Armenia Licensing under Decision No. 867: Storage and Distribution Obligations

1. Key takeaways

Armenia applies a licensing regime to medical device manufacturing and maintenance activities, with the rules established by Government Decision No. 867 of 2002-06-29; licensing and registration are two parallel regulatory tracks. The GRZAN conclusion: a foreign manufacturer that sets up a local entity in Armenia for manufacturing or maintenance must obtain a license separately; where the business is limited to import and distribution, the key obligations concentrate on verification of storage and transport conditions and on the triple pre-sale verification. Confusing the two tracks is a costly error: some companies assume a registration certificate covers everything, while others over-invest in licenses that their activity profile does not actually trigger.

2. Legal basis

3. Expert insights

Insight 1: The licensing scope of Decision No. 867 spans drugs and medical devices. The rules established by the Decision cover drug manufacturing, pharmacy activities, provision of medical care and services by organizations or individual entrepreneurs, drug wholesale, medical device manufacturing and medical device maintenance, and prescribe the corresponding license forms. GRZAN note: the device-related licenses are manufacturing and maintenance; sale or distribution as such is not among the enumerated activities, but this does not mean distribution is obligation-free — the obligations at the distribution stage fall mainly on the transport and storage requirements of Decision No. 27 and on the three import-stage verifications.

Insight 2: Article 45 places licensing alongside registration and conformity assessment. Article 45 of the Law on Medical Care and Services provides that the powers of the authorized body in the field of medical device circulation include licensing of statutory business types, state registration and conformity assessment of imported medical devices. GRZAN note: when planning the entity structure, companies should assess separately whether an operating license is needed, whether state registration is needed and whether import conformity assessment is needed; the three can apply cumulatively to the same product and the same entity.

Insight 3: Storage and transport are regulated even though they require no license. Article 5 of Decision No. 27 requires that medical devices be designed, manufactured and packaged so that their performance and effectiveness are not impaired when transported and stored according to the instructions for use; the labeling must state any special storage and/or circulation conditions (where applicable). GRZAN note: in Armenian import practice, before starting sales the importer must verify the consistency of the accompanying document data with the actual device information, including compliance with the prescribed special storage and transport conditions (practical estimate). This makes execution records for cold chain, light protection and moisture control a focus of regulatory attention.

Insight 4: Importer eligibility is tied to the eligibility to apply for the import certificate. Decision No. 429-Ն provides that legal entities and individual entrepreneurs importing medical devices, or persons authorized by them may submit the import (conformity) certificate application. GRZAN note: this creates a de facto entity threshold — only a legal entity or individual entrepreneur actually engaged in the import, or its authorized person, can file. A foreign manufacturer without a local entity must rely on a local importer or its authorized person to complete the filing.

Insight 5: Maintenance activities are licensed on the same footing as manufacturing. Decision No. 867 places medical device maintenance and medical device manufacturing together within the licensing scope. GRZAN note: companies providing after-sales repair services, including repair centers set up in Armenia by manufacturers, need a separate assessment of licensing needs; this is a separate track from product registration, and holding a registration certificate does not exempt anyone from the maintenance license.

4. Practical recommendations

1. Determine the activity type first: classify the operations into manufacturing, maintenance, import and distribution, and sales, and map the applicable licenses and obligations for each.
2. Assess maintenance centers separately: for planned local repair or technical service operations, assess licensing needs under Decision No. 867.
3. Keep records of storage and transport conditions: establish execution and monitoring records for temperature, humidity, light protection and moisture control, as evidence for the pre-sale verification.
4. Confirm the importer eligibility: confirm the identity of the local legal entity or individual entrepreneur responsible for the import and issue the corresponding authorization documents.
5. File licenses and registration separately: manage the operating license and the registration certificate as separate files, and never substitute one for the other.

5. Verification checklist

1. □ The applicable licenses and obligations have been determined by activity type (manufacturing, maintenance, import and distribution, sales).
2. □ It has been confirmed that local manufacturing or maintenance activities require a license under Decision No. 867.
3. □ It has been confirmed that the filing entity for import is the legal entity or individual entrepreneur importing the devices, or a person authorized by it.
4. □ Execution and monitoring records for special storage and transport conditions have been established.
5. □ It has been verified under Article 5 of Decision No. 27 that packaging and transport methods do not impair performance and effectiveness.
6. □ The operating license and the registration certificate have been filed and managed separately.
7. □ The general rules of the Law of the Republic of Armenia on Licensing have been reviewed against the current text.

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, licensing assessments, authorized representative services and distribution compliance support. For tailored advice on license-holder, import and fee matters, contact info@grzanglobal.com.