Before applying for Class I medical device registration with Roszdravnadzor (RZN) in Russia, it’s important to make thorough preparations to ensure that the device and all necessary documentation meet Russian regulatory requirements. Proper preparation can help streamline the registration process and reduce the likelihood of delays or rejections. Below are the key steps and considerations to make before you apply for Class I medical device registration in Russia:

1. Verify Device Classification

• Confirm the Classification: Ensure that the device qualifies as a Class I medical device according to EAEU Technical Regulation No. 036/2016 (TR EAEU 036/2016) and Russian regulations. Class I devices are typically low-risk, but confirming the correct classification is critical for applying the correct regulatory pathway.
• Review Classification Criteria: Class I devices typically don’t require clinical trials or extensive safety data, but you should verify the exact classification based on the intended use, risk level, and functionality of the device.

2. Appoint a Local Authorized Representative (If Applicable)

• If your company is located outside of Russia, appoint a Russian authorized representative who will be responsible for submitting the registration application and communicating with Roszdravnadzor on your behalf.
• The authorized representative will need to be registered with Roszdravnadzor and will need to sign legal documents related to the device registration.
• Ensure the authorized representative is well-versed in Russian regulatory processes and is able to manage communications with local authorities.

3. Develop Comprehensive Technical Documentation

The technical documentation is the backbone of the registration process. It should be thorough and well-organized to meet the requirements of Roszdravnadzor. Key documents to prepare include:

• Product Description:

  • Name, model, and version of the device.
  • Intended use and indications for use.
  • Components, materials, and functions of the device.
  • Manufacturing processes and details about the production facility.

• Risk Management Documentation:

  • Even for low-risk Class I devices, provide basic risk analysis to show that the device does not pose undue risks to patients or users.

• Instructions for Use (IFU):

  • A comprehensive user manual in Russian detailing how to use the device, safety warnings, contraindications, and maintenance instructions.

• Labeling:

  • Ensure the device label is compliant with Russian regulations, including the manufacturer’s details, serial numbers, expiry date (if applicable), and any relevant safety information.

• Quality Management System (QMS):

  • If your company is certified to ISO 13485, include your ISO 13485 certificate and any relevant documentation demonstrating that the device is manufactured in compliance with good manufacturing practices (GMP).

• Biocompatibility Testing (if applicable):

  • For devices in contact with skin, mucous membranes, or other parts of the human body, prepare biocompatibility data or evidence that the materials used are safe.

• Compliance with Russian Standards:

  • Confirm that the device meets relevant GOST (Russian national) standards. This may include testing reports or certifications from recognized laboratories.

4. Prepare Documentation for Legal and Regulatory Compliance

• Certificate of Free Sale (CFS):

  • If your device is marketed in other countries, prepare a Certificate of Free Sale from the country of origin, indicating that the device is legally sold and available in that market.
  • The CFS must be translated into Russian and notarized if applicable.

• Authorization from Manufacturer:

  • If the manufacturer is a foreign company, ensure that the manufacturer provides official authorization for the Russian authorized representative to handle the registration.

• Manufacturer's Declaration:

  • A declaration confirming that the device complies with all applicable EAEU and Russian regulations for medical devices, including safety, performance, and risk management standards.

5. Ensure Compliance with Russian Regulations and Standards

• GOST Standards:

  • Ensure that the device complies with Russian GOST standards, which are equivalent to the ISO standards used in other countries. For Class I devices, the primary focus will be on GOST R 50444-99 for medical device safety and performance.

• EAEU Technical Regulations:

  • Ensure the device complies with the EAEU Technical Regulation No. 036/2016, which governs the safety and performance of medical devices across the Eurasian Economic Union (EAEU) member states, including Russia.

• ISO 13485 Certification:

  • If applicable, ensure the manufacturing facility holds ISO 13485 certification, as this will demonstrate that the manufacturer follows internationally recognized quality management practices for medical devices.

• Biological Safety and Risk Assessment:

  • Prepare a risk management plan, and if necessary, include biological safety data for materials in contact with the body. Compliance with ISO 10993 or similar standards may be required, especially for devices in direct contact with patients.

6. Translation and Notarization of Documents

• Russian Language Requirement:
  • All documents submitted for registration must be in Russian. This includes the product description, user manual, labeling, risk assessment, and any other regulatory documents.
  • Use certified translators for legal and technical documents, and notarize translations where required (e.g., for the Certificate of Free Sale).
• Notarization:
  • For key documents like the Certificate of Free Sale, manufacturer’s authorization, and any other official declarations, you will need to notarize the translations to ensure they are legally recognized by Roszdravnadzor.

7. Verify Importation and Distribution Channels

• Import Documentation:
  • If the device will be imported into Russia, ensure that you are prepared with importation documents, such as customs declarations and import permits. These are necessary for bringing the device into the country legally.
• Distribution Compliance:
  • Ensure that your distribution partners in Russia are aware of their responsibilities, including proper storage, handling, and distribution practices in compliance with Russian medical device regulations.

8. Be Prepared for a Potential Audit

• On-Site Inspections:
  • Roszdravnadzor may require an on-site inspection of the manufacturing facility as part of the registration process or after the device is registered. Ensure that your manufacturing processes, quality management systems, and risk management practices are in compliance with Russian regulations.
• Facility Documentation:
  • If applicable, prepare documentation related to the manufacturing facility, such as ISO 13485 certificates, GMP compliance, and records of internal audits.

9. Review Regulatory Fees and Payment Process

• Registration Fees:
  • Be aware of any fees associated with the registration process. Roszdravnadzor may charge for the processing of the registration application and other related services.
• Payment Methods:
  • Ensure you know the official methods for submitting payments to Roszdravnadzor, as they typically require payments to be made via specific channels (bank transfer, etc.).

10. Submit the Application

• Once all the required documents are in place, submit the application through the Roszdravnadzor electronic portal (if applicable) or by sending the necessary paper documentation directly to Roszdravnadzor.
• Ensure that the application is complete and that all required documents are included to avoid delays.

Summary Checklist for Preparation

1. Verify the device classification as a Class I medical device.
2. Appoint a Russian Authorized Representative (if applicable).
3. Prepare technical documentation, including product descriptions, risk analysis, and labeling.
4. Ensure compliance with GOST and EAEU regulations for safety, performance, and risk management.
5. Prepare legal documents such as the Certificate of Free Sale and authorization from the manufacturer.
6. Translate and notarize all documents in Russian.
7. Verify importation and distribution channels in Russia.
8. Be prepared for potential audits or facility inspections.
9. Review regulatory fees and payment processes.
10. Submit the application to Roszdravnadzor and track the registration process.

By thoroughly preparing and ensuring all documents and processes are in place, you can help ensure a smooth registration process for your Class I medical device in Russia.

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