Armenia

Ministry of Health

Ministry of Health

Regulatory Authority

Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan at the Ministry of Health of the Republic of Armenia

Member of Eurasian Economic Union (EAEU)

Medical Device Regulation

Decree No. 46 – On the rules of registration and examination of safety, quality and efficiency of medical devices, Feb. 12, 2016

Decree No. 162 – On adopting the rules for state registration, re-registration, an extension of the term of the certificate of the medicinal product in the Republic of Armenia

Official Language

Armenian and Russian

Classification

Class I, IIa, IIb and III

Registration Process

• Determine the device classification
• Appoint an Authorized Representative
• Prepare the Registration Dossier and submit it to the competent authority
• Once approved, the medical device can be marketed in Armenia.