In the Republic of Armenia, clinical and clinical-laboratory investigations of medical devices are regulated by Article 47 of the Law of the Republic of Armenia “On Medical Care and Services to the Population” and the relevant subordinate legislation.

Authorization to conduct clinical investigations of medical devices and interventional clinical-laboratory investigations (studies) of medical devices intended for in vitro diagnostic purposes to evaluate their performance is granted by the Ministry of Health of the Republic of Armenia through approval of the investigation (study) protocol and accompanying documents, based on a positive expert opinion issued by the Expert Organization and a positive opinion of the Ethics Committee for Clinical Investigations (Studies).

Pursuant to Decision No. 1795-N of the Government of the Republic of Armenia dated 24 November 2022, examinations and professional assessments in the field of state regulation of the circulation of medical devices are carried out by the “Center of Drug and Medical Technology Expertise” State Non-Commercial Organization of the Ministry of Health of the Republic of Armenia.

In the case of clinical investigations (studies) of medical devices intended for in vitro diagnostic purposes (except for interventional studies for the evaluation of their performance), as well as medical devices that are software, the competent authority shall be notified, in accordance with the procedure established by law, at least 10 days prior to the commencement of such investigations (studies).

In the Republic of Armenia, clinical and clinical-laboratory investigations (studies) of medical devices are planned and conducted in accordance with the requirements established by Decision No. 29 of the Council of the Eurasian Economic Commission dated 12 February 2016.

For the purpose of obtaining authorization to conduct clinical investigations of medical devices and interventional clinical-laboratory investigations (studies) of medical devices intended for in vitro diagnostic purposes to evaluate their performance, the manufacturer of the medical device under investigation or its authorized representative submits an application to the Ministry of Health of the Republic of Armenia, together with the package of documents specified in Paragraph 53 of Decision No. 29 of the Council of the Eurasian Economic Commission dated 12 February 2016.

The Ministry of Health of the Republic of Armenia grants authorization to conduct clinical investigations of medical devices and interventional clinical-laboratory investigations (studies) of medical devices intended for in vitro diagnostic purposes to evaluate their performance, based on a positive expert opinion issued by the Expert Organization and a positive opinion of the Ethics Committee for Clinical Investigations (Studies), in accordance with the procedure established by Decision No. 29 of the Council of the Eurasian Economic Commission dated 12 February 2016.