Research Regulations: Familiarize yourself with the Technical Regulation on Medical Devices (TR 020/2011) and other relevant Russian regulations to understand the requirements for Class 2b devices.

Monitoring and Reporting: Implement a post-market surveillance system to monitor the device's performance and safety once it is on the market. Report any adverse events or incidents to Roszdravnadzor as required.

Technical Regulation on Medical Devices (TR 020/2011): This is the primary regulation governing medical devices in Russia. It outlines general safety and performance requirements, including device design, manufacturing practices, and clinical evaluation.

General Information: A detailed description of the medical device, including its intended use, design, functionality, and how it achieves its intended purpose.

Initial Review: The initial review of the application and documentation typically takes 1 to 2 months. During this period, Roszdravnadzor assesses the submitted documents for completeness and compliance with regulatory requirements.

Device Classification: Confirm that the device is correctly classified as Class 2b under Russian regulations. Class 2b devices are medium-risk and require detailed documentation.

Technical File: Device description, design, manufacturing details, and performance data.

Device Description: Detailed information on the medical device, including its intended use, design, functionality, and components.