Armenia Medical Device Market Surveillance: State Control and Inspection Findings

1. Key takeaways

State oversight of the medical device circulation market in Armenia is exercised by the authorized body under the law; the domestic legal source is Article 45 of the Law on Medical Care and Services for the Population, and the import (compliance) certificate is qualified as a non-tariff regulatory and restrictive measure that loses validity immediately after customs clearance. The GRZAN conclusion: the frequent nonconformities found in market inspections concentrate on 3 points — reuse of the one-time certificate across shipments, missing or nonconforming circulation marking (EAC) on registered devices, and labeling and instructions for use that do not meet Decision No. 27. Each of these findings is visible to an inspector without any file access, which is why they dominate inspection statistics.

2. Legal basis

3. Expert insights

Insight 1: Article 45 lists the organization of expertise and professional inspection among the powers of the authorized body. The article provides that the powers of the authorized body in the field of medical device circulation include circulation regulation, licensing, state registration, conformity assessment of imported devices, the organization of expertise and professional inspection, and the collection and analysis of information on adverse events (incidents). GRZAN note: this matches the division of labor under Government Decision No. 1795-Ն of 2022-11-24 — the Ministry of Health is the authorized body, and the Scientific Center of Drug and Medical Technology Expertise (SCDMTE) performs the expertise and professional inspection.

Insight 2: The three pre-sale verifications form a statutory duty chain for importers. According to the summary of Armenian practice, after obtaining the import compliance certificate and before starting sales, the importer must complete three verifications: ① verify that the accompanying documentation data are consistent with the actual device information, including compliance with the prescribed special storage and transport conditions; ② for registered medical devices, verify the presence of the circulation marking approved under Council Decision No. 26 and verify that the product marking meets the requirements of Council Decision No. 27; ③ for unregistered medical devices, verify that the packaging or instructions for use carry the manufacturer’s name, trademark and contact information, and the details of the official representative in the Republic of Armenia (practical estimate: the above is an industry practice summary; the specific requirements should follow the competent authority’s position). GRZAN note: item ② places the verification responsibility for the EAC marking on the importer, so the foreign manufacturer must apply the marking correctly before release.

Insight 3: The one-time nature of the import certificate is a key inspection target. Decision No. 429-Ն and the Ministry of Health explanation state that the import (compliance) certificate is a one-time import permit for a single entry into Armenia, valid for 1 year, and loses validity after customs clearance. GRZAN note: reusing the same certificate across shipments (for example, one certificate covering several arrivals) is the most easily detected violation, because customs clearance records expose it directly.

Insight 4: Labels and instructions for use are visible inspection objects. Article 9 of Decision No. 27 requires information identifying the device, the manufacturer and the country of origin, and information for users on safety, functional properties and operating characteristics, for each device; Article 11 requires this information to be provided in Russian, and in the national language where member state legislation so requires. GRZAN note: an inspector can check the label without consulting any file; missing label elements (country of origin, batch number, year and month of expiry, sterilization method) are the most common nonconformities.

Insight 5: Decision No. 174 feeds information obtained through oversight into surveillance. Article 4(a) of Decision No. 174 provides that surveillance is based on the analysis of adverse event (incident) reports received when the authorized bodies of member states exercise state oversight (control) over device circulation. GRZAN note: inspection findings flow back into the surveillance system and become an input to suspension and cancellation procedures; on-site correction and system-level correction must therefore be carried out in parallel.

4. Practical recommendations

1. Apply for the certificate shipment by shipment: write the one-time, cleared-and-expired rule into the logistics SOP and eliminate reuse across shipments.
2. Verify the EAC before release: add an EAC marking verification step to the release process (the four elements of the design and its placement).
3. Identify the local representative for unregistered devices: state the official representative in the Republic of Armenia on the packaging or instructions for use.
4. Self-check labels against the 10-item list: with particular attention to country of origin, batch number, expiry (year and month) and sterilization method.
5. Keep storage and transport records: retain execution and monitoring records for temperature, humidity and other conditions for the pre-sale verification.

5. Verification checklist

1. □ Confirmed that the domestic legal source of oversight is Article 45 and the technical body is the SCDMTE.
2. □ Established an SOP for shipment-by-shipment application of the import (compliance) certificate, eliminating reuse across shipments.
3. □ Added an EAC marking verification step to the release process.
4. □ The packaging or instructions for use of unregistered devices state the official representative in the Republic of Armenia.
5. □ Label self-check completed against the 10-item list of Decision No. 27.
6. □ Execution and monitoring records for special storage and transport conditions retained.
7. □ Established a closed loop for routing inspection findings back into the surveillance and remediation system.

Regulatory information verified as of October 30, 2026.

About GRZAN: GRZAN supports medical device manufacturers entering Armenia and the Eurasian Economic Union with regulatory registration, quality management systems, post-market surveillance and import clearance compliance. For inquiries, contact info@grzanglobal.com.