To apply for 2A class medical device registration in Russia with Roszdravnadzor (RZN), you need to follow a series of steps to ensure compliance with Russian and Eurasian Economic Union (EAEU) regulations. Below is a comprehensive guide outlining the procedures:

Step-by-Step Procedures for Registration

1. Preliminary Preparation

1. Device Classification

   • Confirm that the device falls under Class 2A according to the Russian TR CU 019/2011 technical regulation for medical devices. This classification determines the requirements for testing and documentation.

2. Appoint an Authorized Representative (AR)

   • If you are a foreign manufacturer, you must appoint a local Russian Authorized Representative. The AR will handle communication with RZN and submit the application on your behalf.

3. Prepare Required Documentation

   • Gather all necessary documents (translated into Russian), including:
     • Technical documentation.
     • Test reports.
     • Clinical evaluation report.
     • Quality Management System (QMS) certificate (ISO 13485 or equivalent).
     • Risk management documentation.
     • Labels and Instructions for Use (IFU) in Russian.

2. Conduct Initial Testing

1. Safety and Performance Testing

   • Perform testing in accredited laboratories to meet standards under GOST and TR CU 019/2011.
   • Tests may include:
     • Biological safety.
     • Electrical safety (if applicable).
     • Functional and mechanical performance.

2. Clinical Evaluation or Trials

   • Submit clinical data demonstrating the safety and efficacy of the device.
   • If necessary, conduct local clinical trials approved by RZN.

3. Submit the Application

1. Online Registration

   • Register on the RZN portal to create an account and submit the application electronically.

2. Submit Hard Copies

   • Provide a hard copy of the application and supporting documents to RZN’s central office.

3. Pay the Application Fee

   • Ensure payment of the applicable fee to initiate the review process.

4. RZN Review and Testing

1. Documentation Review

   • RZN verifies the completeness and accuracy of the submitted application.
   • If additional documents or corrections are needed, you will receive a formal request.

2. Laboratory Testing

   • RZN may conduct further testing in its accredited facilities to confirm compliance with technical and safety standards.

3. Clinical Data Review

   • Submitted clinical data is evaluated for compliance with Russian and EAEU requirements.

5. Expert Panel Evaluation

• A panel of experts reviews all test results, clinical evaluations, and technical documentation to assess whether the device meets regulatory standards for safety and performance.

6. Registration Certificate Issuance

1. Approval
   • If all requirements are met, RZN issues a Registration Certificate for the device.
2. Rejection or Revisions
   • If deficiencies are found, RZN may reject the application or require additional data for reconsideration.

Post-Approval Obligations

After receiving the Registration Certificate:

1. Labeling Compliance

   • Ensure all product labels and Instructions for Use (IFU) are updated to meet Russian language and regulatory standards.

2. Post-Market Surveillance (PMS)

   • Implement a system for monitoring the device’s performance and reporting adverse events to RZN.

3. Periodic Updates

   • Notify RZN of any significant changes to the device design, manufacturing process, or intended use.

Estimated Timeline

The registration process typically takes 6–12 months, depending on:

• The complexity of the device.
• Whether additional testing or clinical trials are required.
• The completeness and quality of the submitted documentation.

Key Considerations

• Translation Accuracy: Ensure all documents are professionally translated into Russian to avoid delays.
• Authorized Representative: The AR plays a critical role in liaising with RZN and ensuring compliance.
• Compliance with EAEU Standards: Align the device with both Russian and EAEU technical and safety requirements.

By following these procedures and maintaining clear communication with RZN, you can successfully apply for Class 2A medical device registration in Russia.

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