On September 1, 2026, two orders of the Russian Ministry of Health came into force, regulating the medical device safety monitoring system:
– Order No. 540n of May 26, 2026 — establishes the procedure for monitoring the safety of medical devices;
– Order No. 541n of May 26, 2026 — defines the procedure for reporting adverse events during the circulation of products in Russia and other countries.
Both documents are valid until September 1, 2032. Order No. 541n replaces the previously existing procedure (Order No. 1113n), and No. 540n replaces Order No. 980n.
Major changes
– Structured monitoring. According to Order No. 540n, monitoring encompasses the collection, processing, recording, and analysis of product safety data. Sources of information include those involved in the circulation of medical devices, as well as individuals using the devices.
– Regulations for reporting adverse events. Order No. 541n establishes the procedure for reporting all adverse events identified during the product’s circulation to Roszdravnadzor. Notifications are sent via Roszdravnadzor’s automated information system no later than 20 business days from the date of detection.
– Expanding the scope of responsible parties. The responsibility for reporting now falls not only on the manufacturer but also on the party that identified the adverse event. The process may involve an authorized representative, supplier, seller, healthcare organization, and other participants, depending on who identified the event. This clarifies the distribution of responsibility throughout the entire chain of custody.
– Detailed requirements for the content of the notification. The notification must include information about the medical device and its manufacturer; registration certificate; model, version, series, or serial number; potential risk class; number of devices in circulation; location and circumstances of the event; the person who used the device and the injured person; a description of the event and its consequences; actions taken and the current status of the situation. The notification format is provided in the appendix to Order No. 541n.
– Additional notifications. If new information about an adverse event emerges after the initial data transfer, additional notification must be sent to Roszdravnadzor.
Important clarification:
Order No. 540n does not apply to medical devices registered in accordance with international treaties and acts constituting EAEU law. Therefore, when assessing the applicability of these requirements, it is necessary to consider the regulatory regime under which a specific device is registered.
