Regulatory Legal Acts Pertaining to the Transplantation and Manufacture of Medical Devices from Human Organs and Tissues

Abstract

The need to include specialized norms of modern Russian law in legislation governing the manufacture of medical devices from human biological material is considered on the example of normative legal acts regulating relations. A retrospective analysis of the development of legal regulation in the field of the use of human biomaterial in medicine, reveals the origins of the discussed issue. Current legislation in the Russian Federation in the field of organ and tissue donation for the purposes of transplantation and the use of human biological material for the production of medical devices is examined taking a specialized legal approach. A current lack of legal regulation in this area is revealed. While some issues associated with the use of human biomaterial for the manufacture of medical devices are fixed at the level of by-laws, the production of medical devices and biofabricated products is hindered by a lack of legal regulation in these areas of contemporary medicine. Required improvements in the legal foundations of regenerative and reconstructive medicine in the Russian Federation will involve the development of an independent federal law that includes norms and definitions for delimiting the provisions of regenerative and reconstructive medicine in related fields of medicine. As well as distinguishing between basic concepts in the fields of replacement-, regenerative- and reconstructive medicine, the definitions of these concepts must be consolidated in normative legal acts. Proposed definitions related to medical technologies and the use of human biomaterial are presented in the form of a new terminological glossary of innovative technologies involving the use of human biological material.