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The features of state registration of medical devices with a low degree of potential risk of their use are established.

Decree of the Government of the Russian Federation No. 199 of March 18, 2020 prepared a number of amendments to the Rules for the state registration of medical devices, established the features of registration of medical devices with a low degree of potential risk of use, and introduced a simplified procedure for their state registration. This applies to operating and insulating gowns, insulating suits, examination gloves, shoe covers, disposable masks to protect the respiratory tract, there are a total of 36 items (the full list can be found here). State registration of these products will be carried out in a shorter time. So, according to the changes, Roszdravnadzor will decide on the issue of a registration certificate for a medical device within 5 days after receiving from the applicant an initial package of documents (operational and technical documentation, an agreement of an authorized person, photos of products, an inventory of documents), and then within 150 days the applicant will have to provide a complete package of documentation for a medical device with protocols of clinical, technical, toxicological tests and other documents. Reducing the registration time is associated with the need to ensure the rapid introduction into circulation of medical devices used to prevent the spread of infectious diseases.