Mandatory labelling requirements for medical devices

In September 2023, the Russian Federation began the gradual implementation of rules for mandatory labeling of medical devices with an additional identification means “Chestny Znak” (hereinafter referred to as “CZ”).

The CZ label is a special Data Matrix code, which is applied (indicated on the original label or as a separate label) to the packaging (consumer, group, set).

Picture 1 – DataMatrix code example

The label code stores the following information:

 1) 14-digit GTIN product code;

 2) Individual 13-character serial number;

 3) Verification code, which ensures verification of the originality of the label code.

By recording the progress of the MD at each tracked stage of the MD life cycle, the Chestny Znak system eliminates the appearance of duplicates of the product and the possibility of re-introducing MD to the market, including those with an expired shelf life.

The rules for using the CZ are regulated by the Decree of the Government of the Russian Federation No. 894 of May 31, 2023 "On approval of the Rules for labeling certain types of medical devices with identification means and the specifics of implementing the state information system for monitoring the circulation of goods subject to mandatory labeling with identification means in relation to certain types of medical devices" (came into force on September 1, 2023; hereinafter referred to as "the Russian Federation Government Decree No. 894").

The Russian Federation Government Decree No. 894 also contains the requirements for:

·         participants in the circulation of medical devices with the CZ;

·         procedure for the exchange of information between participants in the circulation of medical devices and the state information system for monitoring the circulation of goods with the CZ (hereinafter referred to as the “Information Monitoring System”);

·         characteristics of the CZ;

·         procedure for submitting the data to the information monitoring system by participants in the circulation of medical devices with the CZ on the introduction into circulation, circulation and withdrawal from circulation of medical devices with the Chestnyi Znak.

Participants in the circulation of medical devices with CZ are legal entities engaged in the sale of MD in the domestic market of Russia, such as importers of foreign MD, manufacturers within Russia, sellers, and other legal entities that transmit information about the sale of a unit of goods with CZ through electronic document management.

In accordance with the Russian Federation Government Decree No. 894 the following stages and deadlines for the introduction of mandatory labeling of CZ are established

●                  Starting from September 1, 2023 – registration of participants in the circulation in the labeling system is possible.

●                  From October 1, 2023 – labeling becomes mandatory for the following "categories" of medical devices:

○       "disinfectants" - air purifiers;

○       orthopedic shoes and corrective insoles for orthopedic shoes.

●                  From March 1, 2024 – labeling becomes mandatory for other types of medical devices subject to mandatory labeling.

●                  From March 1, 2025 – labeling becomes mandatory for the category of medical devices: medical gloves.

It should be noted that the issuance of a customs import declaration in Russia under the procedure for release for domestic consumption (import 40)[1] is not possible without applying CZ to each unit of goods (subject to mandatory labeling).

Currently, the following methods of applying CZ to MD are known:

1.                 Application of CZ labeling in the territory of the customs warehouse, that is, placing the goods under the customs warehouse procedure (IМ 70)^[2]. The responsibility for applying CZ to each unit of goods lies with the importer, that is, the buyer of foreign MD, who must be registered in the CZ system and have the necessary equipment for applying CZ.

2. Application of CZ labeling in the territory of the manufacturing country, by transferring the necessary equipment for applying CZ labeling (for example, a printer for printing labels, corresponding software), connected to the CZ system via the internet, by a legal entity from Russia registered in the CZ system. This equipment is transferred to the foreign manufacturer under the customs procedure of temporary export (EC23)^[3]. That is, a legal entity from Russia (the importer) purchasing MD from a foreign manufacturer under a registration certificate must be registered in the CZ system and bring the equipment for applying CZ to the manufacturer, connecting it to the CZ system via the internet. The foreign manufacturer cannot register independently in the Chestnyi Znak system, as only legal entities from Russia can register in it.

The products subject to labeling

Deadlines for the introduction of mandatory labeling of CZ	Name of the product group	EAEU TN VED Code[4]	OKPD2 code[5] and its correspondence to the code of the type of medical device in accordance with the nomenclature classification of medical devices[6]	Note
from October 1, 2023	Air disinfection and purification devices (including equipment, bactericidal installations and recirculators used for filtering and cleaning air in rooms)	8421 39 200 8 8421 39 800 6 8539 49 000 0 9018 20 000 0	OKPD2: 28.25.14.110   List of type codes: 131980, 152690, 152700, 182750, 209360, 292620, 336330	The goods are subject to labeling only if they fall under both the TN VED code and the OKPD2 code. When identifying medical devices subject to mandatory labeling, in addition to the specified TN VED and OKPD2 codes, one should also be guided by the name of the type of medical device and the code of the type of medical device in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of the Russian Federation. The goods are not subject to labeling at this stage in the following cases: Medical devices made by individual order of the patient (such products are not subject to state registration, do not have a valid registration certificate for a medical device and, therefore, are not subject to mandatory labeling) Checking the need to apply the CZ on the device, taking into account the TN VED code and the OKPD2 code, is carried out on the official website Chestnyznak.rf  https://xn--80ajghhoc2aj1c8b.xn--p1ai/checking_codes/.   The type code, as well as the OKPD 2 code, are indicated in the registration certificate for the medical device. This data can also be found in the registry entry on the Roszdravnadzor website using the service “State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Production and Manufacturing of Medical Devices”. It is necessary to take into account the data specified in the registration certificate for the medical device when determining the need to apply the CZ. The data in the table is provided for reference.https://roszdravnadzor.gov.ru/services/misearch. The TN VED code is determined by the declarant when filing a customs declaration in Russia, but can be adjusted by the Customs authorities of the Russian Federation during the review of the customs declaration before its release. The TN VED code is not identical to the CZ code, which is used abroad. You can familiarize yourself with the commodity nomenclature of foreign economic activity using the online service https://www.alta.ru/tnved/.
			OKPD2: 32.50.50.190 List of type codes: 131980, 152690, 152700, 182750, 209360, 292620, 336330
	Orthopedic footwear and insertable corrective elements for orthopedic footwear (including insoles, half-insoles)	9021 10 100 0	OKPD2: 32.50.22.150-…157   List of type codes: 250220, 250230, 250250, 250260, 320560, 320560, 343610
from March 1, 2024	Hearing aids, excluding parts and accessories	9021 40 000 0	OKPD2: 26.60.14.120   List of type codes: 113850; 173110; 202800; 202810; 204370; 210000; 228560; 302870
	Coronary stents	9021 90 900 1	OKPD2: 32.50.22.190   List of type codes: 135820, 155760, 155800, 155820, 218190, 273880, 343410, 343540
			OKPD2: 32.50.22.195   List of type codes: 135820, 155760, 155800, 155820, 218190, 273880, 343410, 343540
	Computer tomograpCZ	9022 12 000 0; 9022 13 000 0; 9022 14 000 0; 9022 19 000 0	OKPD2: 26.60.11.111   List of type codes: 135190, 142570, 280730, 282030
			OKPD2: 26.60.11.113   List of type codes: 135190, 142570, 280730, 282030
			OKPD2: 26.60.11.119   List of type codes: 135190, 142570, 280730, 282030
	Sanitary and hygienic devices used for incontinence	9619 00 890	OKPD2: 17.22.12.130   List of type codes: 233730; 233900; 280360; 320550; 331320; 331330; 331830; 356150
from March 1, 2024	Medical gloves	3926 20 000 0; 4015 12 000 1; 4015 12 000 9; 4015 19 000 0	OKPD2: 14.12.30.160   List of type codes: 130220
		4015 12 000 1	OKPD2: 22.19.60.111   List of type codes: 122630, 122640, 129800, 129900, 139310, 156530, 185700, 185720, 201590, 201600, 201610, 316120, 322780, 323740, 323740, 326340
		4015 12 000 1	OKPD2: 22.19.60.113   List of type codes: 122630, 122640, 129800, 323740, 323740, 326340,
		4015 12 000 9	OKPD2: 22.19.60.119   List of type codes: 122540, 122560, 122610, 139350, 139360, 185830, 185850, 298450, 311720, 320790, 321530, 329770, 349230, 351490
		4015 19 000 0	OKPD2: 22.19.71.190   List of type codes: 122540, 122560, 122610, 185830
		3926 20 000 0	OKPD2: 22.29.10.120   List of type codes: 205280, 205290, 388560
		3926 20 000 0; 4015 12 000 1; 4015 19 000 0; 4015 12 000 9	OKPD2: 32.50.13.190   List of type codes: 169840, 257300, 318420
		3926 20 000 0; 4015 12 000 1; 4015 19 000 0; 4015 12 000 9	OKPD2: 32.50.50.190   List of type codes: 130220, 169840, 257300, 318420

 Additional notes: 

1.      The Russian Federation Government Decree No. 894 regulates the application of the CZ on medical devices that have a valid registration certificate.

2. It is not required to undergo the procedure of making amendments of the documents contained in the registration dossier of the medical device in order to indicate in the registration dossier documents information on the application of the mandatory CZ label on the MD from the list.

3. The application of the mandatory “Chestny Znak” label on the registered MD does not exempt the manufacturer from the need to apply label on the MD according to the layout approved by Roszdravnadzor during the registration of this medical device. The MD label must fully comply with the documents of the MD registration dossier, including the file with photographic images of the MD and operational documentation, which can be viewed on the Roszdravnadzor website through the service “State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Production and Manufacture of Medical Devices”https://roszdravnadzor.gov.ru/services/misearch.