Armenia Medical Device Registration Dossier: EAEU Decision No. 46 Annex 4 Structure

1. Key takeaways

The document list of the registration dossier is laid down by Annex 4 of Decision No. 46, and it is tiered by risk class — the higher the class, the thicker the list and the heavier the evidence requirements. The GRZAN conclusion is as follows: in practice, the Armenian competent authority accepts only 3 categories of mandatory submission items — the application form in the format prescribed by Decision No. 46, the document package in the format prescribed by Decision No. 46, and the proof of payment of the state fee. The substantive content of the document package, however, is determined entirely by Annex 4, so applicants must unpack that annex themselves; the authority does not provide an item-by-item completeness check at intake.

The recommended sequencing is fix the risk class first, then fix the document list, and only then fix the evidence. Operating in the reverse order — collecting studies and reports first and working out which class applies later — almost always produces rework, because the type of evidence required changes with the class. For example, a manufacturing site inspection report only enters the picture at sterile class 2a and above, so a dossier assembled before the class is confirmed may contain the wrong kinds of documentation altogether.

2. Legal basis

3. Expert insights

Insight one: Annex 4 is a tiered list, not a uniform list. The list of documents required for registration is set by Annex 4 of Decision No. 46 and depends on the risk class of the medical device. The GRZAN observation is that this means different-class products of the same company cannot share a single list even when they are built on the same technical platform. Low-risk documentation cannot simply be thickened and reused for a high-risk product, because the types of evidence differ: a manufacturing site inspection report, for instance, appears only at sterile class 2a and above, while performance data requirements scale up in both depth and breadth as the class rises.

Insight two: the intake threshold in Armenia is 3 categories of items. The official webpage of the Ministry of Health of Armenia lists exactly 3 items: first, the application form in the format prescribed by Board Decision No. 46 of the Eurasian Economic Commission dated 2016-02-12; second, the document package in the format prescribed by the same decision; third, the proof of payment of the state fee. The practical estimate used by GRZAN is that this terse formulation compresses the entire Annex 4 inventory into a single item called the document package. The applicant must therefore decompose Annex 4 internally; the competent authority will not perform a line-by-line verification service at submission.

Insight three: the translation requirement for foreign-language materials is written into the body of the rules. Decision No. 46 provides that registration dossier documents submitted in a foreign language must be accompanied by a Russian translation, certified in accordance with the procedure established by the legislation of the reference state. The GRZAN observation is that the certification procedure follows the reference state: if Armenia is chosen as the reference state, certification follows Armenian legislation; if another member state is the reference state, that state’s procedure applies. This is a genuine operational variable when selecting the reference state, and it should be resolved before any translation work begins.

Insight four: the applicant and the cost burden are locked down in the rules. The amended version defines the applicant as the manufacturer of the medical device or its authorised representative. The rules further state that the costs of registration and examination, coordination of expert opinions, changes (including the notification procedure) and reissuance of the registration certificate are borne by the applicant under the legislation of the member states. On the Armenian side, the state fees related to registration are determined under the State Fee Law of the Republic of Armenia, which sets out the payable amounts and payment mechanics in detail.

Insight five: the recommended preparation sequence (the GRZAN working method).

1. Fix the class: issue the classification rationale under Decision No. 173 (as amended in 2023 and 2025).
2. Fix the catalogue entry: allocate the NMI code under Executive Board Decision No. 46 dated 2018-04-03.
3. Fix the list: generate the document list for the applicable class from Annex 4, annotating each item with its source and responsible owner.
4. Fix the evidence: determine evidence types and test plans under Decision No. 28 (technical tests), Decision No. 38 (biological effects) and Decision No. 29 (clinical).
5. Fix the inspection: determine whether a manufacturing site inspection is mandatory under Decision No. 106 (as amended by Decision No. 43 of 2026).
6. Fix the texts: complete labelling and instructions for use under Decision No. 27, with Russian and, where needed, Armenian localisation.
7. Fix the translations: certify the Russian translations of foreign-language materials under the reference-state procedure.

4. Practical recommendations

1. List first, evidence later: generate the complete Annex 4 list for the applicable class and mark the status of each item before commissioning any study, so nothing is missed mid-course.
2. Front-load the NMI code: catalogue coding is the most frequent source of inconsistency between the application form and the technical file, so it should be settled before the list is generated.
3. Certify translations under the reference-state route: confirm the reference state before starting translation certification, avoiding rejection for using the wrong procedure.
4. Archive the state fee receipt separately: the payment proof is a mandatory intake item; prepare it alongside the application form and retain both the bank receipt and the authority’s confirmation.
5. Run a list-status board: manage every list item through four states — available, in preparation, requiring external input, not applicable — and review the board at fixed milestones.

5. Verification checklist

1. □ The classification rationale has been issued under Decision No. 173 and the risk class is confirmed.
2. □ The registration dossier document list for the applicable class has been generated from Annex 4.
3. □ The NMI code has been allocated and is consistent between the application form and the technical file.
4. □ The application form in the format prescribed by Decision No. 46 is ready.
5. □ The proof of payment of the state fee is ready.
6. □ Russian translations of foreign-language materials are complete and certified under the reference-state procedure.
7. □ A list-status board has been set up and the first status review has been completed.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Armenian market, from risk-class determination and Annex 4 list generation to evidence planning and reviewer-ready submission packages. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.