The process for registering a Class 2A medical device in Russia with Roszdravnadzor (RZN) involves a series of structured steps to ensure the device complies with Russian regulations. Below is a detailed guide to the process:

1. Preliminary Steps

1.1. Device Classification

• Confirm that your device is classified as Class 2A under Russian regulations. Use the guidelines in TR CU 019/2011 (EAEU technical regulation for medical devices) to determine the classification.

1.2. Authorized Representative

• If you are a foreign manufacturer, appoint an Authorized Representative (AR) in Russia. The AR will act as the primary liaison with RZN and handle all regulatory communications.

2. Prepare the Required Documentation

Gather all necessary documents in accordance with Russian and EAEU requirements:

• Technical Documentation: Include device description, specifications, manufacturing processes, and intended use.
• Quality Management System (QMS) Certificate: Usually ISO 13485 or equivalent.
• Test Reports: Preclinical and clinical data proving safety and efficacy.
• Risk Analysis: Risk management documentation per ISO 14971.
• Labeling and Instructions for Use (IFU): Compliant with Russian language and GOST standards.
• Sample Device: If required for laboratory testing.

All documentation must be translated into Russian.

3. Testing and Expert Evaluation

3.1. Safety and Efficacy Testing

• Conduct testing for compliance with GOST and relevant TR CU 019/2011 standards. This includes:
  • Biological safety.
  • Electrical safety (if applicable).
  • Functional and performance testing.

3.2. Clinical Evaluation

• Submit existing clinical data or, if required, conduct local clinical trials in Russia. This is mandatory if the imported data does not meet RZN standards.

4. Submit the Application

4.1. Online Registration

• Register on the RZN online portal and upload the complete application package, including all required documents.

4.2. Submit Hard Copies

• Submit a hard copy of the application and supporting documents to RZN for validation.

5. Initial Review by RZN

RZN will:

• Evaluate Documentation: Verify the completeness and accuracy of the application package.
• Request Additional Information: If any documentation is missing or unclear, you must respond promptly.

6. Laboratory Testing by RZN

• RZN may conduct additional testing in accredited Russian laboratories to confirm compliance with applicable safety and performance standards.

7. Clinical Data Review

• RZN reviews clinical evidence submitted with the application or evaluates the results of local clinical trials.

8. Expert Panel Evaluation

• A panel of experts from RZN assesses the technical, clinical, and safety aspects of the device.

9. Registration Decision

• If the device meets all requirements, RZN will issue a Registration Certificate.
• If deficiencies are found, you may need to submit additional data or correct identified issues.

10. Post-Registration Obligations

• Label and package the product in compliance with Russian standards.
• Implement a Post-Market Surveillance (PMS) system.
• Maintain communication with RZN for periodic updates or device modifications.

Timeline

• The entire process can take 6 to 12 months, depending on the complexity of the device and the need for additional testing or trials.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn