Republic of Armenia - MedStandard
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Republic of Armenia

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  • Regulatory Authority:

“Scientific Center of Expertise of Medicines and Medical Technologies named after Academician E.Gabrielyan” CJSC, Ministry of Health of the Republic of Armenia

  • Language:

Armenian, Russian

  • Registration period:

6–8 months

  • Legislations:

Decree of the Government of the Republic of Armenia dated 30 March 2023, No.429 “On Approval of the Procedure for Importation of Medical Devices into the Territory of the Republic of Armenia and the List of Required Documents for the Expert Examination Conducted for the Purpose of Importation of Medical Devices”

  • Authorized Representative:

country resident

A brief algorithm for registration of medical devices in Republic of Armenia:

01
01

Medical device classification determination

02
02

Appointment of an Authorized representative

03
03

Preparation and submission of the registration dossier to the Regulatory Authority

04
04

After obtaining marketing authorization, the medical device can be sold

Final price and terms procedures will be calculated according to your request