For registering a Class I medical device with Roszdravnadzor (RZN) in Russia, you will need to prepare several important documents. These documents are required to ensure that your device complies with Russian medical device regulations and can be marketed in the country. Below is a list of the key documents required and guidance on how to prepare the application files.

Required Documents for Class I Medical Device Registration with RZN

1. Registration Application Form

• A completed registration application form must be submitted to Roszdravnadzor. This form can be filled out online via the Roszdravnadzor portal (http://www.rospotrebnadzor.ru/).
• The form includes information about the manufacturer, device description, intended use, and other relevant details.

2. Certificate of Free Sale (CFS)

• A Certificate of Free Sale (CFS) from the country of manufacture, demonstrating that the device is legally sold in the country of origin and complies with local regulatory standards.
• The CFS must be translated into Russian, and the translation must be notarized.
• It should be current, usually issued within the last 6 months.

3. Product Description

• A detailed description of the device, including:
  • Device name and model.
  • Intended use and indications.
  • Technical specifications, such as materials, dimensions, design, and functionality.
  • Classification information, confirming that it is a Class I medical device.
  • This document provides Roszdravnadzor with a complete understanding of what the device does and how it is intended to be used.

4. Instructions for Use (IFU)

• The user manual (IFU) must be submitted in Russian. It should include:
  • Device usage instructions, precautions, and warnings.
  • Contraindications, maintenance instructions, and troubleshooting guidelines.
  • Russian language is mandatory for all instructions.
• If the device is for professional use (e.g., in hospitals or clinics), the IFU should clearly indicate this.

5. Manufacturing Information

• Documentation regarding the manufacturer, including:
  • Name and address of the manufacturing company.
  • Details of the quality management system (e.g., ISO 13485 certification or equivalent).
  • Manufacturing process information and a declaration of conformity with safety standards.
• Good Manufacturing Practice (GMP) compliance is often required for medical devices.

6. Labeling Information

• The labeling of the medical device must comply with Russian regulations. This includes:
  • The name of the device and manufacturer.
  • Registration number, serial number, or lot number.
  • Storage conditions.
  • Expiration date (if applicable).
  • Russian language labeling is mandatory.
• In addition, the packaging should include safety information, warnings, and other labeling details that help users understand the proper use of the device.

7. Risk Management Documentation

• A risk management file should assess the risks associated with the device, especially if the device is related to patient safety.
• For Class I devices, this document will generally include basic risk assessments and management strategies to show that the device is safe for its intended use.

8. Clinical or Performance Data (If Applicable)

• For most Class I devices, clinical or performance data is not required, but this may vary depending on the device’s nature.
• In case the device has special features or requires testing, you may need to provide performance or safety data to demonstrate compliance.

9. Authorized Representative Agreement (If Applicable)

• If the manufacturer is based outside Russia, an authorized representative in Russia must be appointed to handle the registration process on behalf of the manufacturer.
• A signed agreement between the manufacturer and the authorized representative must be submitted, confirming the representative’s responsibility in the registration and post-market surveillance process.

How to Prepare the Application Files for Submission

1. Translate Documents into Russian

   • All required documents, including the product description, instructions for use, and labeling, must be translated into Russian. This ensures compliance with Russian regulations.
   • Translations should be performed by a certified translator and, in some cases, notarized for accuracy.
   • The Certificate of Free Sale and other official documents from your country must also be translated into Russian.

2. Compile the Documents in the Correct Format

   • Submit the documents in electronic format (typically PDF or Word) for online submission via the Roszdravnadzor portal.
   • Some documents may also need to be submitted in paper format, especially if Roszdravnadzor requests original copies.

3. Ensure Compliance with Russian Standards

   • Check that your labeling, instructions for use, and manufacturing documents meet the Russian GOST standards (or EAEU standards for devices sold in the Eurasian Economic Union countries).
   • Devices must be in compliance with Eurasian Economic Union (EAEU) technical regulations or Russian state standards (GOST).

4. Complete the Application Form

   • On the Roszdravnadzor portal, fill out the registration application form. This will include device information, manufacturer details, and the submission of your prepared documents.

5. Pay the Registration Fee

   • After submitting your application and documents, you will need to pay the registration fee. The fee can typically be paid via the portal or another approved method.

6. Submit the Application

   • Once everything is prepared and the fee is paid, submit the application and documentation to Roszdravnadzor via the online portal (or in paper form, if necessary).

7. Track Your Application

   • You can track the status of your application on the Roszdravnadzor portal and be notified of any additional information required.

Conclusion

To register a Class I medical device with Roszdravnadzor (RZN) in Russia, it’s important to ensure that all required documents are accurately prepared and meet Russian regulatory standards. This includes a completed application form, Certificate of Free Sale, product description, instructions for use (in Russian), manufacturing information, risk management data, and labeling details. For manufacturers based outside of Russia, appointing an authorized representative is a necessary step in the process. All documents must be translated into Russian and submitted either through the online portal or in paper form as per Roszdravnadzor’s requirements.