The process for applying for Class I medical device registration with Roszdravnadzor (RZN) in Russia involves several key steps. These steps ensure that the device complies with the necessary regulations and is eligible for sale and distribution within Russia.

Here is a breakdown of the steps involved in applying for Class I medical device registration with RZN:

Step 1: Determine if Your Device Qualifies as Class I

• Class I Medical Devices are low-risk devices that do not require clinical trials or extensive evaluations. Ensure that your device falls within this category according to the Russian Medical Device Classification criteria, which is based on risk levels, intended use, and the product’s characteristics.

Step 2: Appoint an Authorized Representative (for Foreign Manufacturers)

• If you are a foreign manufacturer, you must appoint an authorized representative in Russia. This authorized representative will serve as your liaison with RZN and will handle the registration process on your behalf.
• The authorized representative must be based in Russia and registered with Roszdravnadzor.

Step 3: Gather Required Documentation

Prepare the following documents for submission:

1. Application Form:

   • Complete the registration application form as specified by Roszdravnadzor.

2. Technical Documentation:

   • Detailed description of the device, including design, intended use, and how it functions.
   • Manufacturing process, raw materials, and technical specifications.
   • Safety and performance data, including any testing reports or international certifications (such as ISO 13485, if applicable).

3. Declaration of Conformity:

   • A document confirming that the device complies with Russian technical regulations (TR 027/2012) and international standards.

4. Quality Management System (QMS):

   • If applicable, evidence of compliance with a quality management system, such as ISO 13485, which ensures the device is manufactured to required standards.

5. Device Labeling:

   • Ensure the device labeling is compliant with Russian regulations. Labels must be in Russian and include information such as product name, manufacturer details, intended use, and safety instructions.

6. User Instructions:

   • Provide a manual in Russian that explains how to use the device properly and safely.

7. Other Documents:

   • Importer’s or distributor’s details, if applicable.
   • Certificate of Free Sale or equivalent documents confirming that the device is legally marketed in other countries, if applicable.

Step 4: Submit the Application to Roszdravnadzor

• Submission:

  • Submit the completed application and all supporting documentation to Roszdravnadzor.
  • The submission can be made through the RZN online portal (if available), or by submitting hard copies directly to the RZN office.
  • The application will undergo an initial review to ensure all documentation is in order.

• Fees:

  • There may be a registration fee depending on the type of device and the specific process. Ensure that the payment is made at the time of submission if applicable.

Step 5: Review by Roszdravnadzor

• Initial Review:

  • RZN will first verify that the documentation is complete and that it meets the Russian regulatory requirements for medical devices.
  • If any information is missing or unclear, RZN will request additional documents or clarification.

• Detailed Evaluation:

  • RZN will conduct a thorough review of the technical documentation, including the device’s safety and performance data, risk assessment, labeling, and compliance with the relevant standards.
  • In some cases, RZN may request additional tests or information, but this is less common for Class I devices.

Step 6: Issuance of Registration Certificate

• Certificate of Registration:

  • After RZN completes the review and confirms that the device meets all requirements, it will issue a registration certificate.
  • The registration certificate will include details such as the device name, the manufacturer's name, the authorized representative (if applicable), and the classification of the device (Class I).
  • The certificate is required to legally market and distribute the device in Russia.

• Validity:

  • The registration certificate for Class I devices is generally perpetual, meaning there is no need for renewal unless there are significant changes to the device, such as modifications to its design, materials, or intended use.

Step 7: Post-Registration Compliance

• Market Surveillance:

  • After registration, ensure that the device remains in compliance with post-market surveillance requirements. This includes monitoring the device’s performance, reporting any adverse events, and keeping up-to-date with any regulatory changes.

• Adverse Event Reporting:

  • If any serious adverse events related to the device occur, they must be reported to Roszdravnadzor within specific timeframes as outlined by the regulations.

• Changes to the Device:

  • Any changes to the device (e.g., modifications in design, manufacturing process, or labeling) must be notified to Roszdravnadzor, and re-registration may be required for significant changes.

Step 8: Ongoing Regulatory Updates

• Keep track of changes in regulations and standards that may affect your device’s compliance with Russian medical device requirements. Regularly check for updates from Roszdravnadzor or consult with your authorized representative to stay informed.

Summary of the Steps for Applying for Class I Medical Device Registration with RZN:

1. Determine Class I Eligibility: Confirm that the device qualifies as a low-risk medical device.
2. Appoint Authorized Representative: If a foreign manufacturer, appoint a local representative in Russia.
3. Prepare Documentation: Gather the necessary technical documents, including safety data, labeling, and quality management certifications.
4. Submit Application: Submit the complete application and documents to Roszdravnadzor, including any applicable fees.
5. RZN Review: Roszdravnadzor reviews the application for completeness and compliance.
6. Receive Registration Certificate: Once approved, receive the registration certificate that allows the device to be marketed in Russia.
7. Post-Registration Compliance: Ensure ongoing compliance with surveillance and reporting requirements after registration.

By following these steps, you can navigate the registration process for Class I medical devices in Russia successfully.

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