Restrictions in medical device sales

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)

  1. 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)

  1. 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)

  1. 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.