ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of May 31, 2023 No. 894

About approval of Rules of marking of separate types of medical products means of identification and the features of implementation of the state information system of monitoring of turnover of goods which are subject to obligatory marking by means of identification concerning separate types of medical products

The government of the Russian Federation decides:

1. Approve the enclosed Rules of marking of separate types of medical products by means of identification.

2. Determine that participants of turnover of separate types of medical products according to the Rules approved by this resolution:

a) give to the state information system of monitoring of turnover of goods, subject to obligatory marking by means of identification (further - information system of monitoring), the statement on their registration in information system of monitoring since September 1, 2023, but no later than 7 calendar days from the date of emergence of need of implementation by the participant of turnover of separate types of medical products of the activities connected with input in turnover and (or) turnover, and (or) conclusion from turnover of separate types of medical products concerning which the input prohibition in turnover, and (or) turnover, and (or) conclusion from turnover of separate types of medical products not marked by means of identification (except for participants of turnover of separate types of medical products is established, the provisions of Items 3 and 7 of article 2 of the Federal law "About Use of the Control and Cash Equipment when Implementing Calculations in the Russian Federation" falling under action (further - participants of turnover of separate types of medical products in the remote or hardly accessible areas).

At the same time participants of turnover of separate types of medical products in the remote or hardly accessible areas perform registration in information system of monitoring within 30 calendar days from the date of emergence of need of implementation of the activities connected with input in turnover by them and (or) turnover, and (or) conclusion from turnover of separate types of medical products;

b) provide no later than 15 calendar days from the date of registration in information system of monitoring readiness of own software and hardware for information exchange with information system of monitoring and send to the operator of information system of monitoring the request for passing of testing of information exchange electronically;

c) for work on ensuring readiness of own software and hardware for information exchange with information system of monitoring and for passing of testing of information exchange electronically after registration in information system of monitoring send electronically to the operator of information system of monitoring the request for provision of remote access to the issue registration device placed in infrastructure of information system of monitoring;

d) pass test of information exchange of own software and hardware and information system of monitoring according to the procedure posted on the official site of the operator of information system of monitoring on the Internet concerning the transactions connected with marking of separate types of medical products, their input in turnover, turnover and conclusion from turnover according to the Rules approved by this resolution no later than 15 calendar days from the date of readiness of own software and hardware for information exchange with information system of monitoring and the direction of the request according to the subitem "b" of this Item.

3. Determine that:

a) the participants of turnover of separate types of the medical products having the existing registration certificate on medical product, performing input in turnover of separate types of medical products put funds of identification for consumer packaging, including by means of drawing on such consumer packaging of the label containing means of identification, the specified separate types of medical products and represent to information system of monitoring of the data on drawing means of identification and input in turnover of the specified separate types of medical products according to the Rules approved by this resolution:

concerning obezzarazhivatel - air purifiers (including the equipment, the bactericidal installations and retsirkulyator applied to filtering and purification of air in rooms), footwear orthopedic and supplementary corrective elements for footwear orthopedic (including insoles, semi-insoles) (codes of the single Commodity nomenclature of foreign economic activity of the Eurasian Economic Union 842139 200 8, 842139 800 6, 8539 49 000 0, 9018 20 000 0, 902110 100 0, codes of the All-Russian Product Classifier by types of economic activity 28.25.14.110, 32.50.22.150, 32.50.22.151, 32.50.22.152, 32.50.22.155, 32.50.22.156, 32.50.22.157, 32.50.50.190, codes of type of medical product according to nomenclature classification of medical products 131980, 152690, 152700, 182750, 209360, 250220, 250230, 250250, 250260, 292620, 320560, 336330, 343610, 375930) since October 1, 2023;

concerning hearing aids, except parts and accessories, stents of coronary, computer tomographs, sanitary and hygienic products used in case of incontience (codes of the single Commodity nomenclature of foreign economic activity of the Eurasian Economic Union 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 Product Classifier by types of economic activity 17.22.12.130, 26.60.11.111, 26.60.11.113, 26.60.11.119, 26.60.14.120, 32.50.22.190, 32.50.22.195, codes of type of medical product according to nomenclature classification of medical products 113850, 126750, 135190, 135820, 142570, 155760, 155800, 155820, 173110, 202800, 202810, 204370, 210000, 218190, 228560, 233730, 233860, 233900, 273880, 280360, 280730, 282030, 302870, 320550, 331320, 331330, 331830, 343410, 343540, 343580, 356150), since March 1, 2024.

At the same time the participants of turnover of separate types of medical products performing input in turnover of the specified separate types of medical products from the date of entry into force of this resolution have the right to put funds of identification for consumer packaging, including by means of drawing on such consumer packaging of the label containing means of identification, the separate types of medical products specified in paragraphs second and third this subitem on condition of representation in information system of monitoring of data on drawing means of identification and input in turnover of the specified separate types of medical products according to the Rules approved by this resolution and also have the right to represent to information system of monitoring of the data on turnover and conclusion from turnover of separate types of medical products according to the Rules approved by this resolution taking into account requirements of Item 9 of this resolution;

b) participants of turnover of separate types of medical products represent to information system of monitoring according to the Rules approved by this resolution, data on conclusion from turnover of separate types of medical products since September 1, 2024, data on turnover of separate types of medical products (except for the sanitary and hygienic products used in case of incontience) according to the Rules approved by this resolution since September 1, 2025, data on turnover of the sanitary and hygienic products used in case of incontience according to the Rules approved by this resolution since March 1, 2026.

At the same time participants of turnover of separate types of medical products have the right to represent to information system of monitoring of the data on turnover and conclusion from turnover of separate types of medical products according to the Rules approved by this resolution from the date of entry into force of this resolution;

c) participants of turnover of separate types of medical products in the remote or hardly accessible areas have the right to represent the data specified in the Section VIII of the Rules approved by this resolution within 30 calendar days:

from the date of shipment (transfer or acceptance) separate types of medical products by transfer (acceptance) of separate types of medical products within the transactions providing transition of the property right to the specified goods and also within commission agreements, and (or) agency agreements, and (or) works agreements, and (or) agreements of the order;

from the date of conclusion of separate types of medical products from turnover in case of conclusion of separate types of medical products from turnover;

from the date of return of separate types of medical products to turnover in case of such return;

from the date of change of the data provided by Sections III, IV, VIII and IX of the Rules approved by this resolution in case of change of such data;

d) participants of turnover of separate types of medical products perform marking of the separate types of the medical products imported (imported) and placed under customs procedures of release for internal consumption or reimport to the offer of these separate types of medical products for realization (sale) and enter into information system of monitoring of the data on marking of such separate types of medical products means of identification according to the Rules approved by this resolution:

concerning obezzarazhivatel - air purifiers (including the equipment, the bactericidal installations and retsirkulyator applied to filtering and purification of air in rooms), footwear orthopedic and supplementary corrective elements for footwear orthopedic (including insoles, semi-insoles), acquired till September 30, 2023 (inclusive) and issued by customs authorities since October 1, 2023 till October 31, 2023 (inclusive);

concerning hearing aids, except parts and accessories, stents of the coronary, computer tomographs, sanitary and hygienic products used in case of incontience, acquired till February 29, 2024 (inclusive) and issued by customs authorities since March 1, 2024 till March 31, 2024 (inclusive);

e) participants of turnover of separate types of medical products in the presence of in the territory of the Russian Federation unrealized separate types of medical products have the right to enable the realization of such medical products not marked means of identification before the expiration of their validity (except for separate types of the medical products having service life) or to perform marking by means of identification of such medical products and to represent data on marking of separate types of medical products means of identification to information system of monitoring according to the Rules approved by this resolution till August 31, 2024 (inclusive):

concerning obezzarazhivatel - air purifiers (including the equipment, the bactericidal installations and retsirkulyator applied to filtering and purification of air in rooms), footwear orthopedic and supplementary corrective elements for footwear orthopedic (including insoles, floor of insoles), introduced into circulation till September 30, 2023 (inclusive) and not implemented as of October 1, 2023;

concerning hearing aids, except parts and accessories, stents of the coronary, computer tomographs, sanitary and hygienic products used in case of incontience, introduced into circulation till February 29, 2024 (inclusive) and which are not realized as of March 1, 2024.

Participants of turnover of separate types of the medical products having service life in the presence of in the territory of the Russian Federation such unrealized separate types of medical products have the right to enable the realization of such medical products not marked means of identification or to perform their marking by means of identification and to represent data on marking of such separate types of medical products means of identification to information system of monitoring according to the Rules approved by this resolution till August 31, 2024 (inclusive):

concerning obezzarazhivatel - air purifiers (including the equipment, the bactericidal installations and retsirkulyator applied to filtering and purification of air in rooms), footwear orthopedic and supplementary corrective elements for footwear orthopedic (including insoles, floor of insoles), introduced into circulation till September 30, 2023 (inclusive) and not implemented as of October 1, 2023;

concerning hearing aids, except parts and accessories, stents of the coronary, computer tomographs, sanitary and hygienic products used in case of incontience, introduced into circulation till February 29, 2024 (inclusive) and which are not realized as of March 1, 2024.

At the same time participants of turnover of separate types of the medical products having service life who acquired such medical products for implementation of activities in the field of health care and rendering social and medical services had the right to perform storage, transportation and voluntary conveyance of such medical products provided by paragraphs the fifth and sixth this subitem, not marked means of identification and realization (sale) of such medical products according to the paragraph the fourth this Item.

In cases, the specified in paragraphs one and (or) the fourth this subitem, the participant of turnover of separate types of medical products registers such medical products in subsystem of the national catalog of the marked goods of information system of monitoring and specifies the data provided by Items 37 - 41 Rules approved by this resolution provides their marking, and also represents data on their marking by means of identification to information system of monitoring according to the Rules approved by this resolution.

Payment of the codes of marking necessary for forming of means of identification of separate types of medical products, the specified in paragraphs one and the fourth this subitem, is performed according to the Rules approved by this resolution;

e) the participants of turnover of separate types of the medical products having the existing registration certificate on medical product, performing input in turnover of gloves medical put funds of identification for consumer packaging, including by means of drawing on such consumer packaging of the label containing means of identification, gloves medical and represent to information system of monitoring of the data on drawing means of identification and input in turnover of gloves medical (codes of the single 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 Product Classifier 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 type of medical product according to nomenclature classification of medical products 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) according to the Rules approved by this resolution since March 1, 2025;

g) participants of turnover of separate types of medical products represent to information system of monitoring according to the Rules approved by this resolution, data on conclusion from turnover of separate types of the medical products specified in the subitem "e" of this Item since March 1, 2025, data on turnover of separate types of medical products according to the Rules approved by this resolution since March 1, 2026;

h) till March 31, 2025 (inclusive) participants of turnover of separate types of medical products perform marking of gloves medical, specified in the subitem "e" of this Item, acquired till February 28, 2025 (inclusive), imported (imported) and issued by customs authorities since March 1, 2025 according to customs procedure of release for internal consumption or reimport, to the offer of such gloves medical for realization (sale), enter into information system of monitoring of the data on marking of such gloves medical means of identification and introduce them into circulation according to the Rules approved by this resolution;

i) participants of turnover of separate types of medical products in the presence as of March 1, 2025 in the territory of the Russian Federation unrealized gloves medical, specified in the subitem "e" of this Item, made in the territory of the Russian Federation or imported on the territory of the Russian Federation till the February 28, 2025 (inclusive) having the right to enable (inclusive) till August 31, 2025 the realization of such gloves medical not marked means of identification or to perform marking by means of identification of such gloves medical and to represent data on marking by means of identification to information system of monitoring according to the Rules approved by this resolution.

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