Armenia EAEU Nomenclature NMI: Catalogue Coding Rules and GMDN Harmonisation

1. Key takeaways

The Eurasian Economic Union nomenclature of medical devices (NMI) is approved by Executive Board Decision No. 46 dated 2018-04-03, and its maintenance rules are laid down by Executive Board Decision No. 177 dated 2015-12-29; the nomenclature is harmonised with the Global Medical Device Nomenclature (GMDN). The GRZAN conclusion is that the use of catalogue codes in the union common procedures is mandatory, and a coding mismatch will cause the registration dossier to be returned at the intake stage. The matching method should start from GMDN terms and work backwards, not from the colloquial product name forwards.

2. Legal basis

3. Expert insights

Insight one: the statutory attributes of the catalogue are written in the catalogue passport. Under the passport approved by Executive Board Decision No. 46 dated 2018-04-03, the elements of the catalogue include: the code identifier 0__; the type 2 (classifier); the name Nomenclature of Medical Devices of the Eurasian Economic Union; the abbreviation NMI; the designation EC 0_-201 (first edition); the adopting act being the decision itself; the operator being the Federal Service for Surveillance in Healthcare of the Russian Federation; the purpose of systematising information on types of medical devices, including with regard to their classification characteristics; and the scope of use in forming registration dossiers, controlling the circulation of medical devices and ensuring information exchange, including in the implementation of common procedures. The catalogue is harmonised with the GMDN and with ISO 15225:2010 on nomenclature data structures, using the method of establishing correspondences with trusted sources. The GRZAN observation is that this passport is the authoritative basis for the positioning of the catalogue: it is a classifier, and it is internationally harmonised.

Insight two: the use of catalogue codes is mandatory. Article 4 of Executive Board Decision No. 46 dated 2018-04-03 provides that the catalogue applies from the date of entry into force of the decision and that catalogue codes must be used when implementing the common processes in the sphere of medical device circulation within the union. The GRZAN observation is that this mandatory wording means the code is verified at the registration dossier stage, at import declaration and in circulation control alike.

Insight three: the maintenance rules establish a GMDN synchronisation mechanism. Article 4 of Decision No. 177 requires that the names and descriptions of every type of medical device in the union catalogue correspond to the names and descriptions of the types contained in the Global Medical Device Nomenclature. Article 5 provides that the systematisation of catalogue types uses the categories of the GMDN. Article 8 sets out the functions of the catalogue operator, which include translating the GMDN type names and descriptions into Russian, assigning unique codes and entering them into the catalogue; processing new types and changes received from the GMDN agency and making the corresponding modifications; excluding types from the catalogue on the basis of exclusion information from the GMDN agency; and transmitting catalogue changes to the Eurasian Economic Commission through the union integrated information system for uploading to the union information portal. The GRZAN observation is that the catalogue is updated periodically, so code matching must be re-verified immediately before submission; results from an earlier project cannot be reused.

Insight four: the catalogue is free and public, and member states must contract with the GMDN agency. Decision No. 177 provides that the catalogue is formed and maintained electronically by the operator and placed on the union information portal by the Eurasian Economic Commission, where it is publicly available and provided to users free of charge and on a non-discriminatory basis. At the same time, the authorised bodies of the member states must conclude agreements with the GMDN agency to use the original codes of the medical device types it contains and to have new types included in the GMDN. The GRZAN observation is that if a product is a novel device with no corresponding GMDN type, the procedure for inclusion in the GMDN must be completed first, which significantly lengthens the timeline and should be identified at the project initiation stage.

Insight five: the matching method (the GRZAN working method).

1. Start from the intended purpose to determine the GMDN term, not from the colloquial product name.
2. Navigate by category: use the GMDN category system to converge level by level.
3. Check the Russian name and description: work against the Russian entries in the catalogue and confirm they match the technical description of the product.
4. Capture the unique code: record the catalogue code and version number and enter them in the registration dossier and the application form.
5. Re-verify before submission: because the catalogue follows GMDN updates, confirm before each submission that the code has not changed or been excluded.

4. Practical recommendations

1. Front-load coding to project initiation: make the NMI code a master data field of the product, fixed together with the technical documentation.
2. Identify novel devices early: where the GMDN has no corresponding type, assess the time cost of the inclusion procedure at the outset.
3. Always re-verify before submission: the catalogue is updated, so the validity of the code must be reconfirmed before every submission.
4. Check the Russian descriptions: reconcile the product technical description against the Russian catalogue entries to prevent mismatches of name or description.
5. One code per intended use: products with different intended purposes must not share a single code, even when they look identical.

5. Verification checklist

1. □ The NMI code has been determined by working backwards from the GMDN term.
2. □ The catalogue code and version number are recorded in the registration dossier and the application form.
3. □ The Russian name and description in the catalogue match the product technical description.
4. □ It has been confirmed that the product is not a novel device requiring GMDN inclusion first, or that procedure has been started.
5. □ The catalogue code has been re-verified for changes or exclusions immediately before submission.
6. □ No two products with different intended purposes share the same code.
7. □ The mandatory use of the catalogue code in union common procedures has been confirmed under Article 4 of Decision No. 46.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives with NMI coding for the Armenian market, from GMDN-based term matching and novel-device identification to code governance across the dossier and submission re-verification. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.