Registration of medical devices in Armenia

In terms of money, the socially-economical performance of the Armenian healthcare system is one of the lowest. However, statistically speaking, if we re-calculate expenses per capita, Armenia has an average level of spendings among the CIS and EAEU countries. 

Unlike other countries, Armenia didn’t have a national registration system for medical devices. In 2015, the country entered the EAEU and nowadays has a transaction period. Starting from 2021 the government has been implementing changes in regulation concerning medical devices circulation and importation. In 2025 the EAEU regulations should be fully adopted in the country, but meanwhile medical devices can circulate in the market according to the national import legislation. Once the transition period is over and mutual recognition of medical devices among the EAEU countries comes true, previously imported MDs will be withdrawn from the market upon their expiry date. 

Before that, medical devices can be imported for commercial purposes after receiving approval from the Ministry of Health - the process is carried out online and takes about 10 days.