The processing time for applying for Class I medical device registration with Roszdravnadzor (RZN) in Russia is typically shorter compared to higher-class devices due to the lower risk profile of Class I devices. However, the timeline can vary depending on several factors, including the completeness of your application, the complexity of the device, and any follow-up requests from RZN for additional information.

Typical Processing Time:

• Class I medical device registration generally takes between 1 to 3 months from the submission of the application to the issuance of the registration certificate.
• This relatively quick timeline is due to the simpler regulatory requirements for Class I devices, which do not require clinical trials or extensive technical evaluations.

Stages of the Review Process:

The registration process with RZN for a Class I medical device typically involves the following stages:

1. Pre-Submission Stage (Preparation)

• Timeframe: Varies depending on preparation.
• Activities:
  • Determine that the device qualifies as a Class I device under Russian regulations.
  • Prepare all necessary documentation, including:
    • Technical documentation (product description, intended use, materials, etc.).
    • Risk assessment and safety information.
    • ISO 13485 certification (if applicable).
    • Labeling and user instructions in Russian.
    • Declaration of Conformity.
    • Appointment of an authorized representative (if a foreign manufacturer).
  • Verify that all documents meet the RZN's standards for submission.

2. Submission Stage

• Timeframe: Typically 2–5 days for submission.
• Activities:
  • Submit the registration application and supporting documents through RZN's online portal (or paper submission if applicable).
  • Include the completed application form, technical documentation, Declaration of Conformity, and other required documents.
  • RZN may charge an application fee, depending on the device's classification and other factors.

3. Initial Review by RZN

• Timeframe: 5–10 working days.
• Activities:
  • RZN will conduct a preliminary review of the submitted application to ensure that all necessary documentation is complete and that the device meets basic regulatory standards.
  • If the submission is incomplete, RZN may issue a request for additional information or clarification.
  • RZN will confirm whether the device qualifies as a Class I medical device and that the supporting documentation aligns with the regulatory requirements.

4. Detailed Review and Evaluation

• Timeframe: 15–30 working days (may vary depending on complexity).
• Activities:
  • RZN will evaluate the technical documentation, ensuring that the device complies with Russian Technical Regulations (e.g., TR 027/2012) and international standards (such as ISO 13485).
  • RZN may request additional clarifications or documentation if necessary.
  • This stage may also include verifying product labeling and ensuring that it complies with Russian language requirements and safety standards.

5. Issuance of Registration Certificate

• Timeframe: 5–10 working days after review completion.
• Activities:
  • If the device meets all regulatory requirements, RZN will issue a registration certificate confirming that the device is authorized for distribution and sale in Russia.
  • This registration certificate will include details about the device, its classification, and the authorized representative (if applicable).

6. Post-Registration Compliance (Ongoing)

• Timeframe: Ongoing after approval.
• Activities:
  • After registration, the manufacturer or authorized representative must comply with post-market surveillance requirements, including reporting adverse events, conducting risk assessments, and submitting annual safety updates if applicable.
  • Any changes to the device (e.g., modifications to design, materials, or labeling) will require a notification or re-submission to RZN.

Summary of the Stages and Estimated Timeframes:

1. Pre-Submission Preparation: Varies (depends on document readiness).
2. Submission of Application: 2–5 days.
3. Initial Review by RZN: 5–10 working days.
4. Detailed Review and Evaluation: 15–30 working days.
5. Issuance of Registration Certificate: 5–10 working days.
6. Post-Registration Compliance: Ongoing.

Factors Affecting Processing Time:

• Completeness of Documentation: If your application is complete and meets all requirements, the process will be faster. Incomplete or non-compliant applications may lead to delays.
• Requests for Additional Information: If RZN asks for additional clarification or missing documents, this can extend the review period.
• Workload of RZN: Processing time can also vary depending on the volume of applications RZN is handling at a given time.

While the timeline is generally 1–3 months for Class I devices, it’s always advisable to monitor the progress through the RZN portal and ensure all documentation is up to date and compliant with Russian regulations.

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