On February 9, 2026, an important protocol was signed in Moscow , amending the rules governing the circulation of medical devices within the Eurasian Economic Union. The document significantly expands the list of situations in which registration of medical devices in the EAEU is not required. We explore what this means for the market, patients, and manufacturers.
The essence of the changes:
EAEU member states have supplemented paragraph 11 of Article 4 of the 2014 framework Agreement. The list of exceptions has now been expanded. Here are the key innovations that allow for the elimination of the unified registration requirement:
1. Saving Lives: Individualized Approach
: Medical devices imported into the customs territory of the Union for vital indications of a specific patient. The main requirement is permission from the authorized body of an EAEU member state. This is a huge step for patients who require urgent care and unique equipment or consumables.
2. Made in the EAEU for Export:
If the product is not planned for sale on the EAEU domestic market, the lengthy registration process is no longer necessary. Great news for exporting manufacturers!
3. Smart kits without bureaucracy.
These are sets of medical devices and medications (packages, kits, sets, first aid kits) in a common package, provided that the consumer packaging of each component is preserved, the contents of the kits are registered and completed in accordance with the laws of a specific state and are intended for circulation only within its territory.
Timeframe and mechanism of operation:
The Protocol will enter into force 10 days after signing, i.e., on February 19, 2026.
Final entry into force will follow the receipt of the final notification of completion of domestic procedures by all participating countries.
Russian context: As a reminder, the order signing this Protocol (No. 2920-r) was approved by the Russian Government back in October 2025. The process is proceeding according to plan.
- Important for those still considering:
Transitional periods for registration under the old national rules are in effect: Applications under the national rules can be submitted until December 31, 2027. Products already registered under the old rules can be re-registered or amended until December 31, 2028. - Conclusion: The EAEU continues to flexibly adjust regulations, removing barriers for emergency humanitarian cases, supporting exporters, and local kit manufacturers. The market is becoming more adaptive!
