Classification: Class 2b devices are considered medium-risk medical devices in Russia. These devices typically have a higher degree of risk compared to Class 1 and 2a devices and require more rigorous evaluation.

Website: The official website of Roszdravnadzor provides comprehensive information on the certification process and application forms.

Definition: Class 2b devices are medium-risk medical devices, which means they require a comprehensive evaluation to ensure safety and effectiveness.

The RZN (Russian Ministry of Health) certification process for Class 2b medical devices involves several key steps. This certification ensures that the medical device complies with Russian regulations, which is crucial for its marketing and sale in Russia.

RZN certification, also known as registration with the Russian Ministry of Health, is a mandatory process for medical devices intended for use in Russia. For Class 2b medical devices, which are considered medium-risk devices, the certification ensures that the product meets safety, quality, and efficacy standards as required by Russian regulations.

Class 2b Devices: These are considered medium-risk devices. The requirements for Class 2b devices are more stringent compared to Class 1 and 2a devices. Ensure your device fits the classification before proceeding.

GOST R: Russian national standards that may include requirements for medical devices. These standards are periodically updated to align with international practices.

Research Regulations: Familiarize yourself with Russian regulations for medical devices, including Federal Law No. 61-FZ and Roszdravnadzor guidelines.