offers to supply certain types of medical devices included in the list, of which the countries of origin are Eurasian Economic Union member-countries;

do not contain offers to supply the same type of a medical device from one manufacturer or manufacturers belonging to one group of persons that matches the signs provided for by Device 9 of Federal Law “On the Protection on Competition”, when such bids (final offers) are compared.

(Cl. 2 as revised by the RF Government Decree dated 22.04.2016 No. 337)

2(1). If a bid (final offer) that contains an offer to supply certain types of medical devices included in the list and originating from foreign countries (with the exception of Eurasian Economic Union member-countries) is not rejected according to the restrictions set forth by this decree, the conditions for admission to procurement of goods originating from a foreign country or a group of foreign countries set forth by the Russian Federation Ministry for Economic Development shall apply.

(Cl. 2(1) has been consummated by the RF Government Decree dated 22.04.2016 N 337)

2(2). It shall be set forth that for the purpose of limiting admission of certain types of medical devices originating from foreign countries, medical devices included in the list and not included therein may not be the subject matter of one contract (one lot).

(Cl. 2(2) has been consummated by the RF Government Decree dated 22.04.2016 N 337)

3. The proof of the country of origin of medical devices included in the list is the certificate of origin of goods issued by an authorized agency (organization) of Eurasian Economic Union member-countries according to the form established by the Rules for Determining the Country of Origin of Goods, which are an integral part of the Agreement on the Rules for Determining the Country of Origin of Goods in the Commonwealth of Independent States dated 20 November 2009, and in accordance with the criteria of determining the country of origin of goods provided for by the said Rules.

(as revised by the RF Government Decree dated 22.04.2016 No. 337)

3(1). In performing a contract, which conclusion involved rejection, pursuant to the restrictions set forth by this decree, of bids (final offers) containing offers to supply certain medical devices included in the list and originating from foreign countries (with the exception of Eurasian Economic Union member-countries), replacement of a medical device with a medical device which country of origin is not a member-country of the Eurasian Economic Union and replacement of the manufacturer of a medical device are not allowed.

(Cl. 3(1) has been consummated by the RF Government Decree dated 22.04.2016 No. 337)

4. The restrictions for admission of certain types of medical devices included in the list which are set forth by this decree shall not apply in the following cases:

placement of notifications about procurement of certain types of medical devices included in the list in the integrated procurement information system and (or) invitations to closed bidding for determination of a supplier, made before the effective date of this decree;

procurement of certain types of medical devices included in the list by the customers mentioned in Device 75 Part 1 of Federal Law “On the Contracting Procurement of Goods, Works, Services to Meet the Public and Municipal Demands” on the territory of a foreign country to support their own activity on that territory.

(as revised by the RF Government Decree dated 22.04.2016 No. 337)

Chairman of the Government

of the Russian Federation

D.MEDVEDEV

Approved by

the Decree of the Russian Federation Government

dated 5 February 2015, No. 102

LIST OF CERTAIN TYPES OF MEDICAL DEVICES ORIGINATING FROM FOREIGN COUNTRIES, IN WHICH RESPECT RESTRICTIONS ARE SET FORTH FOR ADMISSION TO PROCUREMENT TO MEET THE PUBLIC AND MUNICIPAL DEMANDS

List of Amending Documents (as revised by the RF Government Decree dated 30.11.2016 No. 1268)

Code according to Russian Classification of Products by Economic Activity Types (OKPD) OK 034-2007	Code according to Russian Classification of Products by Economic Activity (OKPD2) OK 034-2014	Medical Device Type Name <*>
17.40.22.149	22.19.71.190	Anti-decubitus orthopedic pillows with shape-memory effect
18.21.11.111 18.21.21.111 18.21.30.411 18.21.30.412 33.10.16.150	14.12.11 14.12.21 14.12.30.131 14.12.30.132 14.12.30.160	Medical clothes
18.21.30.530	14.12.30.170	Special clothes for physical condition maintenance
21.22.12.350	17.22.12.130	Sanitary – absorbing underwear (diapers, pads)
24.20.14.190	20.20.14.000	Medical devices containing antiseptics and disinfectants
24.41.60.330 24.41.60.399	21.10.60.196	Kits of reagents for identification of infection agents by polymerase chain reaction
24.41.60.363 24.41.60.364	21.10.60.196	Kits of reagents for quantitative and qualitative enzyme immunoassay test of immunoglobulins or antigens of infection agent
24.41.60.384 24.41.60.391 24.66.42.341 24.66.42.342 24.66.42.344	20.59.52.199 21.10.60.196	Kits of reagents for neonatal screening in dry blood spots
24.41.60.384 24.41.60.391	21.10.60.196	Kits of reagents for enzyme immunoassay of hormones
24.41.60.395	21.10.60.196	Kits of biochemical reagents for determining blood-coagulation factors
24.42.13.391	21.20.10.139	Kits (sets) of reagents for hematological analyzers
24.42.23.110	21.20.23.111	Kits of reagents for determining blood types and Rhesus factor
24.42.23.111	21.20.23.111	Kits of biochemical reagents for determining enzymes; kits of biochemical reagents for determining blood-coagulation factors
24.42.23.119	21.20.23.111	Kits of reagents for human blood phenotyping by Rhesus, Kell and Kidd blood group systems
24.42.24.120	13.20.44.120	Gauze, medical, bleached, cotton
24.42.24.120 24.42.24.131	21.20.24.160	Napkins, antiseptic, alcohol; Gauze napkins, medical, sterile and non-sterile
24.42.24.120 24.42.24.139	21.20.24.150	Wits of gauze, medical, sterile and non-sterile; dressing packs, medical, sterile and non-sterile
24.42.24.127	21.20.24.131	Bandages, sterile and non-sterile, gauze
24.42.24.128 24.42.24.139	21.20.24.150	Tampons, setons, turundas, gauze swabs, sterile and non-sterile
24.42.24.139	21.20.24.160	Wound dressings and blankets impregnated or coated with medicines
24.42.24.140 24.42.24.141 24.42.24.142 24.42.24.143	14.19.32.120	Special surgical disposable sterile devices from nonwoven materials for patient’s and medical staff’s protection
24.42.24.149	21.20.24.150	Face masks, medical, sterile and non-sterile
24.66.42.140	20.59.52.140	Culture media, selective and non-selective
24.66.42.310	21.20.23.111	Kits of biochemical reagents for determination of substrates
24.66.42.341	20.59.52.199	Kits of biochemical reagents for determination of enzymes
24.66.42.389	20.59.52.199	Kits (sets) of reagents for hematological analyzers
25.22.14.210	22.22.14.000	Containers for biological samples, polymer
29.23.13.331 29.23.13.335 29.23.13.990	28.25.13.111 28.25.13.115 28.25.13.119	Refrigerators, combined laboratory; refrigerators, pharmaceutical; medical freezers
29.23.14.110 29.23.14.113	28.25.14.110	A clean-room equipment outfit; air filtering, decontamination, and (or) purification equipment and apparatuses
30.02.13.110 30.02.13.120 30.02.13.190 30.02.14.110 30.02.14.120 30.02.14.123 30.02.14.124 30.02.14.129	26.20.13.000 26.20.14.000	Radiological information systems for acquisition, processing, transmission, and archiving of digital medical images
31.50.34.190	27.40.39.110	Operating and examining medical lamps
33.10.11.111	26.60.11.111	Computer tomography scanners with 1 to 64 slices
33.10.11.112 33.10.11.113	26.60.11.112 26.60.11.113	X-ray diagnostic outfits for 2 working places; X-ray diagnostic outfits for 3 working places; X-ray diagnostic outfits on the base of a remote-control table; photofluorographic units; mammography machines; ward mobile x-ray apparatuses
33.10.11.113	26.60.11.113	X-ray apparatuses, mobile, surgical (С-arm)
33.10.11.140	26.60.11.120	Single-photon emission computed tomography systems (gamma-ray chambers)
33.10.12.110 33.10.12.119 33.10.12.125 33.10.15.320 33.10.15.329	26.60.11.113 26.60.12.110 26.60.12.129 32.50.1 32.50.21.112	Endoscopy outfits
33.10.12.111	26.60.12.111	Electrocardiographs
33.10.12.123	26.60.12.123	Instruments for investigation of acoustic vibrations in human organs
33.10.12.126	26.60.12.129	Bedside cardio monitors; 24-hrs. electrocardiography monitoring outfits; glucose analyzers
33.10.12.140	26.60.13	Irradiators, phototherapeutic, neonatal
33.10.13.119	32.50.11.000	Root needles
33.10.14.111	32.50.12.000	Steam sterilizers
33.10.15.110	32.50.13.190	Pneumatic micromotors for dental tips; tips for micromotors; dental turbine tips
33.10.15.120	32.50.13.110	Piercing instruments; surgical needles
33.10.15.121	32.50.13.110	Injection syringes, medical, reusable and disposable, with and without injection needles
33.10.15.130	32.50.13.190	Cutting and percussion instruments with a sharp (cutting) edge
33.10.15.134	32.50.13.190	Microsurgery scissors
33.10.15.136	32.50.13.190	Dental burs; dental diamond tips including shaped ones; dental hard-alloy drills
33.10.15.140	32.50.13.190	Pushing aside instruments
33.10.15.144	32.50.13.190	Pulp extractors
33.10.15.150	32.50.13.190	Multi-surface exposure instruments
33.10.15.152	32.50.13.190	Forceps, microsurgical
33.10.15.154	32.50.13.190	Needle holders, microsurgical
33.10.15.160	32.50.13.190	Probing, bougienage instruments
33.10.15.180	32.50.13.190	Root canal filling instruments; accessory instruments
33.10.15.190 33.10.15.513	32.50.1 32.50.13.190	Electrosurgical apparatuses
33.10.15.212	32.50.13.120	Slit lamps
33.10.15.213	32.50.13.120	Ophthalmic set of trial spectacle lenses; microsurgical instruments for ophthalmology
33.10.15.430	32.50.21.112	Equipment for transfusion of blood, blood substitutes, and infusion solutions, including those fitted with a microfilter
33.10.15.441	32.50.21.121	Inhalation narcosis apparatuses
33.10.15.512 33.10.15.619	26.60.13.190 32.50.13.190	Defibrillators
33.10.15.519 33.10.15.619	26.60.13.190 32.50.13.190	Neonatal heaters; neonatal tables with automatic neonate-warming temperature control
33.10.15.610	32.50.13.190	Containers for blood banking, storage, and transportation; equipment with a leukocyte filter; equipment for infusion of blood substitutes and infusion solutions
33.10.15.614	32.50.13.190	Urogenital probes; colposcopes; Cusco polymer gynecological mirrors; gynecological examination sets, disposable, sterile
33.10.15.619	32.50.13.190	Nasal respiratory support apparatuses for infants; infant intensive care incubators; climate-controlled medical modules (clean room)
33.10.15.619	32.99.59.000	Medical gases and power supply consoles
33.10.16.122	32.50.21.112	Therapeutic equipment (hydromassage baths and shower cubicles)
33.10.17.119	32.50.22.120	Handrails for a bathroom and toilet (straight, angular, right, left)
33.10.17.190	32.50.22.190	External breast (mammal gland) prostheses based on silicone gel
33.10.17.415	32.50.22.127	Implants for osteosynthesis
33.10.17.610	32.50.22.129	Roller walkers; collapsible height-regulated legged walkers; supports (legged support walkers, rolled support walkers); handrails (cross-beams) for self-lifting, angular, straight (linear), and folding
33.10.17.710	32.50.22.152	Orthopedic shoes for children
33.10.18.110	26.60.14.120	Deaf-aids, non-implantable
33.10.18.120	32.50.22.128	Crutches
33.10.18.242	32.50.23.000	Artificial feet, polyurethane foam
33.10.18.313	32.50.23.000	Case for residual lower limbs; cosmetic coats for active artificial upper limbs
33.10.20.116	32.50.22.129	Armchairs with hygienic fittings
33.20.53.145	26.51.53.140	Equipment for blood serum protein electrophoresis on cellulose acetate films
33.20.53.310	26.51.53.190	Blood clotting analyzers
33.20.53.311	26.51.53.190	Bilirubin analyzers; urine blood content analyzers; semi-automatic biochemical analyzers; hemoglobin counters
33.20.53.320	26.51.53.190	Glucose counters, personal
33.20.53.332	26.51.53.190	Detecting amplifiers to support real-time polymerase chain reaction studies
35.43.11	30.92.2	Wheeled chairs
36.15.12.129	22.19.71.190	Anti-decubitus orthopedic mattresses, with shape-memory effect; anti-decubitus mattresses with gel elements
36.63.31.120	32.99.21.120	Support canes

<*> While using this list, one should be guided by the code according to the Russian Classification of Products by Types of Economic Activities (OKPD or OKPD2), as well as by the name of the medical device type under the said code.