Digital Marking — Chestny ZNAK (Honest Sign)
Government Decree No. 894 · Roszdravnadzor · CRPT (Centre for Research in Perspective Technologies)
What Is Chestny ZNAK?
Chestny ZNAK (Честный ЗНАК — "Honest Sign") is Russia's national mandatory digital product marking and traceability system. Administered by the Centre for Research in Perspective Technologies (CRPT) under government authority, it assigns a unique Data Matrix code to each individual unit of a product, enabling track-and-trace from manufacture to the end consumer.
The system covers an expanding range of product categories, including specified medical device types. From September 2023, Russia began the phased mandatory rollout of Chestny ZNAK for medical devices under Government Decree No. 894.
Chestny ZNAK is a Russia-specific traceability system unrelated to EAEU UDI frameworks. Compliance is mandatory for covered device categories regardless of which registration route (national or EAEU) was used.
Scope — Which Devices Are Covered?
Mandatory marking applies to medical devices in specific product categories. The current scope includes (subject to Government updates):
| Category | Examples |
|---|---|
| Rehabilitation aids | Canes, crutches, walkers, wheelchairs |
| Orthopedic products | Orthopedic footwear, custom insoles |
| Hearing aids | All hearing aid types |
| Coronary stents | Drug-eluting and bare metal stents |
| Hygiene products | Adult incontinence products, urological pads |
| Medical gloves | Latex, nitrile, and vinyl gloves |
| CT scanners | Computed tomography equipment |
| Air disinfection devices | Ultraviolet and other disinfection units |
Scope may expand over time. Verify current applicability via the official Chestny ZNAK portal: честныйзнак.рф.
What Is a Data Matrix Code?
Each unit must carry a unique Data Matrix 2D barcode that encodes:
- GTIN (Global Trade Item Number) identifying the product
- Individual serial number unique to that unit
- Cryptographic verification code (generated by CRPT)
The Data Matrix code enables scanning at each supply chain step — manufacturer/importer → distributor → pharmacy/medical facility — with each movement recorded in the national database.
Who Must Comply?
All participants in the supply chain for covered device categories:
| Participant | Obligation |
|---|---|
| Manufacturer / Importer | Apply Data Matrix codes to units before supply; register in Chestny ZNAK system |
| Distributor / Wholesaler | Scan codes at acceptance and dispatch; transmit movement data |
| Pharmacy / Retailer | Scan codes at sale or dispensing; transmit transaction data |
| Healthcare facility | Scan codes on receipt and consumption of marked devices |
For foreign manufacturers, the Russian Authorized Representative (RUS REP) typically coordinates Chestny ZNAK registration and first-import marking obligations. See Authorized Representative.
Registration and Setup
To participate in Chestny ZNAK, manufacturers and importers must:
- Register on the Chestny ZNAK portal at честныйзнак.рф using a qualified electronic signature (QES)
- Obtain GTINs for all covered products (via GS1 Russia or equivalent issuing agency)
- Order Data Matrix codes from CRPT for each product/batch
- Apply codes to device units or packaging before supply into Russia
- Transmit movement data at each supply chain handover
Foreign manufacturers importing into Russia must either apply codes at the factory (pre-import marking) or apply codes in Russia at a bonded warehouse before customs clearance.
Compliance Consequences
Non-compliance can result in:
- Sales blockage at point of sale — unmarked devices cannot be legally sold
- Enforcement action by Roszdravnadzor — seizure, fines, import suspension
- Customs rejection — import shipments without valid marking may be refused clearance
Encoding errors or delayed data transmission can also trigger sales blockage even if the physical Data Matrix code is correctly printed. Ensure real-time data transmission systems are operational.
Relationship to Registration Certificate
Chestny ZNAK marking applies to devices that hold a valid State Registration Certificate. The GTIN and registration certificate number must be linked in the CRPT system. A change in registration certificate (e.g., following a significant variation) may require CRPT database updates.
Practical Steps for Foreign Manufacturers
- Confirm whether your device categories fall within the current scope
- Register a legal entity or RUS REP in the Chestny ZNAK system with a QES
- Obtain GS1 GTINs for all covered SKUs
- Establish a data transmission workflow for each supply chain step
- Decide on pre-import marking (at factory) or in-Russia marking (at bonded warehouse)
- Test the end-to-end scanning and data transmission workflow before first commercial shipment
Work with your RUS REP early — they often have established workflows for Chestny ZNAK compliance and can coordinate CRPT registration on your behalf.
Further Resources
- Official portal: честныйзнак.рф (Russian)
- Government Decree No. 894 (marking rules for medical devices)
- CRPT technical documentation for data transmission formats