Armenia Used and Refurbished Medical Device Imports: The 5-Year Rule

1. Key takeaways

Armenia applies a structure of general prohibition with a refurbished exception to used medical devices: under Decision No. 429-Ն, the import of used medical devices is not allowed; however, refurbished devices may be imported when 2 conditions are met simultaneously — no more than 5 years may elapse between the date of manufacture and the time of import, and the import must be processed on the basis of documents issued by the manufacturer or its authorized technical service organization. The GRZAN conclusion: the compliance cost of bringing refurbished devices into Armenia is far higher than for new devices, so this route is not recommended as a regular business model and is suitable only for case-by-case disposal of high-value equipment. Companies planning volumes of refurbished units should re-examine whether new device supply or local service partnerships achieve the same commercial goal at lower regulatory risk.

2. Legal basis

3. Expert insights

Insight 1: The prohibition targets used status; the exception targets refurbishment. Decision No. 429-Ն provides that the import of used medical devices is not allowed, with the exception of refurbished devices. GRZAN note: the legislative logic is that used status means an uncontrollable condition, whereas refurbishment means the condition has been re-confirmed. The key to importability is therefore not the age or appearance of the equipment but whether a verifiable refurbishment process has been completed.

Insight 2: The 5-year period runs from the date of manufacture. The exception provides that the period from the date of manufacture of the device to the time of import must not exceed 5 years. GRZAN note: the starting point is neither the date of first use nor the date of completion of refurbishment, but the date of manufacture; for long-life products such as large imaging equipment, 5 years is a tight threshold.

Insight 3: Refurbishment documents must be issued by the manufacturer or its authorized technical service organization. The exception provides that the import must be processed on the basis of documents issued by the manufacturer of the medical device or its authorized technical service organization, and these documents must contain: first, a description of the refurbishment work performed; second, a conclusion confirming that after refurbishment the device meets safety, quality and performance requirements (a certificate, declaration, final test report or equivalent document). GRZAN note: reports issued by third-party repair companies do not satisfy the requirement unless the repair company has been formally authorized by the manufacturer as its technical service organization and can evidence that authorization.

Insight 4: Used status must be actively declared at filing. Government Decision No. 1619-Ն of 2024-10-17 added point 10.2 to Annex 1: when importing used medical products, the importer, in the application submitted through the Single Window electronic system, must also state the fact that the products are used in the commercial description of the product field. GRZAN note: this is a mandatory disclosure duty; concealment constitutes a false declaration, the consequences of which are far heavier than an honest declaration that is later refused.

Insight 5: Refurbished devices still go through the full import chain. Refurbished devices likewise require SCDMTE identification and an import (conformity) certificate issued by the Ministry of Health, and the certificate remains a one-time permit, valid for 1 year and void once customs clearance is completed. GRZAN note: the refurbished exception simplifies no procedural step; it merely adds two substantive conditions, the 5-year limit and the refurbishment documents, on top of the standard route.

4. Practical recommendations

1. Assess case by case, not in volume plans: evaluate refurbished devices unit by unit for feasibility and do not treat them as a regular product line.
2. Calculate the 5-year period first: count from the date of manufacture device by device; abandon units that exceed the limit before spending on identification.
3. Lock the issuing entity: confirm that the refurbishment documents are issued by the manufacturer or its authorized technical service organization, and obtain evidence of the authorization relationship as well.
4. Documents must contain both elements: the description of the refurbishment work plus the conclusion on compliance with safety, quality and performance requirements after refurbishment; neither may be missing.
5. Declare truthfully: state the fact of prior use in the commercial description of the product field and upload the 5-year calculation together with the refurbishment documents.

5. Verification checklist

1. □ The prohibition-and-exception structure for used devices under Decision No. 429-Ն has been confirmed.
2. □ The period from date of manufacture to date of import has been calculated unit by unit against the 5-year limit.
3. □ The description of the refurbishment work issued by the manufacturer or its authorized technical service organization has been obtained.
4. □ The conclusion documents confirming compliance with safety, quality and performance requirements after refurbishment have been obtained.
5. □ Evidence of the authorization relationship of the refurbishment document issuer has been verified.
6. □ The fact of prior use has been stated in the commercial description of the product field of the Single Window.
7. □ It has been confirmed that refurbished devices still go through the full import (conformity) certificate procedure (one-time, 1 year, void after clearance).

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 refurbishment compliance reviews. For tailored advice on license-holder, import and fee matters, contact info@grzanglobal.com.