[The shortcomings of technical regulation in sphere of circulation of medical devices for diagnostic in vitro in the Russian Federation: the state of affairs and proposed solutions].

The article presents analysis of international and national trends in area of development of normative legal documents in sphere of circulation of medical devices for diagnostic in vitro. The comparative analysis was made concerning certain principles of formation of nomenclature of medical devices for diagnostic in vitro in the international practice and in the Russian Federation. The necessity of reformation of national normative legal base in this issue is demonstrated.