Russia Shifts to Risk-Based Medical Device Oversight with New Roszdravnadzor Model

On 28 November 2025, Russia implemented significant changes to its medical device regulatory oversight system managed by the Federal Service for Surveillance in Healthcare (Roszdravnadzor). Roszdravnadzor updated its approach to compliance inspection and market surveillance by introducing a risk-based model with preventive visits and formal remote supervision requirements.

This regulatory shift marks a departure from routine scheduled inspections in favour of a more targeted oversight framework that categorises market players according to risk and adapts supervision frequency accordingly. The adjustments apply to any entity operating in the Russian medical device market, including manufacturers, importers, distributors, storage facilities, and clinical investigation sponsors.

Key Features of the New Oversight Model

Under the updated framework, Roszdravnadzor has reconfigured its inspection system to focus on risk and preventative engagement rather than periodic, scheduled reviews. The risk categories now include a new High-Risk tier, which draws in products and operators presenting elevated risks to safety or public health.

Mandatory preventive visits have replaced many traditional inspections, with oversight tailored based on assigned risk level. Remote supervision facilitated through tools such as video conferencing and the Inspector mobile application is now formally authorised, reflecting broader digital integration in regulatory practice.

Another important aspect of the reform is the codification of specific procedural safeguards. Companies subject to oversight now have defined appeal windows, including a five-business-day appeal period for risk category assignments and a fifteen-business-day period for other regulatory decisions.

Implications for Industry Participants

This new approach has practical implications across the lifecycle of medical devices in Russia:

For Manufacturers: Entities must understand their assigned risk category and anticipate preventive engagement intervals. Compliance documentation, quality management systems, and internal records should be ready for review via both in-person visits and remote sessions.

For Importers and Distributors: Companies handling logistics, warehousing, distribution, or sales should be prepared to support regulatory inquiries at scheduled preventive touchpoints. Communication channels with Roszdravnadzor should be clear, and traceability systems must be robust.

For Clinical Investigation Sponsors: Sponsors conducting studies within Russia need to confirm that their activities, records, and reporting mechanisms align with the risk-based oversight framework. Procedures for adverse event reporting and trial documentation should meet updated expectations.

A Modernised Model for Market Surveillance

Moving to a risk-based oversight system aligns with broader global regulatory trends, where agencies allocate resources and attention according to the potential impact of non-compliance. By emphasising preventive engagement and enabling remote supervision, Roszdravnadzor aims to enhance both regulatory reach and operational efficiency without over-burdening entities that maintain high standards of compliance.

This transition also reflects a regulatory intent to embrace digital tools and remote methodologies in enforcement activities a trend seen in many mature regulatory systems internationally. For companies operating in the Russian medical device ecosystem, adapting to these mechanisms will be critical for ongoing compliance and uninterrupted market access.

Conclusion and Outlook

The implementation of the risk-based model by Roszdravnadzor represents a notable development in Russia’s medical device regulatory landscape. As the regulatory environment continues to evolve, industry stakeholders must familiarise themselves with these changes and build the necessary capacities to respond effectively to preventive visits and remote supervision activities.

Understanding risk categorisation, preparing proactive compliance strategies, and establishing responsive systems will be key to navigating this updated oversight framework. With these changes now in effect, companies are encouraged to review internal processes and ensure readiness for this modernised approach to market surveillance.

Source: Russia Medical Device Inspections: New Risk-Based Preventive Visits and Remote Oversight Model by Roszdravnadzor (effective November 28, 2025)