of August 20, 2026 No. 1035
About modification of the Order of the Government of the Russian Federation of July 17, 2015 No. 719
The government of the Russian Federation decides:
1. Approve the enclosed changes which are made to appendix to the order of the Government of the Russian Federation of July 17, 2015 No. 719 "About confirmation of production of the Russian industrial output" (The Russian Federation Code, 2015, No. 30, Art. 4597; 2016, No. 33, Art. 5180; 2017, No. 21, Art. 3003; No. 40, Art. 5843; 2021, No. 1, Art. 107; 2023, No. 1, Art. 319; No. 33, Art. 6494; 2024, No. 20, Art. 2625; No. 28, Art. 4023; 2025, No. 25, Art. 3415; 2026, No. 15, Art. 1879; No. 26, Art. 3587; No. 29, Art. 4039).
2. This resolution becomes effective since January 1, 2027.
Russian Prime Minister
M. Mishustin
Approved by the Order of the Government of the Russian Federation of August 20, 2026 No. 1035
1. In the Section VII:
a) the line items classified by codes on OK 034-2014 (KPES 2008) from 32.50.22.195, of 32.50.22.190 "The stent for coronary arteries emitting medicine" from 32.50.22.195, of 32.50.22.190 "Stent for coronary arteries, metal uncovered", from 32.50.13.110 "Catheter balloon standard for angioplasty", to exclude;
b) add with line items of the following content:
|
"from 32.50.22.195, from 32.50.22.190 |
The stents for coronary arteries corresponding to codes 155760, of 155800, 218190 types of medical product according to the nomenclature classification of medical products by types approved by the Ministry of Health of the Russian Federation |
availability the subject of activities in the field of the industry - the tax resident of state members of the Eurasian Economic Union of laws in force on technical documentation for production of the corresponding products with aggregate term of action of such rights, to components has at least 5 years; execution of design documentation on products according to requirements of Uniform system of design documentation, and technological documentation - according to the requirements of the Single system of technological documentation or other documents relating to documents of national system of standardization, except as specified productions according to the license agreement of the localized products when execution of design and technological documentation can not be regulated by the specified requirements; availability at the producer of the existing registration certificate on the corresponding medical products and (or) entries in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products, the state registration of the corresponding medical product confirming the fact with indication of the production site address in the territory of the Russian Federation; availability of the document confirming self-produced compliance to requirements of the state standard specification ISO 13485-2017 standard or relevant international standard of ISO 13485; sterilization of finished goods in the territory of state members of the Eurasian Economic Union |
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|
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use of the component parts, raw materials and materials made in the territories of state members of the Eurasian Economic Union: medicine for covering (when using) (30 points); X-ray contrast markers (30 points); procurements from staly and (or) alloys for hypotube and for seamless metal tube (30 points); |
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|
|
accomplishment of the following technological transactions in the territories of state members of the Eurasian Economic Union: installation of stent on system of delivery (30 points); fixing (compression) of X-ray contrast tags (30 points); assembly of system of delivery (30 points); production of cylinder of system of delivery (30 points); production of tip of catheter (30 points); drawing covering on stent (30 points) (when applicable); production of stent (complete machining, and (or) weaving, and (or) knitting, and (or) casting, and (or) laser cutting, and (or) extrusion, and (or) formation, and (or) method of the additive technologies) (60 points); production of luyer-port and other component parts for system of delivery by method of casting and (or) formation and (or) complete machining (30 points); extrusion of tubes of body of catheter (except internal tube) (90 points); extrusion of internal tube of body of catheter (90 points); production of hypotube (including, when applicable, drawing covering) (30 points); production of seamless metal tube of coronary stent for the subsequent laser cutting of mesh structure of stent (60 points) |
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from 32.50.13.110 |
Catheters balloon for angioplasty, corresponding to code 136170 of type of medical product according to the nomenclature classification of medical products by types approved by the Ministry of Health of the Russian Federation |
availability the subject of activities in the field of the industry - the tax resident of state members of the Eurasian Economic Union of laws in force on technical documentation for production of the corresponding products with aggregate term of action of such rights, to components has at least 5 years; execution of design documentation on products according to requirements of Uniform system of design documentation, and technological documentation - according to the requirements of the Single system of technological documentation or other documents relating to documents of national system of standardization, except as specified productions according to the license agreement of the localized products when execution of design and technological documentation can not be regulated by the specified requirements; availability at the producer of the existing registration certificate on the corresponding medical products and (or) entries in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products, the state registration of the corresponding medical product confirming the fact with indication of the production site address in the territory of the Russian Federation; availability of the document confirming self-produced compliance to requirements of the standard GOST ISO 13485-2017 or relevant international standard of ISO 13485; sterilization of finished goods in the territory of state members of the Eurasian Economic Union; |
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use of the component parts, raw materials and materials made in the territories of state members of the Eurasian Economic Union: X-ray contrast markers (30 points); procurements from staly and (or) alloys for hypotube and for seamless metal tube (30 points); |
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accomplishment of the following technological transactions in the territories of state members of the Eurasian Economic Union: fixing (compression) of X-ray contrast tags (30 points); assembly of system of delivery (30 points); production of cylinder of system of delivery (30 points); production of tip of catheter (30 points); production of luyer-port and other component parts for system of delivery by method of casting and (or) formation and (or) complete machining (30 points); extrusion of tubes of body of catheter (except internal tube) (90 points); extrusion of internal tube of body of catheter (90 points); production of hypotube (including, when applicable, drawing covering) (30 points)". |
2. In the note 28 line items classified by codes on OK 034-2014 (KPES 2008) from 32.50.13.110 "Catheter balloon standard for angioplasty", from 32.50.22.190 "The stent for coronary arteries emitting medicine" from 32.50.22.190 "Stent for coronary arteries, metal uncovered", from 32.50.22.195 "The stent for coronary arteries emitting medicine" from 32.50.22.195 "Stent for coronary arteries, metal uncovered", to exclude.
3. Add with the note 83 following of content:
"83. Products of the medical industry can be carried to the Russian industrial output on condition of achievement in total of the following total number of points for each unit of production:
|
Code on OK 034-2014 (KPES 2008) |
Product name |
2027 |
2028 |
2029 |
2030 and further |
|
from 32.50.22.195, from 32.50.22.190 |
The stents for coronary arteries corresponding to codes 155760, of 155800, 218190 types of medical product according to the nomenclature classification of medical products by types approved by the Ministry of Health of the Russian Federation: |
|
|
|
|
|
|
metal uncovered |
at least 240 points |
at least 330 points |
at least 540 points |
570 points |
|
|
emitting medicine |
at least 270 points |
at least 360 points |
at least 600 points |
630 points |
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from 32.50.13.110 |
Catheters balloon for angioplasty, corresponding to code 136170 of type of medical product according to the nomenclature classification of medical products by types approved by the Ministry of Health of the Russian Federation |
at least 150 points |
at least 240 points |
at least 390 points |
420 points". |
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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