Who needs a registration certificate for a medical device?

A registration certificate is required for all companies that plan to legally bring medical products to the Russian market. The registration obligation applies to both manufacturers and importers and suppliers, regardless of where the product was developed or manufactured.
Products that are used in the healthcare system and intended for medical purposes are subject to registration. We are talking not only about complex equipment, but also about consumables, software products and auxiliary tools, if they perform a medical function. In particular, registration is necessary in cases where the product is used for the diagnosis, treatment, prevention of diseases or medical rehabilitation of patients. It is also mandatory for products used in medical organizations, laboratories, clinics and other healthcare institutions.
Special attention is paid to products that come into contact with the human body. This applies both to direct contact, for example with skin, mucous membranes or blood, and indirect interaction through biological media. This category includes invasive and implantable products, as well as consumables used during medical procedures. Regardless of the duration of contact, such products are considered by the regulator as potentially affecting patient safety and require registration.
Medical products are also recognized as products that include software if it is used for medical purposes. If a software product is involved in the diagnosis, treatment, or monitoring of a health condition, it is subject to registration along with physical products.
At the same time, registration is also required for products that are intended for the sterilization of medicines and medical devices. This category also includes products for the storage and transportation of biological materials.
Another group of products that require a registration certificate is the monitoring of human physiological parameters. These are products designed to measure blood pressure, pulse, oxygen levels in the blood, temperature and other parameters used to assess the state of health. Products designed to replace or alter anatomical structures must also be officially registered.
If the product meets at least one of the listed criteria, it qualifies as a medical device and is subject to state registration. The registration procedure involves the preparation and examination of technical and operational documentation, mandatory testing and the formation of a registration dossier. Only after completing all the stages and obtaining a registration certificate can the product be legally put into circulation on the territory of the Russian Federation.