In accordance with the Law of the Republic of Armenia “On Medical Care and Services to the Population”, during the transitional period established by the Law, until 31 December 2027, the circulation of unregistered medical devices is permitted in the territory of the Republic of Armenia alongside medical devices registered in the Republic of Armenia.During this transitional period, the regulation of medical device importation in the Republic of Armenia will continue to be carried out in accordance with Government Decision No. 429 of March 30, 2023.
During this transitional period, the regulation of the importation of medical devices into the Republic of Armenia shall continue to be carried out in accordance with Government Decision No. 429-N of 30 March 2023
In accordance with Government Decision No. 429-N of 2023 (hereinafter referred to as the “Decision”), in order to obtain a certificate for the import (conformity) of medical devices into the Republic of Armenia, legal entities and individual entrepreneurs importing medical devices, or persons authorized by them, shall submit an electronic application through the “Single Window for Foreign Trade of the Republic of Armenia” electronic system, attaching scanned color copies of the documents specified in Annex 2 of the Decision in PDF format.
For the expert assessment required for the importation of unregistered medical devices, the following documents shall be submitted:
a. document confirming authorization (state registration) for use in the country of manufacture or in member countries of the International Medical Device Regulators Forum (e.g., EU, Russia, USA, Canada), or a justified reference thereto; including a Declaration of Conformity with references to relevant registries;
b. quality certificate for each batch of imported medical devices (e.g., final inspection report, lot release certificate, batch release certificate, certificate of analysis, or other equivalent document issued by the manufacturer or its authorized representative, indicating the batch/lot number);
c. the instructions for use (IFU) of the medical device or a link to its electronic version;
d. Clear color images or diagrams of the medical device showing its labeling, where information contained on the labeling is required during the expert assessment.
In accordance with this Decision, the import of used medical devices is not permitted, except in cases where they are refurbished, provided that the period from their date of manufacture to the time of import does not exceed 5 years, and the import is carried out on the basis of documents issued by the manufacturer or its authorized technical service organization. These documents must include a description of the refurbishment works performed, as well as a conclusion confirming compliance with safety, quality, and performance requirements after completion of such works (certificate, declaration, final testing report, or equivalent document).
The import (conformity) certificate is issued as a one-time import permit for a single import into the territory of the Republic of Armenia. The certificate is valid for one year and becomes void after customs clearance of the goods.