Requirements for Handling 3rd Class Medical Device RZN Registration in Russia

Registering a 3rd class (high-risk) medical device with Roszdravnadzor (RZN) in Russia requires adherence to stringent regulatory requirements. Below are the primary prerequisites and considerations for the registration process:

1. Appointment of a Local Authorized Representative

• Requirement: Foreign manufacturers must appoint a local authorized representative based in Russia.
• Role: The representative acts as the liaison between the manufacturer and Roszdravnadzor, submitting documentation, communicating with regulators, and ensuring post-market compliance.

2. Classification Confirmation

• Confirm that the medical device falls under Class 3, the highest-risk category, which includes devices used in life-critical or implantable scenarios. Examples: pacemakers, ventilators, implantable prosthetics.
• The classification is determined based on the device’s intended use, risk level, and interaction with the body.

3. Document Submission Requirements

Comprehensive documentation is essential to demonstrate the safety, efficacy, and quality of the device. The required documents include:

a. Administrative Documentation

• Application form signed by the authorized representative.
• Proof of appointment of the authorized representative.
• Manufacturer’s legal documents (e.g., registration certificates, ISO certifications).

b. Device Description and Technical Documentation

• Detailed description of the device: components, materials, and functions.
• Technical specifications and design details.
• Instructions for use and labeling in Russian.
• Packaging information and details about sterility (if applicable).

c. Clinical Data

• Clinical evaluation report demonstrating the safety and performance of the device.
• Results of clinical trials (if conducted in Russia) or equivalent data from other jurisdictions.

d. Quality Management System (QMS) Compliance

• Evidence of compliance with ISO 13485 or Good Manufacturing Practices (GMP).
• Manufacturing process details and quality assurance documentation.

e. Risk Analysis

• Comprehensive risk management documentation, such as a Risk Management Report following ISO 14971.
• Risk assessment methods, including potential hazards and mitigation strategies.

f. Certificates and Test Reports

• CE Mark or FDA approval certificate (if applicable).
• GOST-R compliance certificates (Russian technical standards).
• Test reports from accredited laboratories, confirming device safety and effectiveness.

4. Pre-Registration Clinical Trials (if applicable)

• In some cases, clinical trials in Russia are required for Class 3 devices, particularly if the device is new or has not been previously evaluated in similar markets.
• Trials must be conducted at accredited facilities and adhere to Russian clinical trial standards.

5. Laboratory Testing

• High-risk devices may require testing in Roszdravnadzor-accredited laboratories to ensure compliance with Russian safety and technical standards.
• This may include biocompatibility, electrical safety, and sterility tests.

6. Compliance with Russian Technical Standards

• The device must meet Russian GOST-R standards or equivalent technical specifications for materials, performance, and safety.
• Adaptation of labeling, instructions, and documentation to Russian norms is mandatory.

7. Manufacturing Site Inspection

• Roszdravnadzor may require an on-site inspection of the manufacturer’s facilities, especially for high-risk devices.
• This inspection ensures the manufacturer adheres to GMP and QMS standards.

8. Post-Market Obligations

After registration, manufacturers must fulfill post-market responsibilities:

• Adverse Event Reporting: Any malfunctions or adverse events must be reported to Roszdravnadzor.
• Periodic Safety Updates: Submission of updated clinical and safety data, if required.
• Product Changes: Notify Roszdravnadzor of any changes to the device, its labeling, or manufacturing processes.

9. Language Requirements

• All submitted documentation, including labels, instructions for use, and application forms, must be in Russian or translated into Russian by a certified translator.

10. Fees and Costs

• The manufacturer must pay the regulatory fees for the registration process. Fees vary based on the complexity and class of the device.
• Additional costs may arise from clinical trials, testing, and local representation services.

Key Takeaways

• Stringent Documentation: High-risk devices require comprehensive technical, clinical, and quality documentation.
• Local Representation: Non-Russian manufacturers must have a local authorized representative to manage the process.
• Compliance with Standards: Ensure the device complies with Russian and international technical and quality standards.
• Timeline: The registration process for Class 3 devices may take 6 to 12 months or longer, depending on the device’s complexity and completeness of the submission.

Proper preparation and collaboration with experienced regulatory consultants or authorized representatives can significantly streamline the RZN registration process.

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