Scientific development of 3D bioprinting is rapidly advancing. Bioprinting is expected to be actively implemented within the healthcare industry producing a revolutionary impact on transplantation. However, the innovative biotechnology involves numerous ethical and regulatory issues. Special attention is given to ethical issues associated with the use of embryonic cells, storage of personal data, obtaining informed consent, and peculiarities of clinical trials. The issues of safety and quality are reviewed. Equal access to technologies and use of biotechnologies to ‘enhance a human being’ are addressed. The issues of culture and religion are separately discussed within the context of this technology. It is stressed that as far as the issue of ethical estimation and legal regulation goes, 3D bioprinting can’t be completely assessed with the help of regular clinical trials or acting regulatory requirements. In particular, no suitable regulatory system or special documents regulating 3D bioprinting of tissues and organs and their subsequent transplantation are currently available in Russia or globally. Thus, it’s necessary to develop requirements to safety, quality and effectiveness of technological processes and end products obtained with the help of 3D bioprinting with the best interests of generally acknowledged human rights.