Government regulation of the treatment of medical devices - problems improving the legal framework and enhancing the competitiveness of domestic production

Abstract

Existing legal framework regulating the management of medical devices is analyzed. Legal problems that hinder the development of production of medical devices are identified. Those rules and regulations that require improvement are denoted, including rules of state registration of medical devices, suggested consideration of the procedure of registration of medical devices depending on the class of risk. Nomenclature of the classifier of medical devices, harmonized with the global medical device nomenclature (GMDN) is widely discussed together with the draft of federal law «Management of medical devices» and a number of normative legal acts in the field of medical devices contained in the agreement of eurasian economic union.