A list of certain types of medical products originating from foreign countries has been approved, for which access restrictions are established for the purposes of procurement to meet state and municipal needs - Rossiyskaya Gazeta.
In connection with incoming questions about the application of the provisions of the Decree of the Government of the Russian Federation of February 5, 2015 No. 102 “On establishing restrictions on the admission of certain types of medical devices originating
from foreign countries, for the purpose of procurement to meet state and municipal needs" (hereinafter - Resolution No. 102) when purchasing certain types of medical products, the Ministry of Economic Development of Russia, the FAS of Russia and the Ministry of Industry and Trade of Russia report the following.
1. On the issue of applying codes of the All-Russian Classifier of Products by Type of Economic Activities (OKPD) OK 034-2007
(hereinafter referred to as the classifier).
Resolution No. 102 defines a list of certain types of medical products originating from foreign countries, in respect of which restrictions on admission are established for procurement purposes
to meet state and municipal needs (hereinafter referred to as the list).
When applying the list (according to the note to it), one should 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 “men's sets and suits, industrial and professional, made of cotton fabrics.” Resolution No. 102 applies only if the specified sets and suits for men, industrial and professional, made of cotton fabrics are purchased as medical clothing.
2. On the issue of rejection of applications containing proposals for the supply of medical devices originating from foreign countries during electronic auctions.
Paragraph 2 of Resolution No. 102 establishes that the customer rejects all applications containing proposals for the supply of medical devices originating from foreign countries, provided that at least 2 applications satisfying the requirements of procurement documentation have been submitted to participate in the determination of the supplier.
In accordance with Part 2 of Article 66 of the Federal Law of April 5, 2013 No. 44-FZ “On the contract system in the field of procurement of goods, works, services to meet state and municipal needs” (hereinafter referred to as Law No. 44-FZ) application for participation in an electronic auction consists of two parts.
The auction commission created by the customer makes a decision on the compliance or non-compliance of applications for participation in the electronic auction with the requirements established by the auction documentation based on the results of consideration of the first and second parts of the applications.
Thus, a conclusion about the compliance of the submitted applications with the requirements of the auction documentation can only be made based on the results of consideration of the first and second parts of the applications.
Taking into account the above, when conducting an electronic auction, rejection of applications containing an offer to supply 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, is possible only based on the results of consideration of the second parts of applications.
3. On the issue of the formation of lots for the purchase of medical products included in the list.
In accordance with Article 17 of the Federal Law of July 26, 2006 No. 135-FZ “On the Protection of Competition”, restriction of access to participation in tenders, request for quotations, request for proposals not provided for by federal laws or other regulatory legal acts is prohibited.
According to the provisions of Article 8 of Law No. 44-FZ, it is prohibited for customers to perform any actions that lead to restriction of competition, in particular to an unreasonable limitation on the number of procurement participants.
In order to apply Resolution No. 102, as well as to ensure competition in procurement, it is not recommended to include medical devices included and not included in the list in one lot.
4. Please note that Resolution No. 102 does not apply when purchasing through a request for quotation due to the fact that this method of identifying a supplier (contractor, performer) does not provide for the development of procurement documentation.
In accordance with Part 3 of Article 14 of the Federal Law "On the contract system in the field of procurement of goods, works, services to meet state and municipal needs" the Government of the Russian Federation decides:
1. Approve the attached list of certain types of medical products originating from foreign countries, in respect of which restrictions on admission are established for the purposes of procurement to meet state and municipal needs (hereinafter referred to as the list).
2. Establish that for the purposes of procurement of certain types of medical devices included in the list, the customer rejects all applications containing proposals for the supply of medical devices originating from foreign countries, with the exception of the Republic of Armenia, the Republic of Belarus and the Republic of Kazakhstan, provided that To participate in the selection of a supplier, at least 2 applications that meet the requirements of the procurement documentation have been submitted, which at the same time:
3. Confirmation of the country of origin of medical devices included in the list is a certificate of origin of goods issued by an 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, which 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 goods provided for by these Rules.
4. The restrictions on the admission of certain types of medical devices included in the list established by this resolution do not apply in the following cases:
Placing notices on procurement of certain types of medical devices included in the list in the unified information system in the field of procurement and (or) sending invitations to participate in the selection of a supplier in a closed way, carried out before the entry into force of this resolution;
Procurement of certain types of medical products included in the list by diplomatic missions and consular offices of the Russian Federation, trade missions of the Russian Federation and official representative offices of the Russian Federation at international organizations to ensure their activities in the territory of a foreign state.
Chairman of the Government
Russian Federation
D. Medvedev
In Russia, there are special rules for the procurement of medical devices. If the products are included in the list from the Russian Federation Regulations dated 02/05/2015 No. 102, customers are required to reject applications from foreign suppliers and give preferences to manufacturers from the EAEU. How to correctly apply Resolution 102 of 02/05/2015, taking into account the changes in 2019, as well as what specific changes have occurred, read in our material.
List of goods
The RF PP dated 02/05/2015 No. 102 includes two lists. The first contains medical products, the purchase of which is subject to special admission conditions for foreign suppliers and manufacturers. The list has undergone changes in 2019. In particular, the list includes such medical products as:
- 13.20.44.120 - medical gauze;
- 14.12.11, 14.12.21, 14.12.30.131, 14.12.30.132, 14.12.30.160 - medical clothing;
- 21.20.23.111 - sets of biochemical reagents for the determination of 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 machines;
- 26.60.12.132 - ultrasonic scanning devices;
- 30.92.2 - wheelchairs;
- 32.50.21.121, 32.50.21.122, 32.50.21.129 - artificial lung ventilation devices and others.
The second list includes disposable medical products made of polyvinyl chloride plastics. It includes devices for blood transfusion, containers for its transportation, consumables for artificial lung ventilation devices, for artificial blood circulation machines, etc.
Application
The RF PP dated 02/05/2015 No. 102 establishes restrictions and rules for the admission of foreign medical products in government orders. They are valid for the purchase of goods from special lists. The customer is obliged to reject all applications with products from abroad if at least 2 corresponding applications with goods from the EAEU countries are submitted, which do not contain proposals for the supply of the same type of medical products from the same manufacturer.
If disposable medical products made from polyvinyl chloride plastics are purchased, the customer should reject all applications with products from abroad if at least 2 qualified applications are submitted that meet the following conditions:
- contain goods produced in EAEU countries;
- do not contain offers for the supply of the same type of medical products from the same manufacturer;
- contain products in the production of which foreign materials were used in a percentage that complies with the requirements of the Russian Federation Regulations dated August 14, 2017 No. 967;
- contain goods that have documents confirming the compliance of their own production with the requirements of GOST ISO 13485-2017.
On July 9, 2019, the Government changed the list of foreign medical devices with limited access. OKPD codes were excluded from the list, leaving OKPD2 and the name of the product. The article will help you understand how customers apply restrictions and admission conditions.
If the conditions are not met and the customer has not rejected applications with foreign-made goods, special admission conditions apply. Suppliers of products manufactured in the EAEU countries are provided with advantages. They are described in the order of the Ministry of Finance of Russia dated June 4, 2018 No. 126n. If the customer conducts a tender, request for quotations or proposals, the price indicated in applications with products from the EAEU countries is reduced by 15%. Thus, participants gain an advantage over foreign suppliers. If an auction is held in which a foreign supplier wins, the contract is concluded with him at a price 15% less than the proposed price.
Participants in procurement where restrictions apply confirm the country of production of the product with a certificate of origin.
Restrictions do not apply if the customer purchases goods from the lists outside the Russian Federation - on the territory of a foreign state.
Online service for checking purchases for advantages, restrictions and prohibitions
The Customer Assistant service will check whether OKPD2 procurement is included in the lists that require the establishment of benefits for organizations of the disabled and the penal system or the application of a national regime. Additionally, it will tell you whether the code is included in the auction list and the list of electronic procurement.
Enter OKPD2 codes or names to check and click the "check" button. Get results in a second!
Resolution No. 102 as amended for 2019
In 2019, Resolution 102 was changed three times. Since January 2019, the changes introduced by the Russian Federation GD dated December 19, 2018 No. 1590 have come into force. In particular, the new edition sets out the conditions under which the customer rejects all applications with products from abroad. The document was also supplemented with clause 3.2. It states that when executing a contract, replacing the purchased medical product with another manufactured outside the EAEU country is prohibited.
On May 30, the amendments made by the Russian Federation GD dated May 15, 2019 No. 602 came into force. New conditions were added to the document under which restrictions and special admission conditions do not apply. This applies to procurement within the framework of cross-border and cross-border cooperation programs. The list included the programs “Karelia”, “Kolarctik”, “Russia - South-Eastern Finland”, “Russia - Latvia”, “Interreg. Baltic Sea Region" and others. As confirmation of purchases under these programs, you must provide a conclusion from the Ministry of Industry and Trade.
In July, changes introduced by Russian Federation Regulation No. 813 of June 26, 2019 came into force. The list of medical products from abroad, the purchase of which is subject to restrictions, has changed. It has been replenished with 14 positions. In particular, dressing materials, otorhinoscopes, tonometers for measuring intraocular pressure, medical beds and others.
Decree of the Government of the Russian Federation dated 02/05/2015 No. 102
On restrictions and conditions for the admission of certain types of medical devices originating from foreign countries for the purposes of procurement to meet state and municipal needs
In accordance with Article 14 of the Federal Law "On the contract system in the field of procurement of goods, works, services to meet state and municipal needs" the Government of the Russian Federation decides:
1. Approve the attached:
a list of certain types of medical products originating from foreign countries, in respect of which access restrictions are established for the purposes of procurement to meet state and municipal needs (hereinafter referred to as list No. 1);
a list of disposable medical products (use) made of polyvinyl chloride plastics originating from foreign countries, in respect of which access restrictions are established for the purposes of procurement to meet state and municipal needs (hereinafter referred to as list No. 2).
2. Establish that for the purposes of procurement of certain types of medical devices included in list No. 1 or list No. 2, the customer rejects all applications (final proposals) containing proposals for the supply of certain types of specified medical products originating from foreign countries (with the exception of member states of the Eurasian Economic Union), provided that at least 2 applications (final proposals) that meet the requirements of the procurement notice and (or) procurement documentation have been submitted to participate in the determination of the supplier, which at the same time:
a) for applications (final proposals) containing proposals for the supply of certain types of medical products included in List No. 1: contain proposals for the supply of the specified medical products, 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 disposable medical products (use) made of polyvinyl chloride plastics included in List No. 2: contain proposals for the supply of the specified medical products, the country of origin of which is only member states of the Eurasian Economic Union;
contain proposals for the supply of the specified medical products, the percentage share of the cost of used materials (raw materials) of foreign origin in the price of the final product corresponds to that specified in the annex to the Decree of the Government of the Russian Federation of August 14, 2017 No. 967 “On the specifics of the purchase of disposable medical products ( use) from polyvinyl chloride plastics to meet state and municipal needs";
2.1. If the application (final offer), which contains a proposal for the supply of medical products included in list No. 1 or list No. 2 and originating from foreign countries (except for member states of the Eurasian Economic Union), is not rejected in accordance with the requirements established by this resolution restrictions, the conditions of admission for the purposes of procurement of goods originating from a foreign state or a group of foreign states, established by the federal executive body exercising the functions of developing state policy and legal regulation in the field of procurement of goods, works, services to ensure public and municipal needs.
2.1.1. The paragraph was additionally included on August 25, 2017 by Decree of the Government of the Russian Federation of August 14, 2017 No. 968; no longer in force on January 1, 2019 - Decree of the Government of the Russian Federation dated December 19, 2018 No. 1590. - See the previous edition.
2.2. Establish that:
for the purpose of limiting the admission of certain types of medical products originating from foreign countries, medical products included in List No. 1 and not included in it cannot be the subject of one contract (one lot);
for the purposes of purchasing disposable medical products (use) made of polyvinyl chloride plastics included in List No. 2, medical products included in List No. 2 and not included in it cannot be the subject of one contract (one lot).
2.3. Establish that for the purposes of purchasing disposable medical products (use) made of polyvinyl chloride plastics included in List No. 2, the procurement documentation must 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 List No. 1 and List No. 2 is a certificate of origin of goods issued by an 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, 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 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 share of the cost of used materials (raw materials) of foreign origin in the price of the final product is an examination certificate issued by the Chamber of Commerce and Industry of the Russian Federation containing information on the share of the cost of foreign materials (raw materials) used for the production of one unit of a medical product, calculated in accordance with subparagraph "c" of paragraph 2.4 of the Rules, or a similar document issued by an authorized body (organization) of a member state of the Eurasian Economic Union.
3.1. When executing a contract, at the conclusion of which applications (final proposals) were rejected in accordance with the restrictions established by this resolution, which contain proposals for the supply of certain types of medical products included in List No. 1 and originating from foreign countries (with the exception of member states of the Eurasian Economic Union), replacement of a medical device with a medical device whose country of origin is not a member state of the Eurasian Economic Union, and replacement of the manufacturer of the medical device are not allowed.
3.2. When executing a contract, at the conclusion of which applications (final proposals) containing proposals for the supply of disposable medical products (use) from polyvinyl chloride plastics included in List No. 2 and originating from foreign countries were rejected in accordance with the restrictions established by this resolution (with the exception of states - members of the Eurasian Economic Union), replacement of a medical product with a medical product whose country of origin is not a member state of the Eurasian Economic Union or the percentage share of the cost of materials used (raw materials) of foreign origin in the price of the final product of which is more than specified in the annex to the resolution of the Government of the Russian Federation Federation dated August 14, 2017 No. 967 “On the specifics of purchasing disposable medical products (use) made of polyvinyl chloride plastics to meet state and municipal needs” for the corresponding year, and replacing the manufacturer of the medical device is not allowed.
4. The restrictions on the admission of certain types of medical devices included in List No. 1 established by this resolution do not apply in the following cases:
posting notices of procurement of certain types of medical devices included in List No. 1 in the unified information system in the field of procurement and (or) sending invitations to participate in the determination of a supplier in a closed way, carried out before the entry into force of this resolution;
procurement of certain types of medical products included in List No. 1 by customers specified in Part 1 of Article 75 of the Federal Law “On the contract system in the field of procurement of goods, works, services to meet state and municipal needs”, on the territory of a foreign state to ensure their activities in this territory.
5. Establish that the provisions of this resolution do not apply in the case of the purchase of goods included in list No. 1 and list No. 2 as part of the sale of:
cross-border cooperation program "Karelia", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Karelia" for the period 2014-2020, signed in Moscow on December 29, 2016;
the Kolarctic cross-border cooperation program, the implementation procedure of which is provided for by the Agreement on the financing and implementation of the Kolarctic cross-border cooperation program for the period 2014-2020, signed in Moscow on December 29, 2016;
cross-border cooperation program "Russia - South-East Finland", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - South-East Finland" for the period 2014-2020, signed in Moscow on December 29, 2016;
cross-border cooperation program "Russia - Latvia", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - Latvia" for the period 2014-2020, signed in Moscow on December 29, 2016;
cross-border cooperation program "Russia - Lithuania", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - Lithuania" for the period 2014-2020, signed in Moscow on December 29, 2017;
the cross-border cooperation program "Russia - Poland", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - Poland" for the period 2014-2020, signed in Warsaw on December 29, 2017;
cross-border cooperation program "Russia - Estonia", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - Estonia" for the period 2014-2020, signed in Moscow on December 29, 2016;
cross-border cooperation program "Interreg. Baltic Sea Region", the implementation procedure 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 financial contributions from the Russian Federation and the European Union in order to ensure the implementation of the cross-border cooperation program "Interreg. Baltic Sea Region" for the period 2014-2020 on the territory of the Russian Federation (financial agreement), signed in Brussels on January 30, 2018.
Confirmation of the purchase of goods within the framework of the implementation of the programs specified in paragraphs two to nine of this paragraph 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 agreement with the Ministry of Economic Development of the Russian Federation.
Chairman of the Government of the Russian Federation D. Medvedev
Attached files
- Resolution No. 102.docx
Article 9 dated 12/19/2018 N 1590)
b) for applications (final proposals) containing proposals for the supply of disposable medical products (use) made of polyvinyl chloride plastics included in List No. 2: (as amended by Decree of the Government of the Russian Federation dated December 19, 2018 N 1590)
do not contain proposals for the supply of the same type of medical product from one manufacturer or manufacturers belonging to the same group of persons corresponding to the criteria provided for in Article 9 of the Federal Law “On Protection of Competition” when comparing these applications (final proposals); (as amended by Decree of the Government of the Russian Federation dated December 19, 2018 N 1590)
contain proposals for the supply of specified medical products, the percentage share of the cost of materials used (raw materials) of foreign origin in the price of the final product corresponds to that specified in the annex to the Decree of the Government of the Russian Federation of August 14, 2017 N 967 “On the specifics of the purchase of disposable medical products ( use) from polyvinyl chloride plastics to meet state and municipal needs"; (as amended by Decree of the Government of the Russian Federation dated December 19, 2018 N 1590)
contain proposals for the supply of the specified medical devices, the production of which has a document confirming the compliance of its own production with the requirements of GOST ISO 13485-2017 "Interstate standard. Medical devices. Quality management systems. Requirements for regulatory purposes." (as amended by Decree of the Government of the Russian Federation dated December 19, 2018 N 1590)
2(1). If the application (final offer), which contains a proposal for the supply of medical products included in List No. 1 or List No. 2 and originating from foreign countries (except for member states of the Eurasian Economic Union), is not rejected in accordance with the requirements established by this resolution restrictions, the conditions of admission for the purposes of procurement of goods originating from a foreign state or a group of foreign states, established by the federal executive body exercising the functions of developing state policy and legal regulation in the field of procurement of goods, works, services to ensure public and municipal needs.
dated 04/22/2016 N 337, dated 05/30/2017 N 663, dated 08/14/2017 N 968, dated 12/19/2018 N 1590) (as amended by Decree of the Government of the Russian Federation dated December 19, 2018 N 1590)
2(1.1). The clause has become invalid.
2(2). The clause has become invalid.
Establish that: The clause has become invalid.
(as amended by Decree of the Government of the Russian Federation dated August 14, 2017 N 968) The clause has become invalid.
for the purpose of limiting the admission of certain types of medical products originating from foreign countries, medical products included in List No. 1 and not included in it cannot be the subject of one contract (one lot); (as amended by Decree of the Government of the Russian Federation dated December 19, 2018 N 1590)
Confirmation of the percentage share of the cost of used materials (raw materials) of foreign origin in the price of the final product is an examination certificate issued by the Chamber of Commerce and Industry of the Russian Federation containing information on the share of the cost of foreign materials (raw materials) used for the production of one unit of a medical product, calculated in accordance with subparagraph "c" of paragraph 2.4 of the Rules, or a similar document issued by an authorized body (organization) of a member state of the Eurasian Economic Union. (as amended by Decree of the Government of the Russian Federation dated December 19, 2018 N 1590)
3(1). When executing a contract, at the conclusion of which applications (final proposals) were rejected in accordance with the restrictions established by this resolution, which contain proposals for the supply of certain types of medical products included in List No. 1 and originating from foreign countries (with the exception of member states of the Eurasian Economic Union), replacement of a medical device with a medical device whose country of origin is not a member state of the Eurasian Economic Union, and replacement of the manufacturer of the medical device are not allowed.
(as amended by Resolutions of the Government of the Russian Federation dated April 22, 2016 N 337, dated August 14, 2017 N 968) (as amended by Decree of the Government of the Russian Federation dated December 19, 2018 N 1590)
3(2) When executing a contract, at the conclusion of which applications (final proposals) containing proposals for the supply of disposable medical products made of polyvinyl chloride plastics included in List No. 2 and originating from foreign countries were rejected in accordance with the restrictions established by this resolution states (except for member states of the Eurasian Economic Union), replacement of a medical product with a medical product whose country of origin is not a member state of the Eurasian Economic Union or the percentage share of the cost of materials used (raw materials) of foreign origin in the price of the final product of which is greater than that specified in the appendix to the Decree of the Government of the Russian Federation of August 14, 2017 N 967 “On the specifics of purchasing disposable medical products (use) made of polyvinyl chloride plastics to meet state and municipal needs” for the corresponding year, and replacing the manufacturer of the medical device is not allowed. The clause has become invalid.
posting notices of procurement of certain types of medical devices included in List No. 1 in the unified information system in the field of procurement and (or) sending invitations to participate in the selection of a supplier in a closed way, carried out before the entry into force of this resolution; The clause has become invalid.
procurement of certain types of medical products included in List No. 1 by customers specified in Part 1 of Article 75 of the Federal Law “On the contract system in the field of procurement of goods, works, services to meet state and municipal needs”, on the territory of a foreign state to ensure their activities in this territory. When executing a contract, at the conclusion of which applications (final proposals) were rejected in accordance with the restrictions established by this resolution, which contain proposals for the supply of certain types of medical products included in List No. 1 and originating from foreign countries (with the exception of member states of the Eurasian Economic Union), replacement of a medical device with a medical device whose country of origin is not a member state of the Eurasian Economic Union, and replacement of the manufacturer of the medical device are not allowed.
5. Establish that the provisions of this resolution do not apply in the case of the purchase of goods included in List No. 1 and List No. 2 as part of the sale of: (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
cross-border cooperation program "Karelia", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Karelia" for the period 2014 - 2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
the Kolarctic cross-border cooperation program, the implementation procedure of which is provided for by the Agreement on the financing and implementation of the Kolarctic cross-border cooperation program for the period 2014 - 2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
cross-border cooperation program "Russia - South-East Finland", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - South-East Finland" for the period 2014 - 2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
cross-border cooperation program "Russia - Latvia", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - Latvia" for the period 2014 - 2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
cross-border cooperation program "Russia - Lithuania", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - Lithuania" for the period 2014 - 2020, signed in Moscow on December 29, 2017; (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
cross-border cooperation program "Russia - Poland", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - Poland" for the period 2014 - 2020, signed in Warsaw on December 29, 2017; (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
cross-border cooperation program "Russia - Estonia", the implementation procedure of which is provided for by the Agreement on the financing and implementation of the cross-border cooperation program "Russia - Estonia" for the period 2014 - 2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
cross-border cooperation program "Interreg. Baltic Sea Region", the implementation procedure 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 financial contributions from the Russian Federation and the European Union in order to ensure the implementation of the cross-border cooperation program "Interreg. Baltic Sea Region" for the period 2014 - 2020 on the territory of the Russian Federation (financial agreement), signed in Brussels on January 30, 2018. (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
Confirmation of the purchase of goods within the framework of the implementation of the programs specified in paragraphs two to nine of this paragraph 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 agreement with the Ministry of Economic Development of the Russian Federation. (as amended by Decree of the Government of the Russian Federation dated May 15, 2019 N 602)
Chairman of the Government
Russian Federation
D.MEDVEDEV
APPROVED
Government resolution
Russian Federation
dated February 5, 2015 N 102
LIST OF CERTAIN TYPES OF MEDICAL DEVICES ORIGINATING FROM FOREIGN STATES, IN REGARD TO WHICH ADMISSION RESTRICTIONS ARE ESTABLISHED FOR THE PURPOSES OF PROCUREMENT TO MEET STATE AND MUNICIPAL NEEDS
(as amended by Decree of the Government of the Russian Federation dated June 26, 2019 N 813)
| Code in accordance with the All-Russian Classifier of Products by Type of Economic Activities (OKPD2) OK 034-2014 | Name of the type of medical products<*> |
| 13.20.44.120 | Bleached cotton medical gauze |
| 14.12.11 14.12.21 14.12.30.131 14.12.30.132 14.12.30.160 | Medical clothing |
| 14.12.30.170 | Special clothing for maintaining physical fitness |
| 14.19.32.120 | Special surgical disposable sterile nonwoven products for patient and medical personnel protection |
| 17.22.12.130 | Sanitary and hygienic products - absorbent linen (diapers (except for size XS (extra small), nappies) |
| 20.13.13.110 | Microsources with iodine-125 |
| 20.20.14.000 | Medical products containing antiseptic and disinfectant preparations |
| 20.59.52.140 | Nutrient media, selective and non-selective |
| 20.59.52.199 21.10.60.196 | Reagent kits for neonatal screening in dried blood spots |
| 20.59.52.199 21.20.10.139 | Sets of reagents for hematology analyzers |
| 20.59.52.199 21.20.23.111 | Sets of biochemical reagents for enzyme determination |
| 21.10.60.196 | Reagent kits for identifying infectious agents using polymerase chain reaction; sets of reagents for the quantitative and qualitative determination of immunoglobulins or antigens of infectious agents by enzyme immunoassay; reagent kits for quantitative determination of hormones by enzyme immunoassay |
| 21.10.60.196 21.20.23.111 | Sets of biochemical reagents for the determination of blood coagulation factors |
| 21.20.23.111 | Sets of biochemical reagents for determining substrates; reagent kits for determining blood groups and Rh factor; sets of reagents for phenotyping human blood according to the Rhesus, Kell and Kidd group systems |
| 21.20.24.110 | Adhesive dressing materials, including those impregnated or coated with drugs |
| 21.20.24.131 | Sterile and non-sterile gauze bandages |
| 21.20.24.150 | Medical gauze masks, sterile and non-sterile; medical gauze cuts, sterile and non-sterile; sterile medical dressing bags; tampons, setons, turundas, sterile and non-sterile gauze balls |
| 21.20.24.160 | Wound dressings and coverings impregnated or coated with drugs; antiseptic alcohol wipes; medical gauze wipes, sterile and non-sterile |
| 22.19.71.190 | Anti-bedsore orthopedic mattresses with shape memory effect; anti-decubitus mattresses with gel elements; orthopedic anti-bedsore pillows with shape memory effect |
| 22.22.14.000 | Polymer containers for biosamples |
| 26.20.13.000 26.20.14.000 | Radiological information systems for obtaining, processing, transmitting and archiving digital medical images |
| 26.51.53.140 | Devices for electrophoresis of serum proteins on cellulose acetate films |
| 26.51.53.190 | Detection amplifiers to provide research using the polymerase chain reaction method in real time; urine protein analyzers; bilirubin analyzers; semi-automatic biochemical analyzers; blood clotting analyzers; hemoglobinometers; individual glucometers |
| 26.51.70.110 | Dry air thermostats |
| 26.60.11.111 | Computer tomographs with the number of slices from 1 to 64 |
| 26.60.11.112 26.60.11.113 | Mammographs; mobile ward X-ray machines; X-ray diagnostic complexes for 2 workplaces; X-ray diagnostic complexes for 3 workplaces; X-ray diagnostic complexes based on a remote-controlled tripod table; fluorographs |
| 26.60.11.113 | Mobile surgical X-ray devices (C-arm) |
| 26.60.11.113 26.60.12.110 26.60.12.129 32.50.1 32.50.21.112 | Endoscopic complexes |
| 26.60.11.120 | Single-photon emission computed tomography systems (gamma cameras) |
| 26.60.11.120 26.60.11.129 | Devices, devices and complexes for gamma therapeutic contact radiation therapy of medium and high dose rates |
| 26.60.12.111 | Electrocardiographs |
| 26.60.12.119 26.60.12.129 27.40.39.110 32.50.13.190 | Otorhinoscopes |
| 26.60.12.119 26.60.12.129 32.50.13 | Tonometers for measuring intraocular pressure |
| 26.60.12.123 | Instruments for studying sound vibrations in human organs |
| 26.60.12.129 | Glucose analyzers; bedside cardiac monitors; 24-hour electrocardiographic monitoring complexes |
| 26.60.12.132 | Ultrasound scanning devices |
| 26.60.13 | Neonatal phototherapeutic irradiators |
| 26.60.13.190 32.50.13.190 | Defibrillators; children's neonatal heaters; neonatal tables with automatic temperature maintenance for heating newborns |
| 26.60.14.120 | Non-implantable hearing aids |
| 27.40.39.110 | Operating and examination medical lights |
| 28.25.13.111 28.25.13.115 28.25.13.119 | Medical freezers; combined laboratory refrigerators; pharmaceutical refrigerators |
| 28.25.14.110 | A set of equipment for clean rooms; equipment and devices for filtering, disinfecting and (or) air purification |
| 30.92.2 | Wheelchairs |
| 32.50.1 32.50.13.190 | Electrosurgical devices |
| 32.50.11.000 | Root needles |
| 32.50.12.000 | Air sterilizers; steam sterilizers |
| 32.50.13.110 | Surgical needles; piercing instruments; medical syringes-injectors, reusable and disposable, with and without injection needles |
| 32.50.13.120 | Slit lamps; intraocular lenses; microsurgical instruments for ophthalmology; ophthalmic lens trial set |
| 32.50.13.190 | Nasal respiratory support devices for newborns; carbide dental burs; dental diamond heads, including shaped ones; containers for collecting, storing and transporting biological samples for clinical laboratory research, including vacuum tubes for collecting venous blood, tubes for collecting capillary blood, containers for urine, feces and sputum; gynecological polymer speculum in Cusco; urogenital probes; microsurgical needle holders; intensive care incubators for newborns; auxiliary tools; probing and bougie instruments; multi-surface impact tools; pushing tools; cutting and impact tools with a sharp (cutting) edge; channel fillers; colposcopes; pneumatic micromotors for dental handpieces; air-conditioned medical modules (clean room); disposable sterile gynecological examination kits; tips for micromotors; dental turbine handpieces; microsurgical scissors; microsurgical forceps; pulp extractors; dental cutters |
| 32.50.21.112 | Therapeutic equipment (baths and hydromassage showers) |
| 32.50.21.121 | Devices for inhalation anesthesia |
| 32.50.21.121 32.50.21.122 32.50.21.129 | Ventilators |
| 32.50.22.110 32.50.22.190 | Endoprostheses of limb joints |
| 32.50.22.120 | Handrails for bathrooms and toilets (straight, corner, right, left) |
| 32.50.22.127 | External fixation devices; implants for osteosynthesis |
| 32.50.22.128 | Crutches |
| 32.50.22.129 | Chairs with sanitary equipment; supports (walking supports, walkers on wheels); handrails (railings) for self-lifting, angular, straight (linear) and folding; walkers on wheels; folding walking walkers, height adjustable |
| 32.50.22.152 | Orthopedic shoes for children |
| 32.50.22.190 | Exoprostheses of the mammary glands based on silicone gel |
| 32.50.23.000 | Cosmetic covers for active prostheses of the upper limbs; artificial polyurethane foam feet; cover for the stump of the lower limbs |
| 32.50.30.110 | Medical functional beds |
| 32.99.21.120 | Support canes |
| 32.99.59.000 | Consoles for supplying medical gases and power supplies |
<*>When applying this list, you should be guided by both the code in accordance with the All-Russian Classifier of Products by Type of Economic Activities (OKPD2) and the name of the type of medical device.
APPROVED
Government resolution
Russian Federation
dated August 14, 2017 N 968
SCROLL
DISPOSABLE MEDICAL PRODUCTS (USE) FROM POLYVINYL CHLORIDE PLASTICS ORIGINATING FROM FOREIGN COUNTRIES, WHICH ARE SUBJECT TO ADMISSION RESTRICTIONS FOR GOVERNMENT PROCUREMENT PURPOSES OF PUBLIC AND MUNICIPAL NEEDS
(as amended by Decree of the Government of the Russian Federation dated August 14, 2017 N 968)
| Name of medical product | Code in accordance with the All-Russian Classifier of Products by Type of Economic Activities (OKPD 2) OK 034-2014 | Medical product type code<*> | Name of the type of medical product<*> | Classification characteristics of the type of medical device<*> |
| 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 transfusion of blood, blood substitutes and infusion solutions, including with a microfilter, for the safe transfusion of blood and its components, blood substitutes and infusion solutions from polymer and glass containers to a patient | |
| 136330 | basic set for intravenous infusions | |||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 131850 | filter for intravenous infusion system | ||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 131660 | IV line extension kit | ||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 131880 | clamp for IV infusion system, with calibrated dial | ||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 114090 | set for intravenous infusions made of non-absorbent material | ||
| devices for transfusion of infusion solutions and blood substitutes (PR) | 167580 | heated IV set | ||
| devices for transfusion of blood, blood components and blood substitutes (PC) | 145570 | blood transfusion kit | ||
| 145570 | blood transfusion kit | |||
| devices for transfusion of blood, blood components and blood substitutes with a microfilter (PC with a microfilter) | 145530 | blood transfusion filter | ||
| 2. Containers for the preparation, 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 preparation, storage and transportation of donor blood and its components, including with a leukofilter, for obtaining whole blood from a donor and obtaining components of donor blood: red blood cells, plasma, platelet concentrate and thromboleukomass, including for obtaining depleted blood components leukocytes | |
| containers for the collection, storage and transportation of donor blood and its components without hemopreservatives (dry), single-chamber (1000 ml) | ||||
| containers for the procurement, storage and transportation of donor blood and its components without hemopreservatives (dry), single-chamber (300 - 450 ml) | ||||
| containers for the procurement, storage and transportation of donor blood and its components without hemopreservatives (dry), two-chamber | ||||
| containers for the procurement, storage and transportation of donor blood and its components with a hemopreservative, single-chamber | 144260 | set for donor blood, single chamber | ||
| containers for the procurement, storage and transportation of donor blood and its components with a hemopreservative, two-chamber | 144270 | kit for donor blood, two-chamber | ||
| containers for the procurement, storage and transportation of donor blood and its components with a hemopreservative, three-chamber | 144320 | |||
| containers for the procurement, storage and transportation of donor blood and its components with a hemopreservative, four-chamber | 144300 | |||
| containers for the procurement, storage and transportation of donor blood and its components with a hemopreservative | 178820 | |||
| 144320 | set for donor blood, three-chamber | |||
| containers for the collection, storage and transportation of donor blood and its components with an integrated leukocyte filter | 178820 | pediatric blood donation kit | ||
| containers for the collection, storage and transportation of donor blood and its components with an integrated leukocyte filter | 144300 | set for donor blood, four-chamber | ||
| containers for the collection, storage and transportation of donor blood and its components with an integrated leukocyte filter | 144310 | set for donor blood, five-chamber | ||
| containers for the collection, storage and transportation of donor blood and its components with an integrated leukocyte filter | 144290 | kit for donor blood, multi-chamber | ||
| polymer containers for deep freezing (cryopreservation) of donor blood components | 145490 | blood/tissue storage or culture container | ||
| polymer containers for deep freezing (cryopreservation) of donor blood components devices for removing leukocytes from donor blood and its components | 169870 | container for cryostorage of IVD samples, sterile | ||
| devices for removing leukocytes from donor blood plasma | 322610 | |||
| devices for removing leukocytes from donor blood plasma (bedside) | 322610 | filter for apheresis system, for plasma | ||
| 3. Consumables for ventilators | 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 lung ventilation devices - disposable, sterile medical products for use in conjunction with an artificial lung ventilation device, for supplying and removing a controlled gas mixture | |
| 275820 | anesthesiological breathing circuit, disposable | |||
| breathing circuit for ventilator | 185610 | breathing circuit of artificial lung ventilation device, disposable | ||
| 218750 | heat/moisture exchanger/bacterial filter, non-sterile | |||
| breathing filter for ventilator | 324650 | heat/moisture exchanger/bacterial filter, sterile | ||
| breathing filter for ventilator | 318730 | bacterial filter for medical gases, non-sterile, disposable | ||
| breathing filter for ventilator | 322250 | bacterial filter for medical gases, sterile, disposable | ||
| humidifier for ventilator | 173070 | humidifier of respiratory mixtures without heating | ||
| 185640 | adapter for ventilator | |||
| connector/connector/adapter for ventilator | 327640 | breathing circuit tube/mask connector, sterile | ||
| connector/connector/adapter for ventilator | 165140 | Breathing circuit connector, disposable | ||
| connector/connector/adapter for ventilator | 151450 | Y-connector for breathing circuit, disposable | ||
| connector/connector/adapter for ventilator | 327610 | Tube/mask breathing circuit connector, non-sterile, single use | ||
| moisture collector for ventilator | 185620 | ventilator moisture collector, disposable | ||
| 4. Consumables for donor plasmapheresis/plateletpheresis devices | 32.50.13.190 32.50.50.000 | consumables for donor plasmapheresis/platelet pheresis devices - disposable, sterile medical products for use in conjunction with apheresis devices for the preparation of donor plasma, platelet pools, and stem cells | ||
| set/set of consumables for plasma collection by high-speed centrifugation using HS technology | ||||
| set/set of consumables for plasma collection using cross-filtration method on a rotating membrane filter | ||||
| bell for donor plasmapheresis apparatus | ||||
| container with anticoagulant ACD-A for donor plasmapheresis device | 145450 | |||
| container with anticoagulant sodium citrate 4% for donor plasmapheresis device | 145450 | blood preservation solution containing an anticoagulant | ||
| set of containers for donor plasmapheresis apparatus, single-chamber | ||||
| set of containers for donor plasmapheresis apparatus | set of containers for donor plasmapheresis apparatus, two-chamber | |||
| set of containers for donor plasmapheresis apparatus | set of containers for donor plasmapheresis apparatus, three-chamber | |||
| set of lines for donor plasmapheresis apparatus | 262870 | set of tubes for apheresis system | ||
| set/set of consumables for donor plateletpheresis apparatus | ||||
| container with anticoagulant for donor plateletpheresis device | 145450 | blood preservation solution containing an anticoagulant | ||
| 5. Consumables for artificial (extracorporeal) blood circulation machines | 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 heart-lung machine (CAB) - disposable, sterile medical products for use in conjunction with heart-lung machines for temporary, complete or partial replacement of the pumping function of the heart if it is impossible for the organ to perform it | |
| set/set of consumables for heart-lung machine | ||||
| set (oxygenator + lines) for heart-lung machine | ||||
| 115610 | extracorporeal membrane oxygenator | |||
| oxygenator for heart-lung machine | 115570 | extracorporeal bubble oxygenator | ||
| oxygenator for heart-lung machine | 131520 | intravascular membrane oxygenator | ||
| reinforced arterial cannula for heart-lung machine | 191600 | cannula for cardiopulmonary bypass, arterial | ||
| reinforced pediatric arterial cannula for heart-lung machine | 331910 | pediatric cardiopulmonary bypass cannula | ||
| 191610 | ||||
| femoral arterial cannula, for heart-lung machine | 111480 | aortic cannula | ||
| 191470 | cannula for cardioplegic solution | |||
| arterial cannula, for heart-lung machine | 228290 | coronary artery cannula | ||
| arterial cannula, for heart-lung machine | 228320 | coronary sinus cannula | ||
| femoral venous cannula, for heart-lung machine | 191610 | cannula for cardiopulmonary bypass, femoral | ||
| femoral bicaval venous cannula for heart-lung machine | 191680 | cannula for cardiopulmonary bypass, venous | ||
| venous cannula for heart-lung machine | 298290 | transseptal cannula for artificial circulation systems | ||
| venous cannula with variable angle for heart-lung machine | ||||
| hemoconcentrator for heart-lung machine | 235170 | hemoconcentrator | ||
| drainage/suction for heart-lung machine | ||||
| 191560 | set of tubes for cardiopulmonary bypass system | |||
| set of lines for heart-lung machine | 191800 | set of tubes for primary filling of the artificial circulation system | ||
| set of lines for heart-lung machine | 332960 | tube connector for cardiopulmonary bypass system | ||
| pump/pump head for heart-lung machine | 191770 | centrifugal pump for artificial circulation system | ||
| 6. Urinals and colostomy bags | 152440 152450 152460 152470 156370 156410 156420 200040 221840 221850 255030 | |||
| 152450 | colostomy bag, closed, one-component | colostomy bags for the rehabilitation of patients with dysfunction | ||
| single-component colostomy bag | 156410 | colostomy bag for open intestinal stoma, one-component | fecal discharge, for certain diagnoses, after operations, for | |
| 156420 | colostomy bag for open intestinal stoma, multi-component | use in the presence of colostomy. Urinals for rehabilitation | ||
| two-component colostomy bag (assembled) | 152460 | colostomy bag, closed, multi-component | disorders of the natural outflow of urine, after operations, for use in the presence of a cytostomy | |
| 32.50.13.190 32.50.13.110 |
||||
| two-component colostomy bag (assembled) | ||||
| colostomy bag | ||||
| plate for colostomy bag | 221840 | colostomy bag plate, convex | ||
| plate for colostomy bag | 221850 | colostomy bag plate, flat | ||
| single-component urinal | 255030 | single-component urostomy bag | ||
| two-component urinal | 200040 | multicomponent urostomy bag | ||
| urine bag | 152470 | closed, non-wearable urinal, sterile | ||
| urine bag | 152440 | closed portable urinal, non-sterile | ||
| urine bag | 156370 | urinal with drain tap without attachment to the patient, sterile |
<*>The code, name of the type of medical device and its classification characteristics are indicated in accordance with the nomenclature classification of medical devices approved by order of the Ministry of Health of Russia.
Note. When applying this list, you should be guided by the code in accordance with the All-Russian Classifier of Products by Type of Economic Activities (OKPD 2), and (or) the code of the type of medical product in accordance with the nomenclature classification of medical products, approved by order of the Ministry of Health of Russia, and (or) the name of the type of medical product, and (or) classification characteristics of the type of medical product (if available).
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