Time Required: Preparing the required technical documentation, including clinical data, risk management plans, and quality management system evidence, can take several weeks to months depending on the complexity of the device and availability of data.

Performance Tracking: Manufacturers must implement a system to monitor the device’s performance in the market, including tracking adverse events and safety issues.

Entry to Market: Certification provides legal permission to market and distribute Class III medical devices in Russia. This is essential for compliance with local regulations and is required for any commercial activities within the country.

Class III Devices: These are considered high-risk due to their intended use or potential impact on patient health. They typically include devices that support or sustain life, prevent impairment of health, or present a potential risk of serious harm.

Regulations: Review the Federal Law on the Circulation of Medicines and Medical Devices, Roszdravnadzor guidelines, and other relevant Russian regulations.

Familiarize with Regulations: Review the Federal Law on the Circulation of Medicines and Medical Devices, Roszdravnadzor guidelines, and other relevant Russian regulations.

Documentation Preparation: Time needed to gather and prepare all required technical documentation, including device descriptions, clinical data, risk management plans, and quality management system (QMS) evidence.

Familiarize with Laws: Review Russian Federal Law on the Circulation of Medicines and Medical Devices and Roszdravnadzor guidelines.