In accordance with the Government Decision No. 1795-N of the Republic of Armenia, dated November 24, 2022, expert evaluations and professional inspections in the field of state regulation of the circulation of medical devices (hereinafter referred to as MD) are conducted by the State Non-Profit Organization (SNPO) "Center of drug and medical technology expertise" of the Ministry of Health of the Republic of Armenia. The provisions for the regulation of MD circulation in Armenia are outlined in Chapter 10 of the Law of the Republic of Armenia on "Medical Assistance and Healthcare Services to the Population."
"Medical devices" refer to any instrument, apparatus, equipment, materials, and other products that are used for medical purposes either individually or in combination, as well as accessories necessary for the intended use of these products (including special software), which the manufacturer has intended for the prevention, diagnosis, treatment, medical rehabilitation, and monitoring of the human health status, conducting medical research, restoration, replacement, or alteration of the anatomical structure or physiological functions of the body, prevention or artificial termination of pregnancy, and whose functional purpose is not achieved through pharmacological, immunological, genetic, or metabolic interaction with the human body, although this may be assisted by pharmaceuticals.
Medical devices intended for in vitro diagnosis refer to any instrument, apparatus, equipment, materials, reagents, control standards, test substances, and other products used for medical purposes either individually or in combination, as well as the necessary accessories and special software required for their intended use, which the manufacturer has intended for use in in vitro testing of human biological samples to determine physiological or pathological conditions (congenital pathology, predisposition to a certain clinical condition or disease), tissue compatibility with a potential recipient, prediction of reactions to therapeutic effects, selection of therapeutic agents and (or) monitoring of treatment.
