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Legislation

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  1.  The Law of the Republic of Armenia on "Medical Assistance and Healthcare Services to the Population" — the provisions for the state regulation of the circulation of medical devices in the Republic of Armenia are defined in Chapter 10,

  2. Agreement on "Unified Principles and Rules for the Circulation of Medical Devices (Medical Purpose Products and Medical Technology) within the Framework of the Eurasian Economic Union" dated December 23, 2014,

  3. The Law of the Republic of Armenia on "State Duty",

  4. The Law of the Republic of Armenia on "Licensing" ,

  5. Decision No. 429-N of the Government of the Republic of Armenia on "The Procedure for Importing Medical Devices into the Territory of the Republic of Armenia and the List of Documents Required for Expert Evaluation of Medical Device Imports",

  6. The EAEU Regulation on the Registration of Medical Devices, step-by-step registration process guide,

  7. The EAEU Regulation on the Registration of Medical Devices: "Rules for the Registration of Medical Devices and the Examination of Their Safety, Quality, and Effectiveness" — Decision No. 46 of the Eurasian Economic Commission Council dated February 12, 2016, step-by-step registration process guide,

  8. Decision No. 867 of the Government of the Republic of Armenia dated June 29, 2002, on "The Rules for Licensing the Production of Medicines, Pharmaceutical Activities, the Provision of Medical Assistance and Services by Organizations or Individual Entrepreneurs, Wholesale Distribution of Medicines, Production of Medical Devices, and the Maintenance of Medical Devices, and the Forms of Licenses for Such Activities", which defines the licensing procedures for the production and servicing of medical devices.

  9. Decision No. 29 of the Eurasian Economic Commission Council on "Rules for Clinical and Clinical-Laboratory Trials (Research) of Medical Devices" dated February 12, 2016,

  10. The regulatory acts and decisions of the Eurasian Economic Commission (EEC) governing this sector are available on the official EEC website, and they are also published in Armenian on the arlis.am platform.