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Government of the Russian Federation resolution No. 860

Government of the Russian Federation resolution No. 860

GOVERNMENT OF THE RUSSIAN FEDERATION

 

RESOLUTION

dated June 26, 2024, No. 860

 

ON AMENDING RESOLUTION OF THE GOVERNMENT OF THE RUSSIAN FEDERATION DATED MAY 31, 2023, No. 894

The Government of the Russian Federation resolves as follows:

Clause 1 shall be effective from March 1, 2025 (Clause 4).

  1. To approve the attached amendments to be introduced to Resolution of the Government of the Russian Federation dated May 31, 2023, No. 894 “On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means and on the Specifics of Implementing the State Information Monitoring System for the Circulation of Goods Subject to Mandatory Marking with Identification Means in Respect of Certain Types of Medical Devices” (Collection of Legislation of the Russian Federation, 2023, No. 23, Art. 4204; 2024, No. 15, Art. 2031).
  2. To establish that:

 

Until February 28, 2025 (inclusive), participants in the circulation of certain types of medical devices shall be entitled 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 All‑Russian Classifier of Products by Types of 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, 32.50.13.190, 32.50.50.190; codes of the type of medical device 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 Monitoring System for 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 dated May 31, 2023, No. 894 “On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means and on the Specifics of Implementing the State Information Monitoring System for 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 Monitoring System for 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, who are 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 the medical gloves, as specified in paragraph two of this clause, is submitted to the State Information Monitoring System for 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 dated May 31, 2023, No. 894 “On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means and on the Specifics of Implementing the State Information Monitoring System for the Circulation of Goods Subject to Mandatory Marking with Identification Means in Respect of Certain Types of Medical Devices”.

  1. The Ministry of Industry and Trade of the Russian Federation shall conduct an assessment in 2027 of the application of the mandatory requirements introduced by this Resolution.
  2. This Resolution shall enter into force on the date of its official publication, except for Clause 1 of this Resolution, which shall enter into force on March 1, 2025.

 

Chairman of the Government

of the Russian Federation

  1. MISHUSTIN

 

APPROVED

by Resolution of the Government

of the Russian Federation

dated June 26, 2024, No. 860

The amendments approved by Clause 1 shall be effective from March 1, 2025 (Clause 4).

 

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

  1. Clause 3 shall be supplemented with subclauses “e”–“h” of the following content:

“e) Participants in the circulation of certain types of medical devices holding a valid registration certificate for a medical device, who are introducing medical gloves into circulation, shall apply identification means to the consumer packaging, including by applying to such consumer packaging a label containing an identification means for the medical gloves, and shall submit to the monitoring information system information on the application of identification means and the introduction of medical gloves into circulation (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 All‑Russian Classifier of Products by Types of 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; codes of the type of medical device 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, starting 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, starting from March 1, 2025, and information on the circulation of certain types of medical devices in accordance with the Rules approved by this Resolution, starting from September 1, 2025;

“g) Until 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, acquired by February 28, 2025 (inclusive), imported (imported) and released by customs authorities starting from March 1, 2025 under the customs procedure of release for domestic consumption or reimport, prior to offering such medical gloves for sale (sale), shall enter information on the marking of such medical gloves with identification means into the monitoring information system and introduce them into circulation in accordance with the Rules approved by this Resolution;

“h) Participants in the circulation of certain types of medical devices, if, as of March 1, 2025, there are unsold medical gloves specified in subclause “e” of this clause in the territory of the Russian Federation, manufactured in the territory of the Russian Federation or imported into the territory of the Russian Federation by February 28, 2025 (inclusive), shall be entitled, until 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 acquired such medical gloves for activities in the field of healthcare and the provision of social and medical services shall be entitled to store, transport, and transfer such medical gloves free of charge, as provided in the first paragraph of this subclause, without marking with identification means, and to sell (sell) such medical gloves in accordance with the first paragraph of this subclause.

When marking medical gloves with identification means 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, ensure their marking with identification means, and 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 to generate 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.”.”.

  1. In Clause 6:
  2. a) The first paragraph shall be set forth as follows:

“6. It is established that in the territory of the Russian Federation, the introduction into circulation of certain types of medical devices without applying identification means to consumer packaging, including by applying to such consumer packaging a label containing an identification means, for 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 consumer packaging, including by applying to such consumer packaging a label containing an identification means, for such certain types of medical devices and the submission of information to the monitoring information system shall become mandatory, except for the cases specified in the first paragraph of subclause “d” and the first paragraph of subclause “i” of Clause 3 of this Resolution.”;

  1. b) After the words “of the fourth paragraph of subclause “d”, the second paragraph shall be supplemented with the words “and the first paragraph of subclause “i”;
  2. c) In the third paragraph, the words “subclause “g” of Clause 3” shall be replaced with the words “subclauses “g” and “z” of Clause 3”;
  3. d) Supplement with the following paragraph:

“with respect to medical gloves until March 31, 2025 (inclusive).”.

  1. In the Rules for Marking Certain Types of Medical Devices with Identification Means, approved by the said Resolution:
  2. a) Paragraph forty‑seven of Clause 2 shall be set forth as follows:

“Goods” — certain types of medical devices having a valid registration certificate, in part of air disinfectants‑air purifiers (including equipment, bactericidal units, and recirculators used for filtering and purifying air in premises), orthopedic footwear and corrective inlays for orthopedic footwear (including insoles, half‑insoles), hearing aids, except for parts and accessories, coronary stents, computed tomographs, sanitary and hygienic products used for incontinence, medical gloves corresponding to the codes of the Unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union (hereinafter — 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 All‑Russian Classifier of Products by Types of 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 codes of the type of medical device 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;”;

  1. b) Clause 28:

After the fourth paragraph, supplement with the following paragraph:

“Starting 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 medical gloves into circulation and when withdrawing medical gloves from circulation.”

  1. c) Supplement with Clause 41.1 of the following content:

“41.1. In order to register medical gloves in the subsystem of the National Catalog of Marked Goods, the participant in the circulation of goods shall submit the following information about the goods to be registered:

  1. a) the applicant’s taxpayer identification number;
  2. b) the product code (if available);
  3. c) the full name of the product;
  4. d) the trademark (if available);
  5. e) the 10‑digit commodity nomenclature code;
  6. f) the country of origin code in accordance with the All‑Russian Classifier of Countries of the World;
  7. g) the product category;
  8. h) the type of product;
  9. i) the number of consumption units in the consumer packaging;
  10. k) the size of the item;
  11. l) the composition;
  12. m) the registration certificate number for the medical device and the model name of the medical device;
  13. n) the number and date of the declaration of conformity (if available);
  14. o) the shelf life or service life, the number of months (for service life).”
  15. d) In Clause 43, replace the words “in Clauses 37–41” with the words “in Clauses 37–41.1”.
  16. e) In the third paragraph of Clause 44, after the words “and/or 41,”, add the words “and/or 41.1,”.

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