Medical Device Marking in Russia 2026. Hearing Aids, Stents and CT Scanners in Chestny ZNAK
Since September 2025, the medical device market has operated under a different regime. Hearing aids, coronary stents, and computed tomography (CT) scanners are tracked on an item-by-item basis in the State Information System for Monitoring Goods Turnover (GIS MT). Every transfer from a manufacturer to a distributor, or from a warehouse to a healthcare organization, is accompanied by an electronic document containing unique identification codes.
Starting March 1, 2026, sanitary and hygienic incontinence products joined these categories. Adult diapers and urological pads transitioned to the same item-by-item accounting regime.
For healthcare organizations, distributors, and importers, this means one thing: accepting goods without marking or without a valid electronic document is no longer permitted. This guide covers who is affected, how to register in the Chestny ZNAK system, and what to do right now.
Why the State Took Control of Medical Devices
Until 2023, the medical device market operated without end-to-end traceability. A manufacturer or importer released a product, a distributor delivered it to warehouses, and a medical institution purchased a batch. Documentation was maintained at each stage, but there was no link between the nodes in the supply chain.
This gave rise to several systemic problems. According to Roszdravnadzor (the Federal Service for Surveillance in Healthcare), between 50 and 100 cases of counterfeit implantable devices were detected annually, with falsified stents finding their way into operating rooms. Hearing aids issued to persons with disabilities under social support programs resurfaced on the secondary market. Expensive CT scanners sat idle in some hospitals while others waited months to procure them.
The state had no visibility into actual consumption. Procurement was planned on the basis of applications rather than real usage data. Budget funds financed equipment that then sat in warehouses for months on end.
With the introduction of marking, each device received a digital passport. The regulator now sees the product’s journey from the factory to the patient.
Three Waves and What Fell Under Marking
Government Decree No. 894 dated May 31, 2023, «On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means» (hereinafter Decree No. 894), divided medical devices into groups based on implementation deadlines.
The First Wave (from October 1, 2023):
Air disinfection and purification units (recirculators, bactericidal units)
Orthopedic shoes and insoles
The Second Wave (from March 1, 2024):
Hearing aids (excluding parts and accessories)
Coronary stents
Computed tomography (CT) scanners
Sanitary and hygienic incontinence products (adult diapers, urological pads
The Third Wave (from March 1, 2025):
Medical gloves
Whether a specific device must be marked is determined by three parameters simultaneously: the HS Code (TN VED EAEU), the OKPD 2 code, and the medical device (MD) type code according to the nomenclature classification. If all three codes match those listed in Decree No. 894, the device is subject to mandatory marking.
Codes for Hearing Aids
| Parameter | Value |
|---|---|
| HS Code (TN VED EAEU) | 9021 40 000 0 |
| OKPD 2 | 26.60.14.120 |
| MD Type Codes | 113850, 173110, 202800, 202810, 204370, 210000, 228560, 302870 |
Codes for Coronary Stents
| Parameter | Value |
|---|---|
| HS Code (TN VED EAEU) | 9021 90 900 1 |
| OKPD 2 | 32.50.22.190, 32.50.22.195 |
| MD Type Codes | 135820, 155760, 155800, 155820, 218190, 273880, 343410, 343540 |
Codes for CT Scanners
| Parameter | Value |
|---|---|
| HS Code (TN VED EAEU) | 9022 12 000 0, 9022 13 000 0, 9022 14 000 0, 9022 19 000 0 |
| OKPD 2 | 26.60.11.111, 26.60.11.113, 26.60.11.119 |
| MD Type Codes | 135190, 142570, 280730, 282030 |
Codes for Sanitary and Hygienic Incontinence Products
| Parameter | Value |
|---|---|
| HS Code (TN VED EAEU) | 9619 00 890 |
| OKPD 2 | 17.22.12.130 |
| MD Type Codes | 126750, 233730, 233860, 233900, 280360, 320550, 331320, 331330, 331830, 343580, 356150 |
The device must hold a valid Registration Certificate (RC). Without an RC, marking is technically impossible: the RC number is part of the mandatory data required to register a product in the Chestny ZNAK system catalog.
How Requirements Evolved After the Launch
The system for second-wave devices was rolled out in phases:
| Date | Event |
|---|---|
| September 1, 2023 | Registration of turnover participants in GIS MT opens |
| March 1, 2024 | Mandatory application of marking codes upon introduction into turnover |
| April 1, 2024 | Importers required to mark goods before customs declaration |
| September 1, 2024 | Mandatory submission of data on withdrawal from turnover |
| September 1, 2024 | Deadline for marking remaining stock with a designated service life |
| September 1, 2025 | Mandatory item-by-item accounting via EDI (hearing aids, stents, CT scanners) |
| March 1, 2026 | Mandatory item-by-item accounting via EDI (sanitary and hygienic products) |
As of September 1, 2025, simply applying a code to the packaging and reporting its introduction into turnover is no longer sufficient. Every transfer of hearing aids, stents, and CT scanners between turnover participants must be accompanied by a Universal Transfer Document (UTD) listing the marking codes. These documents are transmitted to the Chestny ZNAK system via an Electronic Document Management (EDM) operator.
For sanitary-hygienic products and medical gloves, the mandatory EDM deadline was deferred to March 1, 2026, by Government Decree No. 1409 dated September 12, 2025.
Who Qualifies as a Turnover Participant
Marking requirements apply to all organizations in the supply chain, from production to the final consumer:
Manufacturers apply codes to the packaging, introduce goods into turnover, and submit data to GIS MT.
Importers mark goods before or after customs clearance (depending on the contract date) and introduce them into turnover after customs release.
Distributors and wholesalers accept goods with code verification, pass them further down the chain, and record all operations via EDM.
Healthcare organizations accept marked devices and withdraw them from turnover when used to provide medical care.
Pharmacy organizations accept goods, sell them at the cash register, and record disposal through a fiscal data operator.
Healthcare organizations that acquire devices for their own needs (patient treatment) are also considered turnover participants. They are required to register in the Chestny ZNAK system and confirm receipt of goods via EDM.
What a Marking Code Is
A marking code is a unique sequence of characters applied to the packaging in the form of a two-dimensional Data Matrix barcode. The code consists of four groups:
AI = 01: A 14-digit Global Trade Item Number (GTIN) identifying the product name.
AI = 21: A 13-character individual serial number. The first character denotes the country issuing the code («5» for Russia); the remaining 12 characters uniquely identify the specific unit.
AI = 91: A 4-character verification key identifier.
AI = 92: A 44-character verification code formed via cryptographic transformation.
The first and second groups form the Identification Code (IC), used to track the product in the system. The third and fourth groups protect against counterfeiting: upon scanning, the code is verified through a cryptographic mechanism.
The Data Matrix code must comply with GOST R ISO/IEC 16022-2008. Print quality must not fall below grade 1.5 (C) per GOST R ISO/IEC 15415-2012. The module size ranges from 0.255 to 0.680 millimeters.
How Much Marking Costs
The Chestny ZNAK system operator, the Center for Advanced Technologies (CRPT), charges a fee for providing marking codes under Government Decree No. 577 dated May 8, 2019.
A single code costs 50 kopecks excluding VAT (60 kopecks including VAT). For large volumes, the total adds up quickly: a batch of 100,000 adult diapers costs 60,000 rubles in codes alone.
In addition to code fees, participants bear costs for:
Upgrading production lines or procuring code application equipment
Scanners for receiving and shipping
Software for GIS MT integration
Connecting to an EDM operator
Staff training
Industry participants estimate that the overall implementation costs for a mid-sized medical device distributor range from 500,000 to 2,000,000 rubles.
Unmarked Remaining Stock
Decree No. 894 includes transitional provisions for goods introduced into turnover before mandatory marking took effect:
| Product Type | Permitted Actions Without Marking |
|---|---|
| Products with an expiration date (diapers, pads) | May be sold until expiry, provided they entered turnover before March 1, 2024 |
| Products with a designated service life (hearing aids, CT scanners) | The marking or sale deadline expired on August 31, 2024. Sale is currently prohibited |
| Products acquired by healthcare organizations for their own needs before marking was introduced | May be stored, transported, and transferred free of charge without marking. Sale requires marking first |
The transition period for second-wave products has concluded. Unmarked devices with a designated service life remaining in circulation constitute a violation of the law.
How to Register in the System
Registering as a turnover participant takes from a few days to three weeks, including the testing phase.
The procedure:
Obtain a UKEP. An Enhanced Qualified Electronic Signature is issued by accredited certification centers. Since 2022, heads of legal entities obtain their UKEP from the Federal Tax Service (FTS) of Russia; employees may use personal electronic signatures accompanied by a power of attorney.
Register at честныйзнак.рф. Log in using your UKEP, complete the application, and provide your taxpayer identification number (INN), organization name, and contact details. Select the product group «Medical Devices.»
Complete information interaction testing. Within 15 calendar days of registration, ensure your software is ready to exchange data with GIS MT. Submit a testing application and complete testing within the following 15 days.
Gain access to an emission registration device. Manufacturers and importers need this to order and receive marking codes. Access is provided free of charge.
Conclude an agreement with an EDM operator. Select an operator connected via roaming to the Chestny ZNAK system.
Registration deadline: no later than 7 calendar days from the start of activities involving marked goods. For organizations in remote areas, this period is extended to 30 days.
Product Descriptions in the Catalog
Before ordering codes, a product must be registered in the National Catalog of Marked Goods.
For hearing aids, CT scanners, and air disinfection units, provide: the applicant’s INN, product code (GTIN) if available, full product name, trademark, 10-digit HS Code, country of manufacture, product type, manufacturer’s model number, model name and number from the RC, declaration of conformity number and date if available, and the expiration date or service life.
For coronary stents, additionally specify: stent length, free outer diameter, construction type, and frame material.
For sanitary and hygienic incontinence products, additionally specify: product category and type, number of units per pack, absorbency capacity, composition, waist circumference (for diapers), size (for underpads), and target gender (for pads).
If the information does not match the State Register of Medical Devices, registration will be denied.
Introduction into Turnover
For a Russian manufacturer:
Order marking codes in the Chestny ZNAK personal account
Pay for the codes (50 kopecks per unit, excluding VAT)
Receive the codes and convert them into Data Matrix barcodes
Apply the codes to the packaging or label
Submit a code application report to GIS MT
Submit an introduction-into-turnover notification upon the first transfer of goods to a buyer
For an importer:
Register the product in the catalog
Order and pay for the codes
Apply the codes to the packaging (either at the overseas factory or in Russia after import)
Specify marking codes or an Aggregated Customs Code (ACC) during customs declaration
Submit an introduction-into-turnover notification after customs release
Customs Clearance of Marked Devices
A significant share of hearing aids, coronary stents, and CT scanners is manufactured abroad. For importers, marking requirements add steps to standard customs clearance.
When filing a customs declaration (CD), marking information is entered in box 31.
Importers may choose one of three options:
Listing individual Identification Codes (ICs) item by item. Suitable for small batches.
Identification Codes of Transport Packaging (ICTPs). Used when goods are aggregated into boxes or pallets.
An Aggregated Customs Code (ACC) generated within the Chestny ZNAK system. It compresses information on thousands of codes into a single string, simplifying the CD.
The Federal Customs Service (FCS) system automatically queries GIS MT to verify code legitimacy. Unregistered codes or codes belonging to another party will cause the release of goods to be suspended.
For goods arriving without marking, the customs warehouse procedure (IM70) is available. Importers apply Data Matrix codes directly at the warehouse under customs supervision.
| Category | Warehouse Marking Requirements |
|---|---|
| Coronary stents | Temperature regime and sterility must be maintained |
| CT scanners | Lifting equipment required for large-scale machinery |
| Hearing aids | Standard conditions; code applied to consumer packaging |
CT scanners are delivered disassembled as a set of modules. The importer marks the main unit that determines the identification of the entire system per the RC. Components supplied as spare parts are not subject to mandatory marking unless they fall under separate HS codes in Decree No. 894.
Transfer of Goods and Withdrawal from Turnover
Since September 1, 2025, every transfer of hearing aids, stents, and CT scanners between turnover participants is processed via EDM.
The seller generates a UTD listing all marking codes, signs it with a UKEP, and sends it to the buyer and GIS MT via the EDM operator.
The buyer receives the UTD through EDM, reconciles the codes in the document against the goods physically received, and signs the document with a UKEP. Data is automatically routed to GIS MT.
If the buyer discovers discrepancies (wrong goods or damaged codes), they can reject the document or request a correction via a Universal Correction Document (UCD). For retail sales, the code is scanned at the checkout and data is dispatched automatically via the fiscal data operator.
Withdrawal from turnover means tracking for the product ends within the system.
Typical grounds include:
Retail sale to an individual at a cash register
Use in providing medical care to a patient (notification to GIS MT required within 3 working days)
Write-off, disposal, or destruction
Export
If a device was withdrawn for medical use but went unused, it can be returned to turnover by submitting a return-to-turnover notification.
Liability for Violations
| Violation | Subject | Penalty |
|---|---|---|
| Production or introduction into turnover without marking (Art. 15.12 of the Code of Administrative Offences) | Officials | 5,000 – 10,000 ₽ + confiscation |
| Legal entities | 50,000 – 100,000 ₽ + confiscation | |
| Sale without marking (Art. 15.12 of the Code of Administrative Offences) | Citizens | 2,000 – 4,000 ₽ + confiscation |
| Officials | 5,000 – 10,000 ₽ + confiscation | |
| Legal entities | 50,000 – 300,000 ₽ + confiscation | |
| Failure to submit data to GIS MT (Art. 15.12.1 of the Code of Administrative Offences) | Officials | Warning or 1,000 – 10,000 ₽ |
| Legal entities | 50,000 – 100,000 ₽ |
Article 171.1 of the Criminal Code provides for up to 6 years of imprisonment for the production, acquisition, storage, transportation, or sale of unmarked goods on a large scale (exceeding 1.5 million rubles).
What to Do
Verify your registration in Chestny ZNAK. Log into your personal account at честныйзнак.рф. Ensure the «Medical Devices» product group is active. If not yet registered, do so without delay: fines accrue from the first day of handling marked goods.
Conduct an inventory of remaining stock. Divide goods into three groups: marked (no action needed), unmarked with an expiration date (may be sold until expiry, if entered turnover before March 1, 2024), and unmarked with a designated service life (cannot be sold — requires immediate marking or write-off).
Set up electronic document management. Conclude an agreement with an EDM operator connected via roaming to the Chestny ZNAK system. Test UTD exchanges with several counterparties before the first real shipment arrives.
Train your personnel. Warehouse staff must scan codes upon receipt. Accountants must confirm UTDs in the EDM system. Pharmacy staff must handle marked goods at the cash register. Everyone needs to understand their specific role.
Verify counterparties before each shipment. Confirm that your supplier is registered in the system and can ship marked goods with a valid UTD. Request a sample document in advance.
Status of the Pilot Project for New Categories
Government Decree No. 620 dated May 17, 2024, launched a voluntary pilot project for marking additional categories of medical devices. Codes were provided free of charge, and applying them did not require changes to the registration dossier.
The pilot was originally scheduled to conclude on February 28, 2026, after which a decision on mandatory marking would be made. However, in July 2025, intermediate results were reviewed at the Public Chamber of the Russian Federation, revealing a technical challenge: existing packaging materials and equipment did not consistently ensure stable Data Matrix code readability over a five-year lifespan. This became the primary argument for an extension.
Government Decree No. 204 dated February 28, 2026, extended the pilot until February 28, 2027, and structured it into three phases:
| Phase | Timeline | Product Categories |
|---|---|---|
| First | Until August 31, 2026 | Syringes, infusion systems, medical wipes, test tubes, masks, respiratory therapy devices, neonatal incubators, fillers and cosmetic threads |
| Second | March 2 – August 31, 2026 | Glucometers, test strips, blood pressure monitors, rapid tests |
| Third | April 2, 2026 – February 28, 2027 | In vitro reagent kits |
Participation remains voluntary. Codes are provided free of charge for all three phases. For manufacturers and importers of syringes, glucometers, masks, and the other listed products, joining the pilot is an opportunity to build compliant workflows before marking becomes mandatory. Following the conclusion of 2027, the Government will set deadlines for mandatory implementation.
The medical device marking system is now in full operation. Hearing aids, coronary stents, and CT scanners are tracked item by item. Sanitary-hygienic products and medical gloves moved to item-by-item accounting on March 1, 2026. A voluntary pilot is running in parallel for the next wave: syringes, glucometers, masks, and reagent kits. Companies that join now avoid a difficult transition later.
Regulatory Framework:
1. Criminal Code of the Russian Federation, Article 171.1
2. Government Decree No. 894 dated May 31, 2023, «On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means» (as amended September 12, 2025)
3. Government Decree No. 1409 dated September 12, 2025, «On Amending Government Decree No. 894 dated May 31, 2023» (deferral of EDM deadlines for sanitary-hygienic products and medical gloves)
4. Government Decree No. 577 dated May 8, 2019, «On Approval of the Fee for Providing Marking Code Services»
5. Government Decree No. 1955 dated December 31, 2019, «On Ensuring Access to Information in GIS MT» (as amended November 1, 2025)
6. Government Decree No. 620 dated May 17, 2024, «On Conducting a Pilot Project for Marking Certain Types of Medical Devices» (as amended February 28, 2026)
7. Government Decree No. 204 dated February 28, 2026, «On Amending Government Decree No. 620 dated May 17, 2024» (extension of pilot to February 28, 2027; three phases; new categories)
8. Federal Law No. 381-FZ dated December 28, 2009, «On the Fundamentals of State Regulation of Commercial Activities in the Russian Federation»
10. Government Directive No. 792-r dated April 28, 2018, «On Approval of the List of Goods Subject to Mandatory Marking with Identification Means»
11. Code of Administrative Offences of the Russian Federation, Articles 15.12, 15.12.1