Obtaining RZN certification for Class 2b medical devices in Russia involves several steps to ensure compliance with regulatory requirements. Here’s a detailed overview of the process:

1. Pre-Application Preparation

a. Understand Regulatory Requirements

• Research Regulations: Familiarize yourself with the Technical Regulation on Medical Devices (TR 020/2011) and any relevant Russian standards.
• Consult Guidelines: Review guidelines issued by Roszdravnadzor, the Federal Service for Surveillance in Healthcare.

b. Prepare Technical Documentation

• Technical File: Compile a comprehensive technical file that includes device description, design, manufacturing information, performance data, clinical evaluations, and risk management documentation.
• Translate Documents: Ensure all documents are translated into Russian by a certified translator.

c. Quality Management System (QMS)

• ISO 13485: Ensure compliance with ISO 13485 or an equivalent standard. Implement and document a robust Quality Management System.
• Prepare QMS Documentation: Prepare documentation related to your QMS, including procedures, policies, and records.

2. Application Preparation

a. Appoint an Authorized Representative

• Authorized Representative: If your company is not based in Russia, appoint a local Authorized Representative (AR) who will act on your behalf for regulatory matters.

b. Complete the Application Form

• Application Form: Fill out the RZN application form accurately, including all required details about the device and your company.

c. Prepare Required Documents

• List of Required Documents: Gather all necessary documents, including:
  • Technical documentation
  • QMS documentation
  • Clinical and performance testing data
  • Device labeling and instructions for use
  • Proof of payment for application fees

3. Submission of Application

a. Submit Application to Roszdravnadzor

• Submission: Submit the completed application form and all required documents to Roszdravnadzor. This can be done through their online portal or via physical submission, depending on the current process.

b. Application Fees

• Payment: Pay the applicable application fees and include proof of payment with your submission.

4. Review and Evaluation

a. Document Review

• Initial Review: Roszdravnadzor will review the submitted documents for completeness and compliance with Russian regulations.

b. Technical Evaluation

• Evaluation: The device may undergo technical evaluation to assess its safety and effectiveness. This could involve additional documentation, testing, or expert consultations.

c. On-Site Inspection

• Facility Inspection: An inspection of the manufacturing facility may be conducted to verify compliance with quality and safety standards.

5. Certification Decision

a. Issuance of Certificate

• Certification: If the device meets all requirements, Roszdravnadzor will issue the RZN certification for your Class 2b medical device.

b. Certificate Validity

• Validity Period: The certification will be valid for a specific period, usually five years. Ensure you are aware of the expiry date and prepare for renewal in advance.

6. Post-Certification Requirements

a. Post-Market Surveillance

• Monitor Device: Implement a post-market surveillance system to monitor the device’s performance and safety in the market.
• Report Adverse Events: Report any adverse events or incidents to Roszdravnadzor as required.

b. Regulatory Updates

• Stay Informed: Keep up-to-date with any changes in regulations or standards that may affect your device.

c. Product Changes

• Notify Changes: Inform Roszdravnadzor of any significant changes to the device, including modifications or updates, and submit updated documentation if necessary.

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