Steps and Process for 3rd Class Medical Device RZN Registration in Russia

Registering a Class 3 medical device with Roszdravnadzor (the Russian Federal Service for Surveillance in Healthcare) involves a detailed and multi-step process to ensure the safety, efficacy, and compliance of the device. Below is a step-by-step guide to the process for registering a Class 3 medical device in Russia.

1. Confirm Device Classification

• Class 3 medical devices are high-risk devices, such as those intended for life support, critical care, or that pose significant risks to the patient if malfunctioning. Make sure your device is classified under Class 3 according to the Russian Medical Device Classification System.
• Examples: Pacemakers, defibrillators, ventilators, implantable devices, etc.

2. Appoint a Local Authorized Representative in Russia

• Foreign manufacturers must have a local authorized representative in Russia to manage the registration process. The representative will submit the application, communicate with Roszdravnadzor, and manage the post-registration compliance.
• The representative is a legal entity based in Russia that is officially recognized by the Russian authorities.

3. Gather Required Documentation

The documentation required for Class 3 device registration is comprehensive and will need to be prepared well in advance. The required documents include:

a. Registration Application Form

• Complete the official application form provided by Roszdravnadzor. This form includes basic details about the manufacturer, the device, and its intended use.

b. Technical Documentation

• Device description: Detailed technical information about the device, including materials, design, components, function, and intended use.
• Device labeling: Labels, instructions for use, and packaging information in Russian.
• Manufacturing information: Proof of compliance with quality management systems (e.g., ISO 13485) and good manufacturing practices.
• Risk assessment: A risk management report detailing potential risks associated with the device, including Failure Mode and Effects Analysis (FMEA) or Hazard Analysis.

c. Clinical Data

• Clinical evaluation: Provide data showing the safety and efficacy of the device, either from clinical trials or other studies (e.g., CE clinical data). The clinical data is critical for Class 3 devices.
• If clinical trials are conducted in Russia, include the results of these trials.

d. Test Reports and Certificates

• CE marking (if applicable): If the device is already CE marked, submit the CE certificate and the relevant technical file.
• GOST-R compliance (if applicable): Ensure the device complies with Russian standards (GOST-R).
• ISO certifications: If available, provide documentation proving compliance with ISO 13485 or other relevant standards.

e. Manufacturing Site Documentation

• Information on the manufacturing site, including a Certificate of GMP (Good Manufacturing Practices) or other relevant certifications confirming the quality of production.

4. Submit Application to Roszdravnadzor

• Electronic Submission: The application and all required documents are submitted through the Roszdravnadzor online portal or directly via your authorized representative in Russia.
• If the manufacturer is based outside Russia, they must rely on their local representative to handle the submission process.

5. Expert Review and Evaluation by Roszdravnadzor

Once the application is submitted, Roszdravnadzor will evaluate the documents. The review process can involve the following:

a. Technical Expertise

• Roszdravnadzor may request a technical review of the device. This will include reviewing the device’s technical file, clinical data, risk analysis, and manufacturing compliance.

b. Additional Testing or Data (if necessary)

• If Roszdravnadzor finds any gaps in the submission or requires further verification, additional testing or studies may be requested.
• For some devices, testing may need to be conducted in Russia or accredited laboratories recognized by Roszdravnadzor.

c. On-Site Inspection (if applicable)

• On-site inspection of the manufacturer’s facility may be required, especially for high-risk Class 3 devices. Roszdravnadzor will assess whether the manufacturer complies with required standards, such as GMP.

6. Issuance of Registration Certificate

• If the evaluation is successful and no issues are found, Roszdravnadzor will issue the registration certificate for the device.
• The registration certificate is valid for 5 years from the date of issuance. After this period, a renewal application will need to be submitted.

7. Post-Market Surveillance and Compliance

After the device is registered, the manufacturer must comply with Russia’s post-market surveillance regulations, which include:

a. Reporting Adverse Events

• Reporting any adverse events or device malfunctions to Roszdravnadzor as per Russian regulations.

b. Periodic Safety Updates

• Providing periodic safety reports and clinical data updates if required.

c. Renewal of Registration

• The device registration is valid for 5 years. After this period, it must be renewed by submitting updated documentation, including data on the device’s continued safety and effectiveness.

Timeline and Fees

• Timeline: The entire process for registering a Class 3 medical device can take from 6 months to 1 year or more, depending on the complexity of the device and the completeness of the submitted documentation.
• Fees: The registration process involves fees, which vary based on the device’s class and complexity. Fees are typically higher for Class 3 devices than for lower-risk devices.

Key Points to Remember

• Authorized Representative: A local representative in Russia is mandatory for foreign manufacturers.
• Language: All documents must be provided in Russian or officially translated.
• Compliance with Russian Standards: Ensure compliance with Russian GOST-R and other relevant standards.
• Clinical Data: Essential for Class 3 devices, particularly if the device is novel or does not have prior clinical approval in another jurisdiction.
• Post-Market Surveillance: Ongoing compliance with Russian medical device regulations is required after the device is registered.

By following these steps and ensuring all required documentation is complete and accurate, you can successfully navigate the Russian regulatory process for Class 3 medical devices. Working with an experienced local representative or regulatory consultant can greatly simplify the process.

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