The processing time for Class I medical device registration with Roszdravnadzor (RZN) in Russia is generally shorter compared to higher-risk medical devices. On average, the registration process for Class I medical devices takes approximately 2 to 3 months from the submission of a complete application.

Key Factors Affecting Processing Time:

1. Completeness of the Application

   • If your application is complete and all required documents are submitted correctly (including Russian translations), the process will be faster.
   • Incomplete or incorrectly filed applications may delay the process, as Roszdravnadzor will need additional time to request and review missing information.

2. Review and Evaluation

   • Roszdravnadzor typically performs a review of the submitted documents, including checking for compliance with Russian medical device regulations and EAEU technical regulations.
   • The review process is usually less complicated for Class I devices, as they are considered low-risk products. However, if the device is new or involves a novel technology, Roszdravnadzor may require additional clarifications, which could add to the timeline.

3. Communication with Roszdravnadzor

   • During the processing time, Roszdravnadzor may request additional documentation or clarification on specific aspects of your submission. Timely responses to these requests can help avoid delays.
   • If an authorized representative is handling the registration for a foreign manufacturer, it may also take additional time to coordinate between the representative and Roszdravnadzor.

4. Registration Fee Payment

   • The payment of the registration fee is usually processed quickly, but it must be completed before the application is considered. Delays in payment could also impact the timeline.

Possible Delays:

• Incomplete Documentation: If any required documents (e.g., Certificate of Free Sale, product description, risk management documents, etc.) are missing or incorrectly translated, the process may take longer.
• Request for Additional Information: Roszdravnadzor may ask for more data or clarification on the device's safety, efficacy, or manufacturing process.
• High Volume of Applications: Processing times could be longer if there is a backlog of applications at Roszdravnadzor.

Conclusion:

• The typical processing time for a Class I medical device registration with Roszdravnadzor is 2 to 3 months if all documentation is in order and no significant issues arise during the review process. However, timely submission of complete and accurate documentation can help avoid delays and ensure a smooth and efficient registration process.