Armenia
Armenia is an emerging market with an expanding healthcare system and increasing demand for imported medical devices. This context offers significant opportunities for companies looking to enter the Armenian market.
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Regulatory Framework
The competent authority for medical device regulation in Armenia is the Ministry of Health of Armenia (MOH). The country follows the regulations of the Eurasian Economic Union (EAEU).
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation must be in Armenian and/or Russian. |
| Local Representative | Required for foreign manufacturers. |
| Certification | EAEU certification will be mandatory once enforced. |
| Local Registration | Medical devices do not currently require registration for import and sale in Armenia. This provision is valid until December 31, 2025. After this date, the requirement for registration of equipment and medical products may be introduced. |
Challenges and Operational Advice
- Evolving Regulations: It is necessary to monitor any regulatory updates.
- Variable Timelines: The EAEU procedure can take over 24 months. The timeline for local procedures can vary significantly depending on the device type.
FAQ
- License Duration? The EAEU certificate has no expiration date.