To apply for Class 2A medical device registration in Russia with Roszdravnadzor (RZN), the process involves multiple steps, preparation of various documents, and specific considerations to ensure compliance with Russian regulations. Below is a detailed guide covering the steps, required materials, and important considerations.

Steps for Applying for Class 2A Medical Device Registration in Russia

1. Classify the Device and Determine Registration Requirements

• Class 2A classification: Verify that your device qualifies as a Class 2A medical device. Class 2A devices are typically low- to moderate-risk devices, such as diagnostic tools, therapeutic equipment, and devices with limited contact with the human body.
• Review the Russian Medical Device Classification Rules (which are in line with international standards) to confirm that the device falls under Class 2A.

2. Appoint a Local Representative (for Foreign Manufacturers)

• If you are a foreign manufacturer, you must appoint a local representative in Russia. This representative will handle the registration process on your behalf, ensuring that all required documentation is submitted correctly.
• The local representative must be a Russian legal entity (e.g., a distributor or regulatory affairs consultant) and should be authorized via a power of attorney.
• The power of attorney should be notarized and provided to the local representative, allowing them to act on your behalf.

3. Prepare Required Documentation

Preparing the required documentation is one of the most important steps. The documentation needs to demonstrate that the device meets Russian regulatory standards for safety, performance, and quality. The following documents are typically required:

a. Registration Application Form

• Complete the official registration application form available on the Roszdravnadzor portal. This form will ask for details about the manufacturer, device description, intended use, and other essential information.

b. Certificate of Incorporation

• A copy of the Certificate of Incorporation or other legal documents showing that the manufacturer is a valid legal entity.
• This document should confirm the legal status of the manufacturer and the authorization to market the device.

c. Certificate of Free Sale

• A Certificate of Free Sale from the country of origin or another market (e.g., EU, U.S.) indicating that the medical device is legally sold and used in the manufacturer’s home country or other markets.

d. Quality Management System (QMS) Certificate

• ISO 13485: A certificate demonstrating that the manufacturer has a Quality Management System (QMS) in place compliant with ISO 13485 standards for medical devices.
• For foreign manufacturers, the ISO 13485 certification should be issued by a recognized third-party certification body.

e. Technical Documentation (Technical File)

This is one of the most important sets of documents. It should demonstrate that the device is safe, effective, and compliant with Russian regulations. The technical file must include:

• Device Description: Detailed description of the device, its intended use, and how it works.
• Manufacturing Process: Information about how the device is manufactured, including descriptions of production and quality control.
• Risk Management: A risk analysis document in accordance with ISO 14971 to show how the manufacturer has identified and mitigated potential risks associated with the device.
• Clinical Data (If Applicable): Clinical trial data or performance data, if required, to show the device’s safety and effectiveness. For some Class 2A devices, clinical data might not be required, but if there are risks associated with the device, this data is crucial.
• Biocompatibility: Evidence that the device materials are safe for use, particularly for devices that come into contact with the human body (e.g., implants or diagnostic equipment).
• Packaging and Labeling: Information about the device's packaging, labeling, and instructions for use in Russian. This includes labeling in compliance with Russian regulations (e.g., Russian language requirements, regulatory symbols, etc.).

f. Declaration of Conformity

• Declaration of Conformity confirming that the device meets Russian standards, or if the device is manufactured in the EU, that it complies with CE marking requirements.

g. Product Samples (if applicable)

• Product samples may be requested by Roszdravnadzor for testing and evaluation. These samples should be representative of the final device being marketed.

4. Submit the Application

Once all documents are prepared, the next step is submitting the application. There are two ways to submit the application: online or by mail.

a. Online Submission via the Roszdravnadzor Portal

• Register on the Roszdravnadzor portal (Unified State Register of Medical Devices).
• Fill out the registration form, upload the required documentation, and submit the application electronically.
• You will need to pay the registration fee during the online submission process.

b. Mail Submission (if applicable)

• If submitting by mail, send the completed application form and all required documents to the Roszdravnadzor office.
  • Address: Federal Service for Surveillance in Healthcare (Roszdravnadzor), 11, 4th Veshnyakovsky Lane, Moscow, 109017, Russia.
• Ensure that you provide all necessary documents in both Russian and original language (if applicable).

5. Pay the Registration Fee

• Registration fees for Class 2A medical devices in Russia generally range from RUB 100,000 to RUB 300,000 (approximately USD 1,000 to USD 3,000).
• Fees must be paid at the time of submission, either online through the portal or as a part of the application package.
• The fee structure and payment methods can be found on the Roszdravnadzor website.

6. Roszdravnadzor Review and Evaluation

Once the application is submitted, Roszdravnadzor will review the documents and evaluate the medical device for compliance with Russian regulations. This process typically takes 6 to 12 months but can be faster or slower depending on various factors, such as the completeness of the application or the complexity of the device.

Potential Requests for Additional Information

• If Roszdravnadzor identifies gaps or issues in the application, they may request additional information or clarification. Be prepared to respond promptly to any such requests to avoid delays.

Inspection (if applicable):

• If you are a foreign manufacturer, Roszdravnadzor may require an inspection of your manufacturing facility to ensure compliance with Russian regulations, especially if no QMS certification is available.

7. Receive Registration Certificate

• If the review process is successful, Roszdravnadzor will issue a registration certificate, which grants authorization to market and sell the device in Russia.
• The registration certificate is typically valid for 5 years.
• After receiving the certificate, the device can be marketed and distributed in Russia. If necessary, renew the registration before it expires.

8. Post-Market Surveillance and Reporting

• After registration, the manufacturer (or local representative) must comply with post-market surveillance requirements, including monitoring the device’s safety and performance in the market.
• Report any adverse events or product recalls to Roszdravnadzor.
• Keep records of any complaints, issues, or recalls involving the device.

Considerations for Class 2A Medical Device Registration

• Russian Language: All documents, including labeling and instructions for use, must be translated into Russian. Ensure that translations are accurate and comply with Russian requirements.
• Local Representative: Foreign manufacturers must have a local representative in Russia to handle the registration process and manage communication with Roszdravnadzor.
• Regulatory Updates: Stay informed about any changes to Russian regulations for medical devices to ensure ongoing compliance.
• Risk Management: For devices that pose higher risks, even if classified as Class 2A, ensure that appropriate clinical data and risk management documentation are submitted.

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