Until recently, there was no legal basis for regulating the circulation of medical devices in Armenia. The sale and import of medical equipment and products for medical use, according to the local legislation of the Republic of Armenia, did not require state registration. However, accession to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union made it possible to start regulating the circulation of this category of goods and improve the quality of products circulated in the country.

Currently, the authorized bodies and organizations in the field of the EAEU medical devices market in Armenia are the Ministry of Health of the Republic of Armenia and the Scientific Center for Expertise of Medicines and Medical Technologies In 2016, a department for the registration of medical devices was created in the scientific center.

Armenia’s accession to the Agreement was another step towards the development of the medical device market in the country. In addition to establishing a registration system, the production of medical devices is also actively developing in Armenia. So, for example, a new plant was opened in Yerevan for the production of syringes with needles of different thicknesses, for various purposes, devices for sampling blood for analysis, as well as a number of other products. The manufacturer, SMD (Special Medical Devices), is going to provide products not only to the domestic market, but also to export medical products, for example, to the Russian Federation.

It is worth noting that Russia is the largest and main partner of Armenia in the export of medical devices, which accounts for 84.3% of exports. Other major partners are Poland, Iran, Georgia, Belarus, the Netherlands and Kazakhstan.

More than half of the export falls on the product group “Medical, surgical and dental instruments and equipment”, the next group is the product group “Orthopedic devices or for the treatment of fractures”. Armenia also exports orthopedic devices, medical furniture, electronic devices for physical or chemical analysis, wheelchairs, respiratory equipment, blood pressure monitors, dental devices, artificial teeth, electronic thermometers and pyrometers.

At the same time, the share of imported medical devices in Armenia is still high, as can be seen in Figure 1.

Thus, the market of medical devices in Armenia has great potential, both from a regulatory point of view, and from the point of view of production and export of products outside the country.

References:

1. Movsisyan Shushan TRADE IN MEDICAL EQUIPMENT: OPPORTUNITIES OF ARMENIA // Amberd. 2021. No. 5 (12). URL: https://cyberleninka.ru/article/n/torgovlya-meditsinskim-oborudovaniem-vozmozhnosti-armenii
2. http://www.pharm.am/index.php/ru/2015-06-03-16-27-43/3571-2017-11-28-13-33-46
3. https://ru.armeniasputnik.am/20210524/Rossiyskim-bolnitsam—i-ne-tolko-novoe-proizvodstvo-medizdeliy-otkrylos-v-Erevane-27662430.html