The process of registering a Class I medical device with Roszdravnadzor (RZN) in Russia involves several key steps, which are designed to ensure the safety, efficacy, and quality of the medical device being introduced into the Russian market. Class I devices are typically low-risk devices that do not require extensive clinical trials or complex procedures, but still must comply with the regulatory framework to ensure consumer safety. Here's a step-by-step guide to the registration process for a Class I medical device:

1. Pre-Registration Preparation

• Determine Classification of the Device:

  • Confirm that your device is classified as Class I. RZN typically classifies medical devices based on their risk, and Class I devices are low-risk.
  • Class I medical devices generally include items like bandages, simple diagnostic devices, and medical tools that do not have an invasive function.

• Establish Authorized Representative in Russia (for foreign manufacturers):

  • If you are a foreign manufacturer, appoint an authorized representative or importer who is registered with RZN and has a legal presence in Russia. This representative will handle the registration process on your behalf.
  • Ensure that your representative is responsible for ensuring compliance with all regulatory requirements and is capable of communicating with the regulatory authorities.

• Gather Necessary Documentation:

  • Prepare all relevant documentation, including:
    • Technical Documentation: Specifications, descriptions, and details of the device, including risk analysis and instructions for use.
    • Quality Management Documentation: Proof of compliance with international standards such as ISO 13485 (Quality Management Systems for Medical Devices).
    • Labeling Information: Ensure that your labeling is in compliance with Russian requirements (in Russian), including safety symbols, instructions for use, and contact details of the manufacturer or authorized representative.
    • Manufacturer's Declaration of Conformity: A statement confirming that the device complies with applicable regulations and standards.

2. Prepare the Registration Dossier

• Compile the Registration Application:

  • The registration application includes details such as the device name, classification, manufacturer information, description of the device, and evidence of compliance with applicable technical and quality standards.
  • Ensure that the technical file includes detailed information on:
    • Design and intended use of the device.
    • Materials used in manufacturing.
    • Results of any performance or safety testing.
    • Risk assessment reports.

• Complete the Declaration of Conformity:

  • For Class I devices, you typically need to submit a Declaration of Conformity stating that the device complies with Russian regulatory requirements.
  • This may include meeting the Technical Regulations (such as TR 027/2012) for medical devices and adhering to GOST R 50444 standards.

• Ensure Labeling Compliance:

  • Labels must comply with the requirements of the Russian technical regulations, which include the use of the CE mark (if applicable), appropriate safety symbols, product identifiers, and instructions in the Russian language.

3. Submit the Registration Application to RZN

• Submission of Documents:
  • Submit the complete registration application and all supporting documents to Roszdravnadzor (RZN) through their electronic registration portal or directly via paper submission (depending on the latest process as determined by RZN).
  • The submission should include:
    • Application form filled out according to RZN’s template.
    • Technical documentation, including safety and performance data.
    • Declaration of Conformity.
    • Labeling and packaging details.

4. RZN Review and Evaluation

• Initial Review:
  • RZN will review the submitted application and verify whether all required documents are complete and meet Russian medical device standards.
  • They may request additional information or clarification regarding the device or the manufacturer.
• Approval Process:
  • If the device complies with all regulatory requirements, RZN will grant approval for the registration.
  • For Class I devices, the approval process is typically faster and more straightforward compared to higher-risk device classes, as there is no need for clinical trials or extensive testing.

5. Notification of Registration

• Certificate of Registration:
  • If the review is successful and the device is approved, RZN will issue a certificate of registration for the Class I medical device.
  • This certificate confirms that the device is authorized for sale and distribution in Russia.
• Registration Duration:
  • For Class I devices, the registration is usually perpetual, meaning there is no need for periodic renewals unless there are significant changes to the device (e.g., design changes, manufacturing process updates).

6. Post-Registration Obligations

• Market Surveillance:
  • Once the device is on the market, the manufacturer or authorized representative must ensure compliance with post-market surveillance requirements, including monitoring for adverse events or safety issues.
• Adverse Event Reporting:
  • Any serious incidents, adverse events, or device failures must be reported to Roszdravnadzor within the required timeframes.
• Compliance with New Regulations:
  • Stay informed about any updates to Russian medical device regulations or EAEU harmonization efforts that may impact the device’s status or require updates to labeling, safety reports, or technical documentation.

7. Additional Considerations

• Changes in the Device:
  • If the device undergoes significant changes (e.g., a change in materials, intended use, or manufacturing process), the manufacturer must notify Roszdravnadzor and, if necessary, submit an updated application for approval.
• Importation and Distribution Compliance:
  • If your device is being imported into Russia, you must ensure that all importation documentation is complete, including customs declarations, to avoid delays in bringing the device to market.

Summary of Steps Involved in Class I Medical Device Registration with RZN:

1. Determine Classification: Confirm the device is Class I and establish an authorized representative (for foreign manufacturers).
2. Prepare Documentation: Gather technical documentation, risk assessments, labeling, quality management certificates (e.g., ISO 13485), and Declaration of Conformity.
3. Submit Application: Submit the registration application and supporting documents to Roszdravnadzor via their electronic portal or paper submission.
4. RZN Review and Evaluation: RZN evaluates the application and may request additional information or clarification.
5. Notification of Approval: Upon approval, receive the Certificate of Registration from RZN, authorizing the device for sale in Russia.
6. Post-Registration Compliance: Comply with post-market surveillance, adverse event reporting, and ensure ongoing compliance with any new regulations or standards.

Key Takeaways:

• The registration process for Class I devices is relatively straightforward compared to higher-risk devices.
• Manufacturers or authorized representatives must ensure all required documentation is complete and compliant with Russian regulations.
• The registration certificate allows for the device to be sold in the Russian market, but ongoing monitoring, compliance, and reporting are crucial for maintaining market access.

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