In October 2026, Roszdravnadzor began mass-suspending registration certificates for medical devices. The reason: manufacturers and their authorised representatives failed to submit post-registration clinical monitoring (PCM) reports. According to the service's letters dated October 13 alone, 47 medical devices were subject to suspension — and this appears to be only the beginning.
Who has been affected by the new wave
The suspension affects the most complex and critical product categories — Class 3 medical devices and implantable Class 2b devices. It is precisely for these that an updated safety monitoring procedure has been in force since September 1, 2026, approved by Ministry of Health Order No. 541n of May 26, 2026. This document replaced the previous Order No. 1113n, and one of the key changes is that reports are now accepted exclusively through the Roszdravnadzor automated information system (AIS). A "lost" document can no longer be blamed on postal delays — the fact of submission is recorded in the system.
What exactly is required of manufacturers
The obligation to conduct post-registration clinical monitoring and report on it existed before, but it is in 2026 that the regulator has moved to the practice of mass suspensions. For Class 3 devices and implantable Class 2b devices, monitoring is conducted during the first three years after market entry, and this period may be extended by decision of the regulator. Reports must be submitted annually, no later than February 1, in electronic form via the AIS.
What difficulties manufacturers have encountered
According to specialists working in PCM, the main problem is dependence on clinics. The obligation to organise monitoring lies with the manufacturer or its authorised representative, but this does not give automatic access to clinical data. It is necessary to negotiate what information to collect, which physicians are responsible for it, and how to transmit the information, and, in the case of long-term observation, how to obtain long-term results. Sometimes data is collected under a commercial contract; sometimes cooperation rests on the professional interest of physicians — either way, the system has to be built independently.
The second difficulty is a lack of practical experience. Even when a company knows that a report is required, employees do not always understand how to build the system: which indicators to choose, which forms to prepare for physicians, how to verify the completeness of data. It is especially difficult for authorised representatives of foreign manufacturers, who need to build interaction with Russian clinics from scratch.
What happens if the violation is not remedied
Suspension of registration is not just a halt in sales. If the violation is not remedied within the established period, the regulator has the right to fully annul the registration certificate. For Class 3 devices and implantable Class 2b devices, this means an effective withdrawal of the product from the market — with the impossibility of supplying clinics, participating in public procurement, and continuing clinical practice.
How Elibrium helps to overcome the new barrier
In a context where the absence of a PCM report becomes a direct cause of registration suspension, it is critically important to build the monitoring system before the regulator sends a notification.
At Elibrium, we help manufacturers and their authorised representatives organise post-registration clinical monitoring in accordance with the new requirements:
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we analyse whether your device falls under mandatory PCM and within what timeframes;
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we develop a monitoring programme taking into account the specifics of the device and its risk class;
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we help build interaction with medical organisations for collecting clinical data;
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we prepare reports in the format corresponding to the requirements of Order No. 541n;
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we ensure submission of reports through the Roszdravnadzor AIS;
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we advise on extending monitoring periods and interacting with the regulator.
We operate transparently: timelines and costs are fixed in the contract.
Post-registration monitoring is no longer a formality. Elibrium offers a route where risks are calculated and reporting meets the requirements of 2026.
Contact us through our website, and our specialists will assess your project and prepare a tailored offer.
