Chestny ZNAK: Mandatory Digital Marking and Track-and-Trace for Medical Devices
Russia's national mandatory labelling system, Chestny ZNAK (Honest Sign), applies to medical devices. All medical devices placed on the Russian market must carry a Data Matrix (2D barcode) code issued through the Chestny ZNAK system and operated by the Centre for Research in Perspective Technologies (CRPT). The system enables end-to-end track-and-trace from manufacturer to patient.
Key obligations include:
- Manufacturers and importers must register with Chestny ZNAK and obtain unique serialised Data Matrix codes for each unit or consumer pack.
- Distributors and healthcare institutions must scan and report product movements at each transfer point, including receipt, sale, and disposal.
- MDLP (Medical Device Labelling and Product circulation) is the specific sub-system for medical devices within the broader Chestny ZNAK infrastructure.
📅 Effective / published: Phased rollout; mandatory for most medical device categories.
Foreign manufacturers exporting medical devices to Russia must arrange Data Matrix code generation and label application before shipment, or work with a Russian importer who is a registered Chestny ZNAK participant. The Authorised Representative (AR/LOI holder) typically coordinates compliance. Non-compliance — including devices without a valid Data Matrix or unregistered in MDLP — results in seizure and prohibition of sale.
View official source (Chestny ZNAK) ↗