Obtaining RZN certification for Class 2b medical devices in Russia typically takes 6 to 12 months. The timeframe can vary based on several factors:

1. Preparation Phase

• Document Compilation: Preparing the necessary documentation can take several weeks to a few months. This includes translating documents into Russian, compiling technical files, and ensuring all quality management system (QMS) documentation is in place.

2. Application Submission

• Initial Processing: After submitting the application, Roszdravnadzor will conduct an initial review of the submitted documents. This initial review generally takes a few weeks.

3. Review and Evaluation

• Technical Evaluation: The in-depth technical evaluation of the device’s safety, efficacy, and compliance with Russian standards is a critical part of the process. This evaluation can take several months, depending on the complexity of the device and the completeness of the documentation.

• Additional Information Requests: If Roszdravnadzor requests additional information or clarifications, this can extend the processing time. The time required to respond to these requests and resubmit documents can affect the overall timeline.

4. Facility Inspection

• Inspection (if required): For certain devices, Roszdravnadzor may conduct an on-site inspection of the manufacturing facility to verify compliance with quality and safety standards. The scheduling and completion of this inspection can add to the processing time.

5. Certification Decision

• Final Decision: Once the review and evaluation are complete, Roszdravnadzor will make a decision on the certification. The issuance of the certification, following a positive decision, can take additional weeks.

Factors Affecting Timeline

• Completeness of Submission: Thorough and accurate documentation can expedite the process, while incomplete or incorrect submissions can lead to delays.
• Complexity of Device: More complex devices may require more detailed evaluations, potentially extending the review period.
• Response Time: How quickly and efficiently you respond to any additional information requests or queries from Roszdravnadzor can influence the overall duration.