Labeling · Issue No. 2, 2023

E. Zhavoronkov. Labeling of Medical Devices with "Chestny Znak": What Is Important to Know

Abbreviations and terms used in this publication

• "Chestny Znak" is the state information system for monitoring the circulation of goods (GIS MT)
• EDM is electronic document management
• UTD is a universal transfer document. The Federal Tax Service of Russia, in its letter of 21.10.2013 No. MMV-20-3/96@ "On the Absence of Tax Risks When Taxpayers Use a Primary Document Drawn Up on the Basis of an Invoice", provides the form of the universal transfer document
• "Importer": the definition of an importer is given in RF Government Decree of 31.05.2023 No. 894. It is a legal entity, a branch of a foreign legal entity or a sole proprietor that imports goods into the Russian Federation, except for cases of transit of such goods through the territory of the Russian Federation
• Putting goods into circulation in accordance with RF Government Decree of 31.05.2023 No. 894
• Withdrawing goods from circulation in accordance with RF Government Decree of 31.05.2023 No. 894

On 31 May 2023, the Government signed a decree that establishes the rules for labeling certain types of medical devices with unique means of identification.

• Which goods will be subject to labeling?
• What are the implementation deadlines, and what steps must each participant in circulation take?

This article gives answers to these and other questions on the labeling of medical devices.

Regulatory framework for labeling medical devices with means of identification

RF Government Decree of 09.02.2022 No. 137
"On Conducting an Experiment in the Territory of the Russian Federation on Labeling Certain Types of Medical Devices with Means of Identification".

Period of the experiment: 15 February 2022 – 28 February 2023

RF Government Decree of 31.05.2023 No. 894
"On Approval of the Rules for Labeling Certain Types of Medical Devices with Means of Identification and on the Specifics of Introducing the State Information System for Monitoring the Circulation of Goods Subject to Mandatory Labeling with Means of Identification in Respect of Certain Types of Medical Devices".

Effective date: from 1 September 2023

RF Government Order of 28.04.2018 No. 792-r
"On Approval of the List of Certain Goods Subject to Mandatory Labeling with Means of Identification" (as amended on 31.05.2023 No. 1439).

What "Chestny Znak" labeling is: a brief overview

"Chestny Znak" is a state system of digital labeling and traceability of goods, launched in 2019.

The main task of the system is to improve the safety of Russians and to fight counterfeit and substandard analogues.

Data Matrix is a unique digital labeling code that consists of two parts: an identification code, which determines the position of the product in the system and in the unified product catalog,
and a verification code, or crypto tail, which is generated by the operator using domestic cryptography technologies.

The "Chestny Znak" state labeling system: benefits for everyone

For the consumer:

• Confidence in buying legal, high-quality goods
• Protection of life and health
• A tool for public oversight and protection of consumer rights
• Product data, including permitting documentation and origin
• Information on the state of the markets
• All the effects of using data in government and business
• Prevention of shortages and unjustified price increases

For business:

• Revenue growth and greater competitiveness of the "white" (legitimate) business
• Process optimization and lower costs
• Access to data on the movement of products along the logistics chain
• Analytical products for business

For the state:

• A smaller "gray" market and higher labor productivity
• Higher tax and customs revenues
• Budget savings on controlling commodity markets
• Complete analytics on the state of the markets
• Data for the strategic development of industries
• Risk and violation management systems

Circulation scheme for labeled medical devices

All participants in circulation must be registered in the labeling system.

1. Manufacturers and importers physically apply labeling codes to their medical devices
and submit to the labeling system
(the state information system for monitoring the circulation of goods, GIS MT) information
on the application of labeling codes to a specific batch and a specific medical device.

2. Next, wholesale and retail sellers and distributors take part in the labeling system and in circulation.
They purchase medical devices labeled by manufacturers and importers.

It is important to bear in mind that information on circulation will come into the labeling system from EDM operators, which means that labeled medical devices will circulate only through EDM by means of the UTD.

3. Then the store sells the labeled medical device.
At the time of sale, the labeling code must be scanned at the cash register, and the fiscal data operator sends to the labeling system the information that a specific medical device has been withdrawn from circulation*.

During the experiment, the regulators decided that treatment and treatment-and-social care institutions (public and private hospitals, nursing homes, and so on) that purchase certain types of medical devices
and provide them to their patients must also be participants in the circulation of labeled medical devices. For such institutions, withdrawal from circulation means writing off the medical device or sending it for disposal.

4. By scanning the labeling code on a medical device, the consumer will be able to see information about that medical device in the Chestny ZNAK app
(the date, place of production and sale, the brand).
That is, the buyer will have access to the information about the medical device that was entered into GIS MT
by the participants in circulation.

Stages of introducing mandatory labeling of medical devices

The stages are the connection of different types of participants to mandatory labeling on different dates (Figure 1).

STAGE 1: 1 September 2023

From this date, mandatory registration in the labeling system begins.
During this month, participants in circulation must:

• register in the system
• describe product cards, indicating the numbers of the registration certificates obtained from Roszdravnadzor (relevant for manufacturers and importers)
• sign documents with CRPT, the operator of the labeling system

STAGE 2: 1 October 2023

From this date, labeling codes become paid.

The fee for providing labeling codes, as well as the procedure for collecting it, is set out in RF Government Decree of 08.05.2019 No. 577.

At this stage there is one special feature for medical devices: the obligation to apply labeling is divided into 2 groups (Table 2).

Table 2

The 1st group includes air disinfectors, orthopedic footwear and insoles.

• These types of medical devices start to be labeled on 1 October 2023.
• All the other types of medical devices named in the decree (coronary stents, computed tomography scanners, sanitary and hygienic products, hearing aids) start to be labeled on a mandatory basis on 1 March 2024.

If participants in the circulation of second-group medical devices work in the GIS MT labeling system from 1 October 2023 in order to test various technological solutions, the labeling codes will already be paid for them, but the obligation to apply them does not yet apply.

STAGE 3: 1 September 2024

For all participants in circulation, mandatory submission of information to the labeling system on the withdrawal of goods from circulation begins.

• At this stage, all retail stores and all treatment and treatment-and-social care institutions are connected. They become obliged to enter into the labeling system the information on the withdrawal of a medical device from circulation. For retail stores, withdrawal is carried out through cash register equipment, and for treatment and treatment-and-social care institutions, directly in the labeling system.

STAGE 4: 1 September 2025

From this date, mandatory item-by-item accounting in the UTD begins.

• The accounting requirement applies to wholesale sellers, and all participants in circulation start working with electronic document management and including in the UTD the labeling codes, which they pass on together with their goods to their buyers.

From this date, the labeling system will begin to collect information on all circulation chains of labeled medical devices and on the volumes of goods produced.

Volume-and-assortment accounting is not provided for medical devices. For them, item-by-item traceability starts right away, but it begins after 2 years. This deferred deadline gives time to prepare for item-by-item accounting.

Labeling of remaining stock

Remaining stock includes medical devices that were produced or imported before the requirements on the mandatory application of labeling codes took effect.

Medical devices subject to labeling are divided into two categories by term:

1. With a service life
2. With a shelf life

It was decided that the remaining stock of medical devices that have a service life must be labeled, except for medical devices that are already installed in treatment and treatment-and-social care institutions.
Thus, the remaining stock of medical devices held in warehouses by manufacturers, by importers, and by wholesale and retail sellers must be labeled by 31 August 2024.

For all other medical devices, which have a shelf life, there is a choice.

They can be sold off before the expiry of the shelf life, or they can be labeled.

There is a limit on labeling all remaining stock, both with a service life and with a shelf life.

• Remaining stock can be labeled from 1 October 2023 to 31 August 2024.
• During this period, participants in the circulation of devices with a shelf life will have to decide whether or not to label their remaining stock.
• Participants in the circulation of medical devices with a service life will be required to label their remaining stock.

Since there are several participants in circulation and each has its own specifics of introducing labeling,

the steps for each participant are described below:
what needs to be done before the requirements on mandatory labeling take effect.

Russian manufacturers: preparing for labeling

STEP 1. By 1 October 2023, manufacturers whose production is located in the territory of the Russian Federation must complete mandatory registration in GIS MT.

STEP 2. It is necessary to choose a technology partner, with whom the company will organize the labeling process at its enterprise, or labeling can be applied independently by the company's own specialists.

STEP 3. By 1 October 2023, without fail.

It is required to register product cards online in GIS MT, indicating the numbers of the registration certificates obtained from Roszdravnadzor.

Because the product card contains the registration certificate number and the model of the medical device, some manufacturers run into difficulties here, since these data are added to the labeling system from the Ministry of Health's system of regulatory reference information (FRNSI). The Ministry of Health, in turn, receives these data from the Roszdravnadzor register.

Accordingly, when creating a product card in GIS MT, difficulties arise when manufacturers or importers cannot find the number of their registration certificate or the model registered under that number.

If the registration certificate number and the model of the medical device are missing
in GIS MT, you need to:

Send a message by e-mail to the Roszdravnadzor support service (rzn_support@ppr.ru).

1. Roszdravnadzor will make changes to its register
2. Then, down the chain, changes will be made to the Ministry of Health's reference directory
3. After that, the up-to-date data will appear in the labeling system

This process takes some time, so it is better to start registering product cards in advance.

STEP 4. By 1 October 2023, you must conclude an agreement with the operator of "Chestny Znak", CRPT. The agreement will be in the organization's personal account after registration in GIS MT.

• You will need to review the documents and sign them with an enhanced qualified electronic signature.
• The agreement will become available between August and September 2023.

STEP 5. Installing labeling equipment and software.

• For Group 1, the deadline is 1 October
• For Group 2, the deadline is 1 March 2024

Because these are the dates when the application of labeling codes becomes mandatory.

From 1 September 2025, circulation is mandatory.

Therefore you need to prepare:

• the inventory accounting system, in terms of integration with GIS MT and the EDM Operator
• equipment for aggregating and scanning labeling codes

Before that date, it is recommended to debug the receipt and transfer of batches of medical devices within EDM.

Importers: preparing for labeling

STEP 1. By 1 October 2023, importers must complete mandatory registration in GIS MT.

STEP 2. You need to decide where the devices will be labeled.

• customs warehouse
• logistics warehouse
• temporary storage warehouse
• foreign production site

Based on the decision made, the importer will need to select technology partners:

• companies that provide services at a customs warehouse, at a temporary storage warehouse, at a logistics warehouse.

Or importers will need to agree with their foreign production site that labeling will take place there.

Accordingly, it will be necessary to determine how the unique labeling codes will be transferred to these warehouses or foreign production sites. This is not a quick process, so it is recommended to start working on it in advance.

For the 1st group of medical devices, readiness must be ensured by 1 October 2023.
For the second group of medical devices, by 1 March 2024.

STEP 3. By 1 October 2023, without fail, it is required to register product cards in GIS MT. This step is the same as the manufacturer's actions and is described in more detail above.

STEP 4. By 1 October 2023, you must conclude an agreement with the operator of "Chestny Znak", CRPT. The agreement will be in the organization's personal account after registration in GIS MT.

• You will need to review the documents and sign them with an enhanced qualified electronic signature.
• The agreement will become available between August and September 2023.

STEP 5. By 1 September 2025, it is required to:

• prepare the inventory accounting system, in terms of integration with GIS MT and the EDM Operator.
• prepare equipment for aggregating and scanning labeling codes.

Wholesale and retail sellers: preparing for labeling

STEP 1. By 1 October 2023, wholesale and retail sellers must complete mandatory registration in GIS MT.

STEP 2. By 1 October 2023, you must conclude an agreement with the operator of "Chestny Znak", CRPT. The agreement will be in the organization's personal account after registration in GIS MT.

• You will need to review the documents and sign them with an enhanced qualified electronic signature.
• The agreement will become available between August and September 2023.

STEP 3. By 1 September 2024, you need to prepare cash register equipment and scanning equipment.

From this date, the withdrawal of labeled medical devices from circulation becomes mandatory.

STEP 4. By 1 September 2025, you are required to prepare

• the inventory accounting system, in terms of integration with GIS MT and the EDM Operator.
• equipment for aggregating labeling codes.

Treatment and treatment-and-social care institutions: preparing for labeling

STEP 1. By 1 October 2023, treatment and treatment-and-social care institutions must complete mandatory registration in GIS MT.

STEP 2. By 1 October 2023, you must conclude an agreement with the operator of "Chestny Znak"

• You will need to review the documents and sign them with an enhanced qualified electronic signature.
• The agreement will become available between August and September 2023.

STEP 3. By 1 September 2024, you need to:

• prepare the inventory accounting system, in terms of integration with GIS MT.
• prepare equipment for aggregating and scanning labeling codes.

From this date, the withdrawal of labeled medical devices from circulation becomes mandatory.

STEP 4. By 1 September 2025, you are required to prepare

• the inventory accounting system, in terms of integration with the EDM Operator.

Liability for violating the rules of labeling with means of identification

The labeling of goods is regulated at the level of legislation. Violation of the established rules and requirements is punished under administrative and criminal law in accordance with Article 15.12 of the Code of Administrative Offenses of the Russian Federation and Article 171.1 of the Criminal Code of the Russian Federation.

Standardization in the field of biological safety research of medical devices (toxicology)

The National Technical Committee for Standardization (TC 422) and the Interstate Technical Committee for Standardization (MTC 547)
"Biological Evaluation of Medical Devices" are

a voluntary association of

• interested enterprises, scientific organizations and federal government bodies, formed to carry out work on national, interstate and international standardization in the sphere of the circulation of medical devices

The secretariats of the technical committees "Biological Evaluation of Medical Devices" are based at the autonomous non-profit organization "Institute of Biomedical Research and Technologies" (ANO "IMBIIT"),

• which provides funding
• as well as material and organizational support for their work

The main goal of TC 422's work is:

• to develop documents that establish requirements for protecting the human body against the biological risk associated with the use of medical devices.

Standards put into effect in 2023:

• GOST 34901-2022 Medical devices. System for biological evaluation. General requirements for conducting studies (tests)
• GOST ISO 10993-18-2022 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials within a risk management process
• GOST ISO 10993-9-2022 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

Standards planned to be put into effect in 2024:

• GOST ISO 10993-5 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
• GOST ISO 10993-10 Medical devices. Biological evaluation of medical devices. Part 10. Tests for skin sensitization
• GOST ISO 10993-12 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
• GOST ISO 10993-15 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
• GOST ISO 10993-23 Medical devices. Biological evaluation of medical devices. Part 23. Tests for irritation
• GOST R 52770 Medical devices. System for biological evaluation. General safety requirements

In 2023–2024, draft interstate standards are being developed on the following topics:

• GOST ISO 10993-19 Medical devices. Biological evaluation of medical devices. Part 19. Physico-chemical, morphological and topographical characterization of materials
• GOST ISO/TS 37137-1 Medical devices. Biological evaluation of absorbable medical devices. Part 1. General requirements
• GOST ISO/TR 21582 Medical devices. Biological evaluation of medical devices. Pyrogenicity. Principles and methods for pyrogenicity testing of medical devices

Author of the article: Egor Zhavoronkov

Other articles · Issue No. 2, 2023