Regulatory changes at both the international and national levels in recent years have been aimed at improving safety in the use of medical devices while maintaining a balance between the interests of business, the state and patients. Innovations are characterized by a common vector, include:the formation of a conceptual apparatus, a unified nomenclature of medical products, optimization of the interaction of all subjects of treatment, taking into account the specifics of individual groups of medical products; improvement of control mechanisms, intensification of the fight against the presence of falsified, unregistered and other potentially dangerous medical products in civil circulation, while reducing the administrative burden on business; increasing the level of security at the post-registration stage, first of all, by strengthening the role of manufacturers of medical products.Further improvement of the regulatory framework aimed at preventing, identifying and preventing risks to the life and health of patients the use of medical devices, and minimizing the consequences of their occurrence remains one of the most important tasks.