Armenia Single-Window Electronic Application and Annex 2 Documentation

1. Key takeaways

Filing for the import (conformity) certificate is fully electronic: an electronic application is submitted through the Single Window for Foreign Trade of the Republic of Armenia electronic system, with PDF color scans of the documents specified in Annex 2 of Decision No. 429-Ն attached. The GRZAN conclusion: the three most frequent causes of filing failure are attachments that are not color scans, batch numbers that are not stated, and non-standard completion of the application by trade name. Among these, filing by trade name is a mandatory requirement newly added by the 2024 amendment, so legacy filing templates built before 2024 must be revised. Companies that treat the electronic filing as a formality typically discover the gaps only after the application is returned, losing weeks of shipping time.

2. Legal basis

3. Expert insights

Insight 1: The four categories of import documents for unregistered devices are the core of Annex 2. To carry out the identification required for importing an unregistered medical device, the following must be submitted: a) documents proving that the device has been approved for use (national registration) in the country of origin or in an IMDRF member jurisdiction, or a substantiated reference to such documents, including a declaration of conformity citing the relevant register; b) quality conformity certificates for each batch of the imported medical device (such as final inspection reports, batch release certificates, batch release attestations, certificates of analysis or other equivalent documents issued by the manufacturer or its authorized representative, stating the batch or lot number); c) the instructions for use or a link to their electronic version; d) clear color images or drawings showing the labeling. GRZAN note: the requirement in item b that the batch or lot number be stated is a hard rule; generic quality certificates without batch numbers are returned.

Insight 2: The 2024 amendment added three operating rules. Government Decision No. 1619-Ն of 2024-10-17 amended Annex 1 of Decision No. 429-Ն: after the first sentence of point 9 it added a sentence requiring the applicant to state the medical products being imported by trade names in the application; it added new point 10.1, providing that when importing medical devices of risk class 1 (excluding sterile devices and those intended for in vitro diagnostics), a quality conformity certificate for each batch or other documents proving the quality of that batch may be submitted in lieu of a declaration of conformity; and it added new point 10.2, providing that when importing used medical products, the importer must state the fact that they are used in the commercial description of the product field of the Single Window electronic system. GRZAN note: point 10.2 echoes the used-device rule of Decision No. 429-Ն — declare truthfully at filing, otherwise the declaration is false.

Insight 3: The effective dates are split. Decision No. 1619-Ն entered into force on 2024-10-18, but its newly added point 4.1 enters into force on 2025-01-19. GRZAN note: this is a phased entry into force within a single amendment instrument; when verifying which version applies, the effective date must be confirmed point by point rather than applied wholesale from the date of the whole document.

Insight 4: Point 10.1 is a substantive relief for low-risk products. For class 1 risk products (non-sterile, non-IVD), a batch-by-batch quality certificate may replace the declaration of conformity. GRZAN note: what is saved is the separate preparation of a declaration of conformity, but the batch quality certificate must still be submitted — relief does not mean exemption, and it would be a misreading to conclude that class 1 products require no documents.

Insight 5: The operating sequence for electronic filing (GRZAN method).

1. Confirm registration status: registered, prepare the copy of the registration certificate; unregistered, prepare the four document categories a to d.
2. Organize the filing list by trade name: per the added requirement of Annex 1, point 9, complete each item by trade name.
3. Prepare PDF color scans: scan all attachments as color PDFs at a resolution at which labels and text remain legible.
4. Check batch numbers: verify that batch or lot numbers on the batch quality certificates match the physical goods.
5. Declare used status truthfully: state it in the commercial description of the product field as required by point 10.2.
6. Submit and track: file through the Single Window and track the SCDMTE expert opinion and the issuance result of the Ministry of Health.

4. Practical recommendations

1. Build trade name master data: make trade name a standalone field, distinct from the generic name and model, to keep filing entries consistent.
2. Standardize color scans: prescribe scanning parameters (color, PDF, minimum resolution) and eliminate black-and-white scans and photographs.
3. Triple-check batch numbers: before shipment, verify that the physical label, the quality certificate and the application form all show the same batch number.
4. Use the relief for class 1 products: for eligible class 1 non-sterile non-IVD products, replace the declaration of conformity with batch quality certificates under point 10.1.
5. Declare used status truthfully: for refurbished devices, state the fact of prior use in the commercial description of the product field and have the 5-year calculation and refurbishment documents ready.

5. Verification checklist

1. □ It has been confirmed that the filing gateway is the Single Window for Foreign Trade of the Republic of Armenia electronic system.
2. □ The filing list has been completed by trade name as required by the added sentence of Annex 1, point 9.
3. □ PDF color scans of the documents specified in Annex 2 have been prepared.
4. □ It has been checked that the batch quality certificates state batch or lot numbers matching the physical goods.
5. □ It has been confirmed whether the product qualifies for the class 1 relief of point 10.1.
6. □ For used or refurbished devices, the fact of prior use has been stated in the commercial description of the product field.
7. □ The phased effective dates of Decision No. 1619-Ն (2024-10-18 and 2025-01-19) have been checked.

Regulatory information verified as of October 30, 2026.

This guide was prepared and translated by GRZAN. GRZAN provides end-to-end regulatory services for medical device manufacturers entering Armenia and the Eurasian Economic Union, including registration, import conformity certificates, authorized representative services and filing support. For tailored advice on license-holder, import and fee matters, contact info@grzanglobal.com.