To obtain RZN certification for Class 2b medical devices in Russia, you need to meet specific regulatory requirements set by the Federal Service for Surveillance in Healthcare (Roszdravnadzor). Here’s a detailed overview of these requirements:

1. Classification and Device Information

Class 2b Classification

• Definition: Class 2b devices are medium-risk medical devices, which means they require a comprehensive evaluation to ensure safety and effectiveness.
• Examples: Devices that have a moderate risk to patients, such as certain diagnostic equipment, infusion pumps, and other similar devices.

2. Documentation Requirements

Technical File

• Product Description: Detailed information about the device’s intended use, design, and operation.
• Design and Manufacturing Information: Details of the device’s design, production processes, and quality control procedures.
• Performance Data: Evidence showing how the device performs in its intended use, including lab test results and performance studies.

Clinical Evidence

• Clinical Trials: Data from clinical trials or studies demonstrating the safety and effectiveness of the device.
• Clinical Evaluation Report: A comprehensive report summarizing the clinical data, including any adverse effects or risks.

Quality Management System (QMS)

• ISO 13485 Certification: Evidence of compliance with ISO 13485 or equivalent standards, which demonstrate the manufacturer’s ability to consistently meet regulatory requirements and ensure product quality.
• QMS Documentation: Detailed documentation of the manufacturer’s quality management system, including procedures, processes, and records.

Labeling and Instructions for Use

• Russian Language: Labels and user instructions must be translated into Russian and comply with local regulations.
• Content Requirements: Must include device name, manufacturer details, intended use, warnings, and usage instructions.

International Certifications

• Proof of Compliance: If the device is certified in other countries (e.g., CE mark, FDA approval), provide copies of these certifications as evidence of compliance with international standards.

3. Application Process

Submission of Application

• Application Form: Complete the application form provided by Roszdravnadzor or through a local representative.
• Documentation: Submit the technical file, clinical evidence, QMS documentation, labeling, and any international certifications.
• Fees: Pay the required application fees. The amount may vary based on the device and the specific certification process.

Local Representation

• Authorized Representative: Although not always mandatory, having a local Authorized Representative or distributor in Russia can facilitate the certification process and help navigate regulatory requirements.

4. Evaluation and Inspection

Technical Evaluation

• Document Review: Roszdravnadzor will review the submitted documentation to ensure it meets regulatory standards.
• Requests for Additional Information: Be prepared to provide additional data or clarifications if requested by Roszdravnadzor.

Factory Inspection

• On-Site Inspection: For Class 2b devices, an inspection of the manufacturing facility may be required. This inspection assesses the compliance of manufacturing processes and the quality management system.

5. Certification Issuance

Decision

• Certification: If the device meets all requirements, Roszdravnadzor will issue the RZN certificate. This certificate is necessary for marketing and selling the device in Russia.

6. Post-Certification Requirements

Compliance

• Ongoing Surveillance: Maintain compliance with Russian regulations, including post-market surveillance, reporting adverse events, and ensuring ongoing quality.
• Documentation Updates: Keep all documentation up-to-date and notify Roszdravnadzor of any significant changes to the device or manufacturing processes.

Renewal

• Certificate Renewal: Be aware of the certificate’s expiration date and initiate renewal processes as needed.

Additional Considerations

• Language and Translation: Ensure all documentation is translated into Russian and complies with local requirements.
• Regulatory Changes: Stay informed about any changes in Russian regulations that could affect your certification status.
• Consult Experts: Engage with regulatory consultants or local representatives to navigate the certification process effectively.

Resources

• Roszdravnadzor: The official website of the Federal Service for Surveillance in Healthcare provides detailed guidelines and contact information.
• Regulatory Consultants: Specialized consultants can assist with preparing documentation and ensuring compliance with Russian regulations.

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