A draft order of the Federal Service for Surveollance in Healthcare was posted on the legal information web-site. The document contains the requirements to the information on non-original components necessary for the maintenance of medical devices and on their manufacturers, as well as to the technical documentation, its scope and content. All information must be entered in the appropriate register. In addition, a special form has been developed by which it is possible to decide whether a particular component can be used as a component that is not provided by the manufacturer of the medical device.
The order is expected to come into force on September the 1st, 2023. Its validity will tentatively last until January the 1st, 2025.
According to the order, the manufacturer will be required to attach photos, technical and operational documentation for spare parts to the application, including a passport, operation, installation, adjustment and dismantling manuals, as well as a letter confirming the consent of the component manufacturer to use its product as part of a medical device and readiness to accept all risks associated with causing harm to the product, other equipment, personnel and patients due to the design features of a non-original component.
The considered register of such components for the maintenance and repair of medical devices will contain a number of information necessary for maintaining the corresponding database. At the moment, an approximate list of registered information has been established: the name and model (modification) of the product, information about the manufacturer, including contact information of authorized persons, purpose, matter and conditions of use, a list of registered medical devices in which the component can be used, indicating registration information, a list of original components (with name, model, etc.) that can be replaced by a non-original product, information about compatible software versions (for products that include software), the date this information was provided.
Based on this information, the Federal Service for Surveillance in Healthcare will form a conclusion on whether it is possible to use the proposed components for specific medical devices. This measure is aimed at developing the own Russian production of spare parts for medical equipment, as well as at simplifying the export and use of foreign analogues produced in friendly countries. Thus, the supervisory authorities are trying to mitigate the impact of sanctions on the industry with minimal risk of using components that are not provided for in the documentation, and at the legal level.
As an example of the relevance of this project, specialized tubes for computed tomography devices are used. Although the tubes themselves are not considered medical devices, they are used everywhere and have a service life of up to 13 years. However, in practice, wear occurs faster and tubes fail in less than two years in some cases. This leads to downtime of tomographs and the need for rapid replacement of components.
The main manufacturers of such tubes for equipment used in Russia are the USA, Japan, the Netherlands, Italy and Germany. In the current period, these countries have applied certain packages of sanctions against the Russian Federation, and therefore it is necessary to find a replacement for these components with the appropriate characteristics in other countries or develop their own production of analogues.
Nevertheless, registration of X-ray tubes as medical devices, which they are not, is impossible, and therefore the Federal Service for Surveillance in Healthcare made a sensible decision to control both the medical devices themselves and their components and consumables.
Not so long ago, the Federal Service for Surveillance in Healthcare announced the possibility of replacing such components in agreement with VNIIIMT and successfully passing all tests, including the test for compatibility with a medical device. With the appearance of the draft order, it can be said that the initiative was successful and will help to avoid problems with a shortage of medical equipment or with downtime for repair and maintenance of failed or in need of updating products.
Previously, the Russian Federation has already taken measures to reduce the impact of sanctions on the medical sphere: the procedure for registering medical devices has been simplified and accelerated, especially for those that may be in short supply due to problems with supplies and timely service. The registration period has been reduced to 22 days, and it has become easier to make changes to the registration dossier. In addition, it was proposed to export certain categories of medical devices for repair. Taken together, these relaxations allow us to hope for the development of the domestic medical industry.
