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Policy Update｜Russia Delays Medical Device Traceability Pilot Program

Time：2026-09-09 11:13:06

On 31 August 2026, the Government of the Russian Federation issued Resolution No. 1113, adjusting the timeline for the national identification‑mark pilot project for medical devices. The pilot for glucose meters, originally scheduled to end on 31 August 2026, has been officially extended. All relevant pilots covering glucose meters, blood‑glucose test strips and rapid‑test reagents will now uniformly close on 28 February 2027. This regulatory update grants Chinese exporters extra time for system integration and process modification. Manufacturers targeting the Russian market shall pay close attention.

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https://pharmvestnik.ru/content/news/eksperiment-po-markirovke-glukometrov-i-reagentov-prodlili-do-2027-goda.html

一、Medical‑Device National‑Mark Pilot

This pilot refers to Russia’s Chestny Znak (Honest Mark) traceability trial for medical devices. It builds a full‑chain Russian traceability system.

In short：each unit/box of covered medical devices gets a unique Data‑Matrix electronic identification code. Products are traceable across the whole supply chain: importer‑distributor‑retail pharmacy‑end‑user.

Core objectives of the programme：

Fight counterfeit glucose meters, defective test strips and rapid‑test reagents, mitigating safety risks for patients with diabetes.
Monitor product circulation, curb grey‑market imports and sales of expired goods.
Manufacturers complete marking, system‑connection and data‑reporting tests during the pilot phase. After the pilot ends, the scheme is highly likely to become legally mandatory. Products without valid marking will be banned from sale in Russia.

Important note：This remains a trial phase, not yet fully mandatory. Mandatory enforcement is expected after pilot completion.

二、Revised Policy Timeline

Under the original Resolution No. 620 of 2024, the pilot was rolled out in multiple phases：

Phase 1: Launch on 01 March 2025
Phase 2 (glucose meters): Originally 02 March 2026 – 31 August 2026
Phase 3 (glucose‑test strips & rapid‑test reagents): Originally 01 March 2026 – 28 February 2027

Key revision under Resolution No. 1113：

Phase‑2 glucose‑meter pilot is extended to 28 February 2027, synchronised with test‑strip and rapid‑reagent pilots，Other medical‑device groups within this pilot scope are also extended to the same deadline.

Other medical‑device groups within this pilot scope are also extended to the same deadline.

Covered product scope‑ Blood‑glucose meters ‑ Blood‑glucose test strips ‑ Various rapid‑detection test reagents

三、Implications for Chinese Exporters

（一）Implications for Chinese Exporters

Glucose‑meter exporters are no longer forced to finish pilot‑related revamp urgently before August‑31. Until 28 Feb 2027, companies may apply for code resources, revise packaging, connect to Russia’s national monitoring system and test end‑to‑end data‑submission workflows.

（二）Extension does not equal exemption from pilot obligations

The delay is not a waiver. Companies still need to familiarise themselves with marking rules, test code generation, labelling and supply‑chain data‑reporting, and resolve hardware‑software and logistic‑process issues in preparation for future mandatory rules.

（三）Risk reminder: Tighter regulation upon pilot expiry

When the pilot terminates on 28 February 2027, Russia is expected to formalise mandatory identification‑mark requirements. Without compliant national marking, glucose meters, test strips and rapid‑test reagents cannot circulate or be sold in Russia, which will directly affect customs clearance and retail shelf access.

（四）Recommended actions for manufacturers

Confirm whether your products fall under this pilot‑product list ‑ Evaluate workload for packaging revision, marking implementation and system‑interface development within your supply chain ‑ Work closely with your local authorised representative in Russia to track further regulatory changes and avoid non‑compliance risks when new rules take effect.

四、Closing Remarks

Russia keeps updating its medical‑device compliance framework, and the Chestny Znak traceability scheme is moving toward formal mandatory implementation. While this pilot extension offers Chinese manufacturers a valuable buffer, it does not signal looser oversight.

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