The time required to obtain RZN certification for Class 2b medical devices in Russia can vary depending on several factors, including the complexity of the device, the completeness of the submitted documentation, and the current workload of Roszdravnadzor. Generally, the process can take several months. Here’s a breakdown of the typical timeline and the review process involved:

Timeline for RZN Certification

1. Preparation Phase: 1-3 Months

   • Document Preparation: Preparing technical documentation, ensuring compliance with quality management standards, and translating documents into Russian.
   • Quality Management System: Ensuring ISO 13485 compliance and preparing QMS documentation.
   • Pre-Submission Review: Internal review of documents and application materials to ensure completeness and accuracy.

2. Application Submission: 1-2 Weeks

   • Submission of Application: Actual submission of the application form, technical documentation, and proof of payment to Roszdravnadzor.

3. Review and Evaluation Phase: 2-6 Months

   • Initial Document Review: Roszdravnadzor reviews the submitted documents for completeness and compliance. This may take several weeks.
   • Technical Evaluation: Detailed technical evaluation of the device’s safety and effectiveness. This step might include additional requests for information, testing, or expert consultations.
   • Facility Inspection: If required, an inspection of the manufacturing facility is conducted to verify compliance with quality and safety standards. The scheduling and completion of the inspection can impact the overall timeline.

4. Certification Issuance: 1-2 Weeks

   • Decision Making: Roszdravnadzor makes a decision based on the review and evaluation. If all requirements are met, the certification is issued.
   • Certificate Issuance: Once approved, the RZN certification is issued and provided to the applicant.

Review Process for RZN Certification

1. Application Review

   • Document Completeness: Roszdravnadzor reviews the application form and accompanying documents to ensure they are complete and accurate.
   • Compliance Check: The review assesses whether the submitted documentation complies with Russian regulations and standards.

2. Technical Evaluation

   • Safety and Effectiveness: Detailed evaluation of the device’s safety and effectiveness based on the technical documentation and performance data provided.
   • Additional Information: Roszdravnadzor may request additional information or clarification on specific aspects of the device or documentation.

3. Testing and Inspection

   • Testing: If necessary, the device may undergo additional testing to verify its compliance with safety and performance standards.
   • Facility Inspection: An inspection of the manufacturing facility may be conducted to ensure that it adheres to quality management and production standards.

4. Consultation with Experts

   • Expert Review: In some cases, Roszdravnadzor may consult with external experts or technical committees to assess the device.

5. Final Decision

   • Approval or Rejection: Based on the review and evaluation, Roszdravnadzor decides whether to approve or reject the certification application.
   • Certification Issuance: If approved, the RZN certification is issued. If not approved, feedback is provided, and the applicant may need to address issues or resubmit the application.

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