In connection with the incoming issues on the application of the provisions of the Government Decree Russian Federation of February 5, 2015 No. 102 "On establishing restrictions separate species medical devicesoccurring
of foreign states, for the purposes of procurement to provide state and municipal needs"(Hereinafter referred to as Decree No. 102) in the implementation of the procurement of certain types of medical devices of the Ministry of Economic Development of Russia, the FAS of Russia and the Ministry of Industrial Commission of Russia report the following.
1. On the use of codes of the all-Russian classifier products by type of economic activity (OKPD) OK 034-2007
(hereinafter - classifier).
Resolution No. 102 defined a list of certain types of medical devices from foreign countries in respect of which the restriction of admission is established for procurement purposes
to provide state and municipal needs (hereinafter - the list).
When applying a list (according to a note to it), it is necessary to be guided by both the code in accordance with the classifier and the name of the type of medical product.
For example, according to the classifier (OKPD) OK 034-2007 Code 18.21.21.111 includes "Kits and suits for men, industrial and professional, cotton fabrics". Resolution No. 102 applies only if the specified kits and suits are men's, industrial and professional, cotton fabrics are purchased as medical clothes.
2. On the issue of rejection of applications containing proposals for the supply of medical devices from foreign countries in conducting electronic auctions.
Clause 2 of Resolution No. 102 found that the Customer rejects all applications containing proposals for the supply of medical devices from foreign countries, provided that at least 2 satisfying the requirements for the purchase of applications are submitted to participate in the provider's definition.
In accordance with Part 2 of Article 66 Federal Law dated April 5, 2013 No. 44-FZ "On the contract system in the sphere of procurement of goods, works, services for providing state and municipal needs" (hereinafter - Law No. 44-FZ) Application for participation in the electronic auction consists of two parts.
The Auction Commission created by the Customer is a decision on conformity or on the inconsistency of applications for participation in the electronic auction with the requirements established by the auction documentation on the basis of the results of consideration of the first and second parts of the applications.
Thus, the conclusion on the compliance of the applications filed with the requirements of the auction documentation can be made only according to the results of consideration of the first and second parts of the applications.
Taking into account the following when conducting electronic auction Deviation of applications containing a proposal for the supply of goods of foreign origin with the exception of the Republic of Armenia, the Republic of Belarus and the Republic of Kazakhstan, in accordance with paragraph 2 of Resolution No. 102, it is possible only by the results of consideration by the second parts of the applications.
3. On the issue of the formation of lots when purchasing medical devices included in the list.
In accordance with Article 17 of the Federal Law of July 26, 2006 No. 135-FZ "On Protection of Competition" is prohibited not provided for by federal laws or other regulatory legal acts Restricting access to participation in trading, quotation request, proposal requests.
According to the provisions of Article 8 of Law No. 44-FZ, it is prohibited by customers of any actions that lead to the restriction of competition, in particular to the unreasonable restriction of the number of procurement participants.
In order to apply Resolution No. 102, as well as ensuring competition in procurement, it is not recommended to include medical products included and not included in the list.
4. Please note that Resolution No. 102 does not apply in the implementation of procurement by conducting a request for quotations due to the fact that this method of determining the supplier (contractor, contractor) does not provide for the development of procurement documentation.
Decision
of February 5, 2015 N 102
On the constraints and conditions for the admission of certain types of medical products originating from foreign countries, for the purposes of procurement to provide state and municipal needs
from 02.06.2015 N 528, from 04/22/2016 N 337, from 30.11.2016 N 1268, from 05/30/2017 N 663, from 14.08.2017 N 968, from 11/10/2017 N 1352)
1. Approve the accompanying: from 14.08.2017 N 968)
the list of certain types of medical devices originating from foreign countries for which the restrictions on the admission are established for procurement purposes to provide state and municipal needs (hereinafter - a list of N 1); (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
the list of medical devices of a disposable application (use) from polyvinyl chloride plastics originating from foreign countries for which restrictions on the admission are established for the purposes of procurement to provide state and municipal needs (hereinafter - a list of N 2). (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
2. To establish that for the purposes of procurement of certain types of medical devices included in the list of N 1, the Customer rejects all applications (final proposals) containing proposals for the supply of certain types of medical devices included in the list of N 1 and originating from foreign states (for The exception of the Member States of the Eurasian Economic Union), provided that no less than 2 meet the requirements for the procurement and (or) requests for the purchase of applications (final proposals), which are simultaneously submitted to participate in the provider's definition of the supplier. (as amended by the Decree of the Government of the Russian Federation of 04.04.2016 N 337, from 14.08.2017 N 968)
contain proposals for the supply of certain types of medical devices included in the list of N 1, the country of origin of which is only Member States of the Eurasian Economic Union; (as amended by the Decree of the Government of the Russian Federation of 04.04.2016 N 337, from 14.08.2017 N 968)
do not contain proposals for the supply of one and the same type of medical product of one manufacturer or manufacturers belonging to one group of persons relevant to the signs provided for in Article 9 of the Federal Law "On Competition Protection", with comparison of these applications (final proposals). (as amended by the Decree of the Government of the Russian Federation of 04/22/2016 N 337)
2 (1). In case the application (final proposal), which contains a proposal to supply certain types of medical devices included in the list of N 1 and originating from foreign countries (with the exception of Member States of the Eurasian Economic Union), is not rejected in accordance with the limitations established by this Decision, The conditions for admission are applied for the purposes of procurement of goods originating from a foreign state or a group of foreign states established by federal organ executive powercarrying out functions public Policy and regulatory regulation in the field of procurement of goods, works, services for state and municipal needs. (as amended by the decisions of the Government of the Russian Federation of 04.04.2016 N 337, from 05/30/2017 N 663, from 14.08.2017 N 968)
2 (1.1). To establish that for the purposes of procurement of disposable medical medical devices (use) from polyvinyl chloride plastics included in the list of N 2, the Customer rejects all applications (final proposals), containing proposals for the supply of medical devices of one-time use (use) from polyvinyl chloride plastics included in The list of N 2, provided that the provider's participation in the definition of the provider was submitted at least one satisfying the requirements for the procurement and (or) documentation for the purchase of an application (final offer), which is simultaneously: (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
contains a proposal to supply medical devices of disposable use (use) from polyvinyl chloride plastics included in the list of N 2; (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
served by the organization included in the register of suppliers of these medical devices, provided for by the rules for selecting organizations implementing in 2017 - 2024 comprehensive projects to expand and (or) localization of the production of medical devices (use) from polyvinyl chloride plastics, in order to implement a specific purchase of such products To provide state and municipal needs, approved by Decree of the Government of the Russian Federation of August 14, 2017 N 967 "On the peculiarities of the purchase of medical products of one-time use (use) from polyvinyl chloride plastics to provide state and municipal needs." (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
2 (2). Install that: (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
for the purposes of limiting the admission of certain types of medical devices from foreign states, there can be a subject of one contract (one lot) Medical products included in the list of N 1 and not included in it; (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
for the purposes of procurement of medical devices of one-time use (use) of polyvinyl chloride plastics included in the list of N 2, there can be a subject of one contract (single lot) Medical products included in the list of N 2 and not included in it. (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
2 (3). To establish that for the purposes of procurement of medical devices of one-time use (use) from polyvinyl chloride plastics included in the list of N 2, the purchase documentation should contain initial (maximum) prices calculated in accordance with the methodology approved by the Ministry of Health of the Russian Federation together with the Ministry of Industry and trade of the Russian Federation. (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
3. Confirmation of the country of origin of medical devices included in the list of N 1 is a certificate of origin of goods issued by the authorized body (organization) of the Member States of the Eurasian Economic Union in the form established by the rules for determining the country of origin of goods that are an integral part of the country's definition rules agreement the 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 provided for in specified rules. (as amended by the Decree of the Government of the Russian Federation of 04.04.2016 N 337, from 14.08.2017 N 968)
3 (1). In the execution of the contract, at the conclusion of which were rejected in accordance with the limitations established by this Decision, the Restrictions of the Application (final proposals), which contain proposals for the supply of certain types of medical devices included in the list of N 1 and originating from foreign countries (with the exception of the member states of the Eurasian Economic Economic Union), the replacement of the medical product on the medical product, the country of origin of which is not a member of the Eurasian Economic Union, and the replacement of the manufacturer of the medical product is not allowed. (as amended by the Decree of the Government of the Russian Federation of 04.04.2016 N 337, from 14.08.2017 N 968)
4. The restriction of the admission of certain types of medical devices included in the list of N 1, established by this Decision, is not applied in the following cases: (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
placing notifications on the implementation of procurement of certain types of medical devices included in the list of N 1, in a single information system in the sphere of procurement and (or) the direction of invitations to take part in the definition of the supplier in a closed method, carried out before the entry into force of this Regulation; (as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
the implementation of procurement of certain types of medical devices included in the list of N 1, customers specified in paragraph 1 of Article 75 of the Federal Law "On the Contract System in the Sphere of Procurement of Goods, Works, Services for State and Municipal Needs", in the territory of a foreign state to ensure its own Activities in this area. (as amended by the Decree of the Government of the Russian Federation of 04.04.2016 N 337, from 14.08.2017 N 968)
Chairman of the government
Russian Federation
D.Medvedev
Approved
decree of Government
Russian Federation
of February 5, 2015 N 102
A list of individual types of medical devices from foreign countries in respect of which restrictions on admission are established for procurement purposes to provide state and municipal needs.
(as amended by the decisions of the Government of the Russian Federation of 30.11.2016 N 1268, from 11/10/2017 N 1352)
| Product classifier by types of economic activity (OKPD) OK 034-2007 | Code in accordance with the All-Russian Classifier of Products by Economic Activities (OKPD2) OK 034-2014 | Name of the type of medical devices<*> |
| In connection with the loss of the share of the all-Russian classifier of products by type of economic activity (OKPD), OK 034-2007 should be guided by the all-Russian classifier of products by type of economic activity (OKPD 2) OK 034-2014. | ||
| 17.40.22.149 | 22.19.71.190 | Pillows Anti-Orthopedic with the Effect Memorization 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 clothing |
| 18.21.30.530 | 14.12.30.170 | Special clothing to maintain physical form |
| 21.22.12.350 | 17.22.12.130 | Product sanitary-hygienic - Absorbent linen (diapers (except XS size (ultra-low), diaper) |
| (as amended by the Decree of the Government of the Russian Federation of 10.11.2017 N 1352) | ||
| 24.20.14.190 | 20.20.14.000 | Medical products containing antiseptic and disinfectants |
| 24.41.60.330 24.41.60.399 | 21.10.60.196 | Reagent sets to identify infectious agents by polymerase chain reaction |
| 24.41.60.363 24.41.60.364 | 21.10.60.196 | Sets of reagents for the quantitative and qualitative definition of immunoglobulins or antigen of infectious agents by the method of enzyme immunoassay |
| 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 | Reagent Sets for Neonatal Screening in Dry Blood Stains |
| 24.41.60.384 24.41.60.391 | 21.10.60.196 | Reagent sets for the quantitative determination of hormones by enzyme immunoassay |
| 24.41.60.395 | 21.10.60.196 | Sets of biochemical reagents to determine blood coagulation factors |
| 24.42.13.391 | 21.20.10.139 | |
| 24.42.23.110 | 21.20.23.111 | Reagent sets for determination of blood groups and rhesv factor |
| 24.42.23.111 | 21.20.23.111 | Sets of biochemical reagents to determine enzymes; sets of biochemical reagents to determine blood coagulation factors |
| 24.42.23.119 | 21.20.23.111 | Sets of reagents for human blood phenotyping by group systems Resh, Kell and Kidd |
| 24.42.24.120 | 13.20.44.120 | Marley Medical Bleached Cotton Cotton |
| 24.42.24.120 24.42.24.131 | 21.20.24.160 | Napkins antiseptic alcohol; napkins gauze medical sterile and non-sterile |
| 24.42.24.120 24.42.24.139 | 21.20.24.150 | Cuts gauze medical sterile and non-sterile; medical Sterile Dressing Packages |
| 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, Setton, Turundy, gauze sterile and non-sterile balls |
| 24.42.24.139 | 21.20.24.160 | Wound dressings and coatings impregnated or drug-covered |
| 24.42.24.140 24.42.24.141 24.42.24.142 24.42.24.143 | 14.19.32.120 | Special surgical disposable sterile products from non-woven materials to protect the patient and medical personnel |
| 24.42.24.149 | 21.20.24.150 | Masks gauze medical sterile and non-sterile |
| 24.66.42.140 | 20.59.52.140 | Nutrient media selective and non-selective |
| 24.66.42.310 | 21.20.23.111 | Biochemical reagent sets for substrate definitions |
| 24.66.42.341 | 20.59.52.199 | Sets of biochemical reagents to determine enzymes |
| 24.66.42.389 | 20.59.52.199 | Sets (sets) of reagents for hematological analyzers |
| 25.22.14.210 | 22.22.14.000 | Polymeric biocrust containers |
| 29.23.13.331 29.23.13.335 29.23.13.990 | 28.25.13.111 28.25.13.115 28.25.13.119 | Combined laboratory refrigerators; pharmaceutical refrigerators; medical freezers |
| 29.23.14.110 29.23.14.113 | 28.25.14.110 | Complex equipment for clean rooms; Equipment and devices for filtering, disinfection and (or) air purification |
| 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 obtaining, processing, transmitting and archiving digital medical images |
| 31.50.34.190 | 27.40.39.110 | Operating and viewing medical lamps |
| 33.10.11.111 | 26.60.11.111 | Computer tomographs with slices from 1 to 64 |
| 33.10.11.112 33.10.11.113 | 26.60.11.112 26.60.11.113 | X-ray diagnostic complexes for 2 jobs; x-ray diagnostic complexes for 3 jobs; X-ray diagnostic complexes on the basis of the tele-controlled tablet standal; fluorographs; mammograms; x-ray devices Mobile cerav |
| 33.10.11.113 | 26.60.11.113 | X-ray devices mobile surgical (C-arc) |
| 33.10.11.140 | 26.60.11.120 | Systems of single-photon emission computed tomography (gamma chamber) |
| 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 | Endoscopic complexes |
| 33.10.12.111 | 26.60.12.111 | Electrocardiographs |
| 33.10.12.123 | 26.60.12.123 | Instruments for the study of sound oscillations in human bodies |
| 33.10.12.126 | 26.60.12.129 | Cardiomonitors bedside; complexes of daily electrocardiographic monitoring; glucose analyzers |
| 33.10.12.140 | 26.60.13 | Phototherapeutic neonatal irradiators |
| 33.10.13.119 | 32.50.11.000 | Needles root |
| 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; Tips dental turbine |
| 33.10.15.120 | 32.50.13.110 | Tools stuck; Surgical needles |
| 33.10.15.121 | 32.50.13.110 | Syristers injectors Medical reusable and disposable use with injection needles and without them |
| 33.10.15.130 | 32.50.13.190 | Tools cutting and drums with acute (cutting) edge |
| 33.10.15.134 | 32.50.13.190 | Microsurgical scissors |
| 33.10.15.136 | 32.50.13.190 | Dust cutters; dental heads diamond, including including shaped; tooth carbound bors |
| 33.10.15.140 | 32.50.13.190 | Tools outstanding |
| 33.10.15.144 | 32.50.13.190 | PulpoExtractors |
| 33.10.15.150 | 32.50.13.190 | Multi-surface impact tools |
| 33.10.15.152 | 32.50.13.190 | Microsurgical tweezers |
| 33.10.15.154 | 32.50.13.190 | Microsurgery checkers |
| 33.10.15.160 | 32.50.13.190 | Tools Probing, Burning |
| 33.10.15.180 | 32.50.13.190 | Channel ONEPlizers; auxiliary tools |
| 33.10.15.190 33.10.15.513 | 32.50.1 32.50.13.190 | Electrosurgical devices |
| 33.10.15.212 | 32.50.13.120 | Lamps Slash |
| 33.10.15.213 | 32.50.13.120 | Set of test glasses lenses ophthalmological; Microsurgical instruments for ophthalmology |
| 33.10.15.430 | 32.50.21.112 | Devices for blood transfusion, blood substitutes and infusion solutions, including microfilter |
| 33.10.15.441 | 32.50.21.121 | Inhalation anesthesia |
| 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 | Children's heaters neonatal; neonatal tables with automatic maintenance of the heating temperature of newborns |
| 33.10.15.610 | 32.50.13.190 | Containers for harvesting, storage and transportation of blood; devices with leukocyte filter; devices for infusion of blood resources and infusion solutions |
| 33.10.15.614 | 32.50.13.190 | Urogenital probes; colposcopes; gynecological polymeric mirrors in Cusco; gynecological sites viewing disposable sterile |
| 33.10.15.619 | 32.50.13.190 | Apparatuses of nasal respiratory support for newborns breathing; intensive therapy incubators for newborns; Medical climate modules (clean room) |
| 33.10.15.619 | 32.99.59.000 | Medical Gas and Power Supply Console |
| 33.10.16.122 | 32.50.21.112 | Therapeutic equipment (baths and cabins shower hydromassage) |
| 33.10.17.119 | 32.50.22.120 | Handrails for bathroom and toilet (straight, corner, right, left) |
| 33.10.17.190 | 32.50.22.190 | Exoprostheses of chest (dairy) glands based on silicone gel |
| 33.10.17.415 | 32.50.22.127 | Implants for osteosynthesis |
| 33.10.17.610 | 32.50.22.129 | Walkers on wheels; walkers are walking folding, adjustable in height; Supports (walkers' supports walking, walkers on wheels); Handrails (railing) for self-declaration angular, straight (linear) and folding |
| 33.10.17.710 | 32.50.22.152 | Footwear Orthopedic Children's |
| 33.10.18.110 | 26.60.14.120 | Hearing devices are non-implaised |
| 33.10.18.120 | 32.50.22.128 | Crutches |
| 33.10.18.242 | 32.50.23.000 | Foot artificial polyurethane foam |
| 33.10.18.313 | 32.50.23.000 | Case for the cult of lower extremities; cosmetic shells to active upper extremities |
| 33.10.20.116 | 32.50.22.129 | Chairs-Chairs with Sanitary Equipment |
| 33.20.53.145 | 26.51.53.140 | Devices of electrophoresis proteins of blood serum on films from cellulose acetate films |
| 33.20.53.310 | 26.51.53.190 | Blood coagulation analyzers |
| 33.20.53.311 | 26.51.53.190 | Bilirubin analyzers; protein analyzers in the urine; biochemical analyzers semi-automatic; hemoglobinometry |
| 33.20.53.320 | 26.51.53.190 | Customized glucometters |
| 33.20.53.332 | 26.51.53.190 | Amplifiers detecting to provide research by polymerase chain reaction in real time |
| 35.43.11 | 30.92.2 | Chairs-strollers |
| 36.15.12.129 | 22.19.71.190 | Mattresses are anti-faceted orthopedic with the effect of memorization of the form; mattresses Anti-Rubberies with gel elements |
| 36.63.31.120 | 32.99.21.120 | Very reference |
<*> When applying this list, you should be guided as a code in accordance with All-Russian classifier Products by type of economic activity (OKPD or OKPD2) and the name of the type of medical product of the specified code.
Approved
decree of Government
Russian Federation
on August 14, 2017 N 968
SCROLL
Medical products of disposable application (use) from polyvinyl chloride plastics originating from foreign countries for which restrictions on admission are established for procurement purposes to provide state and municipal needs
(as amended by the Decree of the Government of the Russian Federation of 14.08.2017 N 968)
| Name of medical product | Code in accordance with the All-Russian Classifier of products by type of economic activity (OKPD 2) OK 034-2014 | Medical type code<*> | Name of the type of medical product<*> | Classification Signs of Medical Products<*> |
| 1. Devices for blood transfusion, blood substitutes and infusion solutions | 32.50.13.110 32.50.13.190 | 114090 131660 131850 131880 136330 145530 145570 167580 | devices (systems) for blood transfusion, blood substitutes and infusion solutions, including with a microfiller, for safe transfusion to the patient of the blood and its components, blood substitutes and infusion solutions from polymer and glass containers | |
| 136330 | set basic for intravenous infusion | |||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 131850 | filter for an intravenous infusion system | ||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 131660 | set for extension of a highway for intravenous injections | ||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 131880 | clamp for an infusion system of intravenous injections, with a calibrated circular scale | ||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 114090 | set for intravenous injections from non-conforming material | ||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 167580 | set for intravenous infusion with heating | ||
| Devices for blood transfusion, blood components and blood substitutes (PC) | 145570 | blood Transfusion Set | ||
| 145570 | blood Transfusion Set | |||
| devices for blood transfusion, blood components and blood suppliers with a microfilter (PC with a microfilter) | 145530 | filter for blood transfusion | ||
| 2. Containers for the workpiece, storage and transportation of donor blood and its components | 32.50.13.190 32.50.50.000 | 144260 144270 144290 144300 144310 144320 145490 169870 178820 322610 | containers for the workpiece, storage and transportation of donor blood and its components, including with a leukofilter, to obtain solid blood from a donor and receiving components of donor blood: erythrocyte mass, plasma, platelet concentrate and thrombasecomas, including to obtain blood components, depleted leukocytes | |
| containers for the workpiece, storage and transportation of donor blood and its components without hemoconservants (dry), single-chamber (1000 ml) | ||||
| containers for the workpiece, storage and transportation of donor blood and its components without hemokonesvants (dry), single-chamber (300 - 450 ml) | ||||
| containers for the workpiece, storage and transportation of donor blood and its components without hemoconservants (dry), two-chamber | ||||
| containers for the workpiece, storage and transportation of donor blood and its components with hemokonservant, single-chamber | 144260 | set for donor blood, single-chamber | ||
| Containers for the workpiece, storage and transportation of donor blood and its components with hemoconservant, two-chamber | 144270 | set for donor blood, two-chamber | ||
| containers for the workpiece, storage and transportation of donor blood and its components with hemoconservant, three-chamber | 144320 | |||
| containers for the workpiece, storage and transportation of donor blood and its components with hemoconservant, four-chamber | 144300 | |||
| Containers for the workpiece, storage and transportation of donor blood and its components with hemokonservant | 178820 | |||
| 144320 | set for donor blood, three-chamber | |||
| containers for the workpiece, storage and transportation of donor blood and its components with an integrated leukocyte filter | 178820 | pediatric Donor Blood Set | ||
| Containers for the workpiece, storage and transportation of donor blood and its components with an integrated leukocyte filter | 144300 | set for donor blood, four-chamber | ||
| containers for the workpiece, storage and transportation of donor blood and its components with an integrated leukocyte filter | 144310 | set for donor blood, five-chamber | ||
| containers for the workpiece, storage and transportation of donor blood and its components with an integrated leukocyte filter | 144290 | set for donor blood, multi-chamber | ||
| Polymeric containers for deep freezing (cryopreservation) of donor blood components | 145490 | bloodstone / Tissue Storage or Cultivation Container | ||
| polymeric containers for deep freezing (cryopreservation) of donor blood components of the device for removing leukocytes from donor blood and its components | 169870 | container for the cryservation of samples of IVD, sterile | ||
| devices for removing leukocytes from plasma of donor blood | 322610 | |||
| Devices for removing leukocytes from a plasma of donor blood (bedside) | 322610 | filter for the system of APheresis, for plasma | ||
| 3. Consumables for artificial ventilation of lungs | 32.50.13.190 32.50.50.000 | 110230 151440 165230 173070 185610 185620 185630 185640 218750 275820 318730 324650 322250 327610 327640 | consumables for artificial ventilation devices are disposable, sterile medical products for use in conjunction with an artificial ventilation device of the lungs, for feeding and removing the controlled gas mixture | |
| 275820 | contour respiratory anesthesiological, disposable | |||
| contour respiratory for artificial ventilation of the lungs | 185610 | contour breathing apparatus of artificial ventilation of light, disposable | ||
| 218750 | heat / moisture exchanger / bacterial filter, non-sterile | |||
| filter Respiratory for Lung Artificial Ventilation | 324650 | heat / moisture exchanger / bacterial filter, sterile | ||
| filter Respiratory for Lung Artificial Ventilation | 318730 | bacterial filter for medical gases, non-sterile, disposable | ||
| filter Respiratory for Lung Artificial Ventilation | 322250 | bacterial filter for medical gases, sterile, disposable | ||
| humidifier for the artificial ventilation of the lungs | 173070 | humidifier respiratory mixtures without heating | ||
| 185640 | adapter for an adapter of artificial ventilation of the lungs | |||
| connector / Connector / Adapter for Artificial Ventilation Machine | 327640 | connector tube / mask of the respiratory contour, sterile | ||
| connector / Connector / Adapter for Artificial Ventilation Machine | 165140 | connector for the respiratory contour, disposable | ||
| connector / Connector / Adapter for Artificial Ventilation Machine | 151450 | Connector Y-shaped for the respiratory contour, disposable | ||
| connector / Connector / Adapter for Artificial Ventilation Machine | 327610 | connector tube / mask of the respiratory contour, non-sterile, disposable use | ||
| moisture collector for the artificial ventilation of the lungs | 185620 | moisture assembly of artificial ventilation of light, disposable | ||
| 4. Consumables for donor plasmapheresis / thrombocitheresis | 32.50.13.190 32.50.50.000 | consumables for donor plasmapheresis / thrombocyte - disposable, sterile medical products for use in conjunction with apferase apparatus when billet donor plasma, platelet pools, and stem cells | ||
| set / Set of consumables for the collection of plasma by high-speed centrifugation using HS technology | ||||
| set / Set of consumables for collecting plasma by cross filtering on a rotating membrane filter | ||||
| bell for the apparatus of donor plasmapheresis | ||||
| container with ACD-A Anticoagulant for Donor Plasmapheresis | 145450 | |||
| container with anticoagulant sodium citrate 4% for the apparatus of donor plasmapheresis | 145450 | solution for canning blood containing anticoagulant | ||
| set of containers for the apparatus of donor plasmapheresis, single-chamber | ||||
| set of containers for donor plasmapresis apparatus | set of containers for the apparatus of donor plasmapheresis, two-chamber | |||
| Set of containers for donor plasmapresis apparatus | set of containers for donor plasmapheresis apparatus, three-chamber | |||
| mainstral kit for donor plasmapheresis apparatus | 262870 | set of tubes for the system of apheresis | ||
| set / Set of consumables for donor thrombocitheresis apparatus | ||||
| anticoagulant container for donor thrombocitheresis apparatus | 145450 | solution for canning blood containing anticoagulant | ||
| 5. Consumables for artificial (extracorporeal) circulation | 32.50.13.190 32.50.50.000 | 111480 115570 115610 131520 191470 191560 191600 191610 191680 191770 191800 228290 228320 235170 331910 332960 | consumables for the artificial circulation apparatus (AIC) - disposable, sterile medical products for use in conjunction with artificial blood circulation devices for temporary, complete, or partial replacement of the pump function of the heart when it is impossible to perform it by the organ | |
| set / Set of consumables for artificial blood circulation | ||||
| Set (oxygenator + highway) for artificial blood circulation | ||||
| 115610 | oxygen membrane extracorporal | |||
| oxygenator for artificial blood circulation apparatus | 115570 | oxygen Bubble Extracorporal | ||
| oxygenator for artificial blood circulation apparatus | 131520 | oxygen membrane intravascular | ||
| arterial cannula reinforced for artificial blood circulation | 191600 | cantula for artificial blood circulation, arterial | ||
| Arterial cannula reinforced pediatric for artificial blood circulation | 331910 | cannula for artificial blood circulation Pediatric | ||
| 191610 | ||||
| arterial cannula femoral, for artificial blood circulation | 111480 | kanula Aorthal | ||
| 191470 | caenaly for a cardioplegic solution | |||
| Arterial cannula, for artificial blood circulation | 228290 | cantula for coronary arteries | ||
| arterial cannula, for artificial blood circulation | 228320 | cavory for coronary sinus | ||
| venous cannula femur for artificial blood circulation | 191610 | cannula for artificial blood circulation, femoral | ||
| venous cannula femur bicaval for artificial blood circulation | 191680 | cannula for artificial blood circulation, venous | ||
| venous cannula for artificial blood circulation | 298290 | Cannula transsenteptal for artificial blood circulation systems | ||
| venous cannula with a variable angle for artificial blood circulation apparatus | ||||
| hemokoncentrator for the apparatus of artificial blood circulation | 235170 | hemokoncentrator | ||
| drainage / suction for artificial blood circulation | ||||
| 191560 | set of tubes for an artificial blood circulation system | |||
| set of highways for artificial blood circulation apparatus | 191800 | Set of tubes for primary filling of the system of artificial blood circulation | ||
| set of highways for artificial blood circulation apparatus | 332960 | connector for tubes for artificial blood circulation system | ||
| pump / pump head for artificial blood circulation | 191770 | pump Centrifugal for the system of artificial blood circulation | ||
| 6. Urinary and cathriemics | 152440 152450 152460 152470 156370 156410 156420 200040 221840 221850 255030 | |||
| 152450 | Calipheimer for woven closed, single-component | Calipuritioners for the rehabilitation of patients with violations of the function | ||
| calipurigen one-component | 156410 | calipheimer for open-type intestinal stoma, one-component | selection of feces, during individual diagnoses, after operations, for | |
| 156420 | calipurian for an open-type intestinal stoma, multicomponent | use in the presence of colostomas. Rehabilitation urinary | ||
| two-component cylinderInik (assembled) | 152460 | calipheimer for wicked closed, multicomponent | Violations of natural urine outflows, after operations, for use in the presence of cytosters | |
| 32.50.13.190 32.50.13.110 |
||||
| two-component cylinderInik (assembled) | ||||
| bag for Caloparyamic | ||||
| plate for Caloparyamic | 221840 | calipurian plate, convex | ||
| plate for Caloparyamic | 221850 | calipurian plate, flat | ||
| unicomponent urinary studio | 255030 | stretched single-component bag | ||
| two-component urinary studio | 200040 | strost multicomponent bag | ||
| Bag for urinary | 152470 | Urinary closed Non-type, sterile | ||
| bag for urinary | 152440 | uniform closed wearable, non-sterile | ||
| bag for urinary | 156370 | urinal with drain crane without fastening to the patient, sterile |
<*> Code, name of the type of medical product and its classification features are indicated in accordance with nomenclature classification medical devices approved by the Order of the Ministry of Health of Russia.
Note. When applying this list, it should be guided by the code in accordance with the all-Russian classifier of products by type of economic activity (OKPD 2), and (or) code of the type of medical product in accordance with the nomenclature classification of medical devices, approved by the order of the Ministry of Health of Russia, and (or) the name of the form of medical Products, and (or) classification features of the type of medical product (if available).
Russia has special rules for the procurement of medical devices. If the products are included in the list of PP of the Russian Federation of 05.02.2015 No. 102, customers are obliged to reject applications of foreign suppliers, and manufacturers from EAEU give preferences. How to apply the Resolution 102 from 05.02.2015, taking into account changes in 2019, as well as what changes occurred, read in our material.
List of goods
In PP of the Russian Federation of 05.02.2015 No. 102 included two list. The first contains honeyzedia, when purchasing special conditions for admission for foreign suppliers and manufacturers. In 2019, the list has changed. In particular, the list includes such medical products as:
- 13.20.44.120 - Medical march;
- 12/14/11, 14.12.21, 14.12.30.131, 14.12.30.132, 14.12.30.160 - Medical clothing;
- 21.20.23.111 - Biochemical reagents sets to determine enzymes;
- 21.20.24.131 - Sterile and non-sterile gauze bandages;
- 21.20.24.150 - Medical masks;
- 26.60.11.111 - Tomographs;
- 26.60.11.113 - X-ray devices;
- 26.60.12.132 - Ultrasound scanning devices;
- 30.92.2 - wheelchairs;
- 32.50.21.121, 32.50.21.122, 32.50.21.129 - Lungha artificial ventilation devices Others.
The second list includes the mediamology of one-time application from polyvinyl chloride plastics. It includes blood transfusion devices, containers for its transportation, consumables for artificial ventilation devices of the lungs, for artificial blood circulation devices, etc.
Application
In PP of the Russian Federation of 05.02.2015 No. 102, limitations and rules for the admission of foreign medical medical professions in Gosakaz are established. They act for procurement of goods from special lists. The customer is obliged to reject all applications with products from abroad if at least 2 relevant applications with goods from EAEU countries that do not contain proposals for the supply of one and the same type of honey sizes of one manufacturer.
If disposable medical products are purchased from polyvinyl chloride plastics, the customer should reject all applications with products from abroad, if at least 2 relevant applications that meet the following conditions are submitted:
- contain goods produced by EAEU countries;
- do not contain proposals for the supply of one and the same kind of honey sizes of one manufacturer;
- contain products, in the production of which foreign materials were used in a percentage ratio, relevant to the requirements of PP of the Russian Federation of 14.08.2017 No. 967;
- these are the goods that have documents on their own production of the requirements of GOST ISO 13485-2017.
Since July 9, 2019, the Government has changed a list of foreign medical products with limited admission. From the list were excluded oKPD codes, left OKPD2 and the name of the goods. The article will help to figure out how to customers apply limitations and conditions for admission.
If the conditions are not fulfilled and the Customer has not rejected applications with foreign goods, special conditions apply. Product suppliers produced in EAEU countries provide advantages. They are described in the order of the Ministry of Finance of Russia of 04.06.2018 No. 126n. If the customer conducts a contest, a request for quotations or proposals, the price specified in applications with products from EAEU countries is reduced by 15%. Thus, participants receive an advantage compared with foreign suppliers. If a auction is held, in which a foreign supplier wins, the contract with it concludes at a price by 15% less proposed.
Procurement participants in which restrictions apply, confirm the country's production certificate for origin.
Restrictions do not act if the customer is purchased of goods from the lists outside the Russian Federation - in the territory of a foreign state.
Online procurement check service on the advantages, limitations and prohibitions
The service "Customer's Assistant" will check whether OKPD2 purchases in the lists that require the benefits of disabled organizations and IIS or apply the national regime. Additionally prompt whether the code is included in the auction list and the list of electronic purchases.
Enter the OKPD2 or names for checking and click "Check". Get the result in a second!
Resolution No. 102 with changes for 2019
In 2019, 102 decree was changed three times. From January 2019, the changes introduced by PP of the Russian Federation of December 19, 2018 No. 1590 were entered into force. In particular, in new edition The conditions under which the Customer rejects all applications with products from abroad. Also, the document was completed paragraph 3.2. It says that in the execution of the contract, the replacement of the purchased mediamology to another, produced not in country EAEPprohibited.
From May 30, directions made by PP of the Russian Federation of 15.05.2019 No. 602 came into force. The document added new conditions under which restrictions and special conditions of admission are not applied. This applies to procurement in the framework of the implementation of cross-border and cross-border cooperation programs. The list of Karelia programs, "Colarctic", "Russia - South-Eastern Finland", "Russia - Latvia", "Interreg. The Baltic Sea region and others. As a confirmation of procurement within these programs, it is necessary to provide the conclusion of the Ministry of Industry.
In July, the changes came into force, which made PP of the Russian Federation dated June 26, 2019 No. 813. The list of medical studies from abroad has changed, during the procurement of the restrictions. He replenished with 14 positions. In particular, dressing materials, emptiness, tonometers for measuring intraocular pressure, medical beds and others.
Decree of the Government of the Russian Federation of 05.02.2015 No. 102
On the constraints and conditions for the admission of certain types of medical products originating from foreign countries, for the purposes of procurement to provide state and municipal needs
In accordance with Article 14 of the Federal Law "On the Contract System in the Sphere of Procurement of Goods, Works, Services for State and Municipal Needs" The Government of the Russian Federation decides:
1. Approve the accompanying:
the list of individual types of medical devices originating from foreign countries in respect of which restrictions on admission are established for procurement purposes to provide state and municipal needs (hereinafter - the list No. 1);
the list of medical devices of one-time application (use) from polyvinyl chloride plastics originating from foreign countries for which restrictions on admission are established for procurement purposes to ensure state and municipal needs (hereinafter referred to as the List No. 2).
2. To establish that for the purposes of purchases of certain types of medical devices included in the list No. 1 or list No. 2, the Customer rejects all applications (final proposals) containing proposals for the supply of separate species of these medical devices derived from foreign countries (except Member States of the Eurasian Economic Union), provided that at least 2 applications (final proposals) satisfy the requirements for the purchase of procurement and (or) procurement documentation that are simultaneously submitted to participate in the provider's definition of the supplier.
a) for applications (final proposals) containing proposals for the supply of certain types of medical devices included in the list number 1: contain proposals for the supply of these medical devices, the country of origin of which is only Member States of the Eurasian Economic Union;
b) for applications (final proposals) containing proposals for the supply of medical devices of disposable application (use) from polyvinyl chloride plastics included in the list number 2: contain proposals for the supply of these medical devices, the country of origin of which is only members of the Eurasian Economic Union;
contain proposals for the supply of these medical devices, the percentage of the cost of the materials used (raw materials) of foreign origin in the price of the final products of which corresponds to the Government of the Russian Federation specified in the annex to the Decree of the Government of the Russian Federation of August 14, 2017 No. 967 "On the peculiarities of the purchase of Disposable Medical Products ( use) from polyvinyl chloride plastics to provide state and municipal needs ";
2.1. In case the application (final proposal), which contains a proposal to supply medical devices included in the list No. 1 or a list No. 2 and originating from foreign countries (with the exception of Member States of the Eurasian Economic Union), is not rejected in accordance with the established restrictions, the conditions of admission are applied for the purposes of procurement of goods originating from a foreign state or a group of foreign countries established by the federal executive body that performs functions to develop public policies and regulatory legal regulation in the implementation of the procurement of goods, works, services to ensure public and municipal needs.
2.1.1. The item is additionally included from August 25, 2017 by Decree of the Government of the Russian Federation of August 14, 2017 No. 968; Entry from January 1, 2019 - Resolution of the Government of the Russian Federation of December 19, 2018 No. 1590. - See previous edition.
2.2. Install that:
for the purposes of limiting the admission of certain types of medical devices derived from foreign states, there can be a subject of one contract (one lot) Medical products included in the list No. 1 and not included in it;
for the purposes of procurement of medical devices of disposable application (use) from polyvinyl chloride plastics included in the list number 2, there can be a subject of one contract (one lot) Medical products included in the list number 2 and not included in it.
2.3. It is necessary to establish that for the purposes of the purchase of medical devices of one-time use (use) of polyvinyl chloride plastics included in the list number 2, the procurement documentation should contain initial (maximum) prices calculated in accordance with the methodology approved by the Ministry of Health of the Russian Federation together with the Ministry of Industry and trade of the Russian Federation.
3. Confirmation of the country of origin of medical devices included in the list No. 1 and the list No. 2 is the certificate of origin of the goods issued by the authorized body (organization) of the Member States of the Eurasian Economic Union in the form established by the rules for determining the country of origin of goods that are 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 (hereinafter referred to as the rules), and in accordance with the criteria for determining the country of origin of goods provided for by the rules.
Confirmation of the percentage of the value of the materials (raw materials) of foreign origin in the price of the final product is issued by the Chamber of Commerce and Industry of the Russian Federation an Act of Expertise, containing information on the share of the value of foreign materials (raw materials) used for the production of one unit of medical product, calculated in accordance with sub-clause "B" of clause 2.4 of the rules, or a similar document issued by an authorized body (organization) of the Member State of the Eurasian Economic Union.
3.1. In the execution of the contract, at the conclusion of which were rejected in accordance with the limitations established by this decision, the application restrictions (final proposals), which contain proposals for the supply of certain types of medical devices included in the list of No. 1 and originating from foreign countries (with the exception of the member states of the Eurasian Economic Union), the replacement of the medical product on the medical product, the country of origin of which is not a member of the Eurasian Economic Union, and the replacement of the manufacturer of the medical product is not allowed.
3.2. In the execution of the contract, at the conclusion of which were rejected in accordance with the limitations established by this Decision, the provisions (final offers), containing proposals for the supply of medical devices of one-time use (use) from polyvinyl chloride plastics included in the list No. 2 and originating from foreign states (except Member States of the Eurasian Economic Union), replacement of the medical product for a medical device, the country of origin of which is not a member of the Eurasian Economic Union or the percentage of the value of the materials used (raw materials) of foreign origin in the price of the final products of which is more specified in the annex to the Government Decree of the Russian Federations dated August 14, 2017 № 967 "On the peculiarities of the purchase of medical devices of disposable application (use) from polyvinyl chloride plastics to provide state and municipal Needs "for the appropriate year, and the replacement of the manufacturer of the medical product is not allowed.
4. The limitation of the admission of certain types of medical devices included in the list number 1 is not applied in the following cases.
placement of notifications on the implementation of procurement of certain types of medical devices included in the list number 1, in a unified information system in the field of procurement and (or) the direction of invitations to take part in the provider's definition of the supplier, carried out before the entry into force of this Regulation;
the implementation of procurement of certain types of medical devices included in the list No. 1, customers specified in paragraph 1 of Article 75 of the Federal Law "On the Contract System in the Procurement of Goods, Works, Services for State and Municipal Needs", in the territory of a foreign state to ensure its Activities in this area.
5. To establish that the provisions of this Resolution do not apply in the event of the purchase of goods included in the list No. 1 and the list No. 2 as part of the implementation:
karelia cross-border cooperation programs, the procedure for the implementation of which is provided for by the Agreement on the financing and implementation of the Karelia cross-border cooperation program for the period 2014-2020, signed in Moscow December 29, 2016;
pri-Border Cooperation Programs "Colarctic", the procedure for the implementation of which is provided for by the agreement on financing and implementing the Cross-Border Cooperation Program "Colarctic" for the period 2014-2020, signed in Moscow December 29, 2016;
the program of cross-border cooperation "Russia - South-Eastern Finland", the procedure for the implementation of which is provided for by the agreement on the financing and implementation of the program of cross-border cooperation "Russia - Southeast Finland" for the period 2014-2020, signed in Moscow on December 29, 2016;
the program of cross-border cooperation "Russia-Latvia", the procedure for the implementation of which is provided for by the agreement on financing and implementing the program of cross-border cooperation "Russia-Latvia" for the period 2014-2020, signed in Moscow on December 29, 2016;
the program of cross-border cooperation "Russia-Lithuania", the procedure for the implementation of which is provided for by the agreement on financing and implementing the program of cross-border cooperation "Russia - Lithuania" for the period 2014-2020, signed in Moscow December 29, 2017;
the program of cross-border cooperation "Russia - Poland", the procedure for the implementation of which is provided for by the agreement on financing and implementing the program of cross-border cooperation "Russia - Poland" for the period 2014-2020, signed in the city of Larsav on December 29, 2017;
the programs of cross-border cooperation "Russia - Estonia", the procedure for the implementation of which is provided for by the agreement on financing and implementing the program of cross-border cooperation "Russia - Estonia" for the period 2014-2020, signed in Moscow December 29, 2016;
programs of cross-border cooperation "Interreg. The Baltic Sea Region", the procedure for the implementation of which is provided for by the agreement between the Government of the Russian Federation, the European Commission and the Government of the Federal Republic of Germany on the financial contributions of the Russian Federation and the European Union to ensure the implementation of the transboundary cooperation program "Interreg. Baltic Sea Region" For the period 2014-2020, in the territory of the Russian Federation (financial agreement), signed in the city of Bruissel on January 30, 2018
Confirmation of the procurement of goods as part of the implementation of programs specified in the second paragraphs of the Ninth of this clause, is the conclusion of the Ministry of Industry and Trade of the Russian Federation issued in the manner established by the Ministry of Industry and Trade of the Russian Federation in coordination with the Ministry economic Development Russian Federation.
Chairman of the Government of the Russian Federation D. Medvedev
Nested files
- Resolution No. 102.docx
In accordance with Part 3 of Article 14 of the Federal Law "On the Contract System in the Sphere of Procurement of Goods, Works, Services for State and Municipal Needs" Government of the Russian Federation decides:
1. To approve the attached list of certain types of medical devices originating from foreign countries in respect of which the restriction of admission is established for the purposes of procurement to provide state and municipal needs (hereinafter - the List).
2. To establish that for the purposes of purchasing certain types of medical devices included in the list, the Customer rejects all applications containing proposals for the supply of medical devices from foreign countries, with the exception of the Republic of Armenia, Republic of Belarus and the Republic of Kazakhstan, provided that For participation in the provider's definition filed at least 2 satisfying the requirements of the documentation on the purchase of applications, which are simultaneously:
3. Confirmation of the country of origin of medical devices included in the list is a certificate of origin of goods issued by the authorized body (organization) of the Russian Federation, the Republic of Armenia, the Republic of Belarus or the Republic of Kazakhstan in the form established by the rules for determining the country of origin of goods that are an integral part of the agreement on 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 the goods provided for in these Rules.
4. The limitation of the admission of certain types of medical devices included in the list is not applied in the following cases.
Posting notifications for the purchase of procurement of certain types of medical devices included in the list in a unified information system in the field of procurement and (or) the direction of invitations to take part in the provider's definition by a private method, carried out before the entry into force of this Regulation;
Procurement of certain types of medical devices included in the list, diplomatic missions and consular agencies Of the Russian Federation, trade missions of the Russian Federation and official representative offices of the Russian Federation international organizations To ensure its activities in the territory of a foreign state.
Chairman of the government
Russian Federation
D. Medvedev