Resolution of the Government of the Russian Federation No. 860 of June 26, 2024

On Amendments to Resolution of the Government of the Russian Federation No. 894 of May 31, 2023

The Government of the Russian Federation RESOLVES:

Clause 1 shall enter into force on March 1, 2025.

1. Approve the annexed amendments to be introduced to Resolution of the Government of the Russian Federation No. 894 of May 31, 2023 "On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means and on the Specifics of Implementing the State Information System for Monitoring the Circulation of Goods Subject to Mandatory Marking with Identification Means in Respect of Certain Types of Medical Devices" (Collected Legislation of the Russian Federation, 2023, No. 23, Art. 4204; 2024, No. 15, Art. 2031).

2. Establish that:

• through February 28, 2025 (inclusive), participants in the circulation of certain types of medical devices shall have the right to mark medical gloves with identification means (codes of the unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union 3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, codes of the Russian Classification of Products by Economic Activity 14.12.30.160, 22.19.60.111, 22.19.60.113, 22.19.60.119, 22.19.71.190, 22.29.10.120, 32.50.13.190, 32.50.50.190, medical device type codes in accordance with the nomenclature classification of medical devices 122540, 122560, 122610, 122630, 122640, 129800, 129900, 130220, 139310, 139350, 139360, 156530, 169840, 185700, 185720, 185830, 185850, 201590, 201600, 201610, 205280, 205290, 257300, 298450, 311720, 316120, 318420, 320790, 321530, 322780, 323740, 326340, 329770, 349230, 351490, 388560) provided that information on the marking of such medical gloves with identification means is submitted to the state information system for monitoring the circulation of goods subject to mandatory marking with identification means in accordance with the Rules for Marking Certain Types of Medical Devices with Identification Means, approved by Resolution of the Government of the Russian Federation No. 894 of May 31, 2023 "On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means and on the Specifics of Implementing the State Information System for Monitoring the Circulation of Goods Subject to Mandatory Marking with Identification Means in Respect of Certain Types of Medical Devices";

• the operator of the state information system for monitoring the circulation of goods subject to mandatory marking with identification means shall ensure the provision to participants in the circulation of certain types of medical devices engaged in marking medical gloves with identification means in accordance with paragraph two of this clause of marking codes necessary for generating identification means, provided that all information necessary for registering medical gloves, as provided for in paragraph two of this clause, is submitted to the state information system for monitoring the circulation of goods subject to mandatory marking with identification means in accordance with the Rules for Marking Certain Types of Medical Devices with Identification Means, approved by Resolution of the Government of the Russian Federation No. 894 of May 31, 2023 "On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means and on the Specifics of Implementing the State Information System for Monitoring the Circulation of Goods Subject to Mandatory Marking with Identification Means in Respect of Certain Types of Medical Devices."

3. The Ministry of Industry and Trade of the Russian Federation shall, in 2027, conduct an assessment of the application of the mandatory requirements introduced by this Resolution.

4. This Resolution shall enter into force on the date of its official publication, with the exception of Clause 1 of this Resolution, which shall enter into force on March 1, 2025.

Chairman of the Government
of the Russian Federation
M. MISHUSTIN

Approved
by Resolution of the Government
of the Russian Federation
No. 860 of June 26, 2024

AMENDMENTS
TO BE INTRODUCED TO RESOLUTION OF THE GOVERNMENT
OF THE RUSSIAN FEDERATION NO. 894 OF MAY 31, 2023

1. Clause 3 shall be supplemented with subclauses "e" through "i" reading as follows:
   "e) participants in the circulation of certain types of medical devices holding a valid registration certificate for a medical device, who introduce medical gloves into circulation, shall apply identification means to the consumer packaging, including by affixing to such consumer packaging a label containing the identification means, of medical gloves and shall submit to the monitoring information system information on the application of identification means and on the introduction into circulation of medical gloves (codes of the unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union 3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, codes of the Russian Classification of Products by Economic Activity 14.12.30.160, 22.19.60.111, 22.19.60.113, 22.19.60.119, 22.19.71.190, 22.29.10.120, 32.50.13.190, 32.50.50.190, medical device type codes in accordance with the nomenclature classification of medical devices 122540, 122560, 122610, 122630, 122640, 129800, 129900, 130220, 139310, 139350, 139360, 156530, 169840, 185700, 185720, 185830, 185850, 201590, 201600, 201610, 205280, 205290, 257300, 298450, 311720, 316120, 318420, 320790, 321530, 322780, 323740, 326340, 329770, 349230, 351490, 388560) in accordance with the Rules approved by this Resolution, from March 1, 2025;
   f) participants in the circulation of certain types of medical devices shall submit to the monitoring information system in accordance with the Rules approved by this Resolution information on the withdrawal from circulation of certain types of medical devices specified in subclause "e" of this clause, from March 1, 2025, and information on the circulation of certain types of medical devices in accordance with the Rules approved by this Resolution, from September 1, 2025;
   g) through March 31, 2025 (inclusive), participants in the circulation of certain types of medical devices shall mark medical gloves specified in subclause "e" of this clause, purchased through February 28, 2025 (inclusive), imported (brought in) and released by customs authorities from March 1, 2025 in accordance with the customs procedure of release for domestic consumption or reimportation, before offering such medical gloves for sale (retail), shall enter into the monitoring information system information on the marking of such medical gloves with identification means and shall introduce them into circulation in accordance with the Rules approved by this Resolution;
   h) participants in the circulation of certain types of medical devices who, as of March 1, 2025, hold unsold medical gloves specified in subclause "e" of this clause, produced on the territory of the Russian Federation or imported into the territory of the Russian Federation through February 28, 2025 (inclusive), shall have the right through August 31, 2025 (inclusive) to sell such medical gloves without marking with identification means or to mark such medical gloves with identification means and submit information on marking with identification means to the monitoring information system in accordance with the Rules approved by this Resolution.
   At the same time, participants in the circulation of certain types of medical devices who have acquired such medical gloves for the purpose of carrying out activities in the field of healthcare and providing social and medical services shall have the right to store, transport, and gratuitously transfer the medical gloves provided for in the first paragraph of this subclause without marking with identification means and to sell (retail) such medical gloves in accordance with the first paragraph of this subclause.
   When carrying out marking with identification means of medical gloves in the case specified in the first paragraph of this subclause, the participant in the circulation of certain types of medical devices shall register such medical gloves in the subsystem of the national catalog of marked goods of the monitoring information system and indicate the information provided for in Clause 41(1) of the Rules approved by this Resolution, shall ensure their marking with identification means, and shall also submit information on their marking with identification means to the monitoring information system in accordance with the Rules approved by this Resolution.
   Payment for marking codes necessary for generating identification means for medical gloves specified in the first paragraph of this subclause shall be made in accordance with the Rules approved by this Resolution."

2. In Clause 6:
   a) the first paragraph shall be amended to read as follows:
   "6. Establish that on the territory of the Russian Federation, the introduction into circulation of certain types of medical devices without applying identification means to the consumer packaging, including by affixing to such consumer packaging a label containing the identification means, of certain types of medical devices and without submitting to the monitoring information system information on the marking of certain types of medical devices with identification means shall be permitted until the dates established by subclauses "a" and "e" of Clause 3 of this Resolution, from which the application of identification means to the consumer packaging, including by affixing to such consumer packaging a label containing the identification means, of such certain types of medical devices and the submission of information to the monitoring information system become mandatory, with the exception of the cases specified in the first paragraph of subclause "d" and the first paragraph of subclause "i" of Clause 3 of this Resolution;"
   b) in the second paragraph, after the words "the fourth paragraph of subclause 'd'" add the words "and the first paragraph of subclause 'i'";
   c) in the third paragraph, replace the words "subclause 'c' of Clause 3" with the words "subclauses 'c' and 'g' of Clause 3";
   d) add a paragraph reading as follows:
   "in respect of medical gloves through March 31, 2025 (inclusive)."

3. In the Rules for Marking Certain Types of Medical Devices with Identification Means, approved by the said Resolution:
   a) the forty-seventh paragraph of Clause 2 shall be amended to read as follows:
   "'goods' - certain types of medical devices holding a valid registration certificate, in respect of disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), orthopedic footwear and corrective insole elements for orthopedic footwear (including insoles, partial insoles), hearing aids, except for parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence, medical gloves, corresponding to codes of the unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union (hereinafter - the commodity nomenclature) 3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, 8421 39 200 8, 8421 39 800 6, 8539 49 000 0, 9018 20 000 0, 9021 10 100 0, 9021 40 000 0, 9021 90 900 1, 9022 12 000 0, 9022 13 000 0, 9022 14 000 0, 9022 19 000 0, 9619 00 890, codes of the Russian Classification of Products by Economic Activity 14.12.30.160, 17.22.12.130, 22.19.60.111, 22.19.60.113, 22.19.60.119, 22.19.71.190, 22.29.10.120, 26.60.11.111, 26.60.11.113, 26.60.11.119, 26.60.14.120, 28.25.14.110, 32.50.13.190, 32.50.22.150, 32.50.22.151, 32.50.22.152, 32.50.22.155, 32.50.22.156, 32.50.22.157, 32.50.22.190, 32.50.22.195, 32.50.50.190 and medical device type codes in accordance with the nomenclature classification of medical devices 113850, 122540, 122560, 122610, 122630, 122640, 126750, 129800, 129900, 130220, 131980, 135190, 135820, 139310, 139350, 139360, 142570, 152690, 152700, 155760, 155800, 155820, 156530, 169840, 173110, 182750, 185700, 185720, 185830, 185850, 201590, 201600, 201610, 202800, 202810, 204370, 205280, 205290, 209360, 210000, 218190, 228560, 233730, 233860, 233900, 250220, 250230, 250250, 250260, 257300, 273880, 280360, 280730, 282030, 292620, 298450, 302870, 311720, 316120, 318420, 320550, 320560, 320790, 321530, 322780, 323740, 326340, 329770, 331320, 331330, 331830, 336330, 343410, 343540, 343580, 343610, 349230, 351490, 356150, 375930, 388560;"
   b) Clause 28:
   after the fourth paragraph, add a paragraph reading as follows:
   "From March 1, 2025, participants in the circulation of goods shall submit to the monitoring information system information on identification codes, and/or identification codes of group packaging, and/or identification codes of sets, and/or identification codes of transport packaging when introducing into circulation and when withdrawing from circulation medical gloves.";
   c) add Clause 41(1) reading as follows:
   "41(1). To register medical gloves in the subsystem of the national catalog of marked goods, a participant in the circulation of goods shall submit the following information on the goods being registered:
   a) taxpayer identification number of the applicant;
   b) goods code (if available);
   c) full name of the goods;
   d) trademark (if available);
   e) 10-digit code of the commodity nomenclature;
   f) country of production code in accordance with the Russian Classification of Countries of the World;
   g) goods category;
   h) goods type;
   i) number of units of consumption in the consumer packaging;
   j) product size;
   k) composition;
   l) registration certificate number for the medical device and name of the medical device model;
   m) number and date of the declaration of conformity (if available);
   n) shelf life or service life, number of months (for service life).";
   d) in Clause 43, replace the words "in Clauses 37-41" with the words "in Clauses 37-41(1)";
   e) in the third paragraph of Clause 44, after the words "and/or 41," add the words "and/or 41(1),".