The Russian Ministry of Health has amended the procedure for monitoring the safety and efficacy of medical devices. The amendments are aimed at harmonizing with EAEU legislation and speeding up and systematizing the transfer of data on adverse incidents. The document has been registered with the Ministry of Justice and will come into effect on September 1, 2026.
Main innovations
1. Clarification of terminology and classification
The concept of “adverse event” now includes not only actual harm to health, but also the threat of harm, as well as instances of product malfunction identified during post-market surveillance. A classification of incident severity has been introduced according to IMDRF and EAEU standards: hospitalization, hospitalization prolongation, disability, life-threatening, and death.
2. Acceleration and digitalization of reporting
The deadline for submitting emergency notifications of serious incidents has been reduced to two calendar days (previously, five business days). Reporting is now electronic, accessible through the personal account on the Gosuslugi portal or the Medical Device Monitoring automated information system. Paper-based reporting is no longer prioritized, speeding up signal processing. Clear requirements for the structure of corrective action reports have been established (including a risk assessment and user communication plan).
3. Strengthening the role of the authorized representative
Foreign manufacturers are required to ensure the constant presence of an authorized representative in the Russian Federation with the authority to make safety decisions, including batch recalls. A 24/7 emergency communication channel from Roszdravnadzor is provided, and liability for violations has been personalized.
4. Focus on active monitoring and post-marketing data
Manufacturers must proactively collect data from registries and observational studies. If a risk signal is detected, a benefit-risk assessment must be initiated, even if no spontaneous complaints have been reported. Criteria for mandatory post-marketing clinical monitoring for implants and devices classified as risk class 3 have been clarified.
Business implications
– A two-day response time requires a well-established system for 24-hour reception and analysis of security signals.
– The transition to electronic interaction with the regulator requires the development of the IT infrastructure or staff training.
– Personal liability of managers increases the risk of sanctions, including suspension of registration.
Harmonization with EAEU rules simplifies the entry of products into the common market, but requires a uniform approach to safety monitoring in all countries of presence.
Failure to comply with the new requirements after September 1, 2026, could result in serious regulatory consequences.
