Registration of medical masks

Registration of medical masks in the Russian Federation is a prerequisite for their legal circulation on the market. If a product is declared as a medical device and is intended for medical, preventive, or sanitary-epidemiological purposes, it automatically belongs to the category of medical devices and is subject to state registration. Medical masks are classified as low-risk products, but this does not exempt them from registration. A low risk class affects only the scope of the examination and the list of tests, but does not cancel the obligation to obtain a registration certificate.
The registration procedure includes preparation of the registration dossier, conducting tests and expert evaluation of the submitted materials. The applicant forms the technical documentation, which specifies the purpose of the product, its design and technical characteristics, the materials used, the production conditions, as well as instructions for use. After that, the medical mask is tested in accredited laboratories, where its safety and compliance with the declared characteristics are confirmed.
Based on the submitted documents and test results, Roszdravnadzor conducts an expert examination. If the decision is positive, a registration certificate is issued, after which the product can be put into circulation. The standard period for state registration is up to 50 working days, excluding the time spent on testing and possible documentation improvements.
However, after receiving the registration certificate, medical masks must be correctly labeled, have the specified registration number, and be accompanied by instructions for use. Russia has a state system for monitoring the circulation of medical products, which provides for accounting and traceability of products, including medical masks, within the established requirements.