Understand Requirements: Familiarize yourself with the Federal Service for Surveillance in Healthcare (Roszdravnadzor) requirements for Class III devices.

Pre-Application Preparation: Ensure your device meets Russian regulations and standards. Prepare necessary documents such as technical specifications, clinical data, and quality management system certificates.

Documentation Preparation: Gathering and preparing all required technical documentation and translations can take several weeks to a few months, depending on the complexity of the device and completeness of the documentation.

Regulatory Updates: While an annual review specifically is not mandated, your device must remain compliant with any changes in Russian regulations and standards. This involves staying updated on regulatory changes and ensuring ongoing adherence to current requirements.

Entry to Russian Market: Certification is mandatory for legally marketing and selling medical devices in Russia. It grants you access to this large and growing market.

Document Preparation: Gathering and preparing all required technical documentation, translations, and supporting materials can take several weeks to a few months, depending on the complexity of the device and the completeness of your documentation.

Regulatory Approval: RZN certification is an official approval required for medical devices to be marketed and sold in Russia. It ensures that the device complies with Russian regulations, standards, and safety requirements.

Technical Regulations: Review the Technical Regulations of the Customs Union (TR CU 020/2011) and any additional Russian standards relevant to Class C medical devices.