The process for RZN certification of Class I medical devices involves the following steps:

1. Preparation:

   • Gather Documentation: Compile all required technical documents, including product specifications, quality management system details, and test results.
   • Translation: Ensure that documents are translated into Russian if necessary.

2. Application:

   • Complete Application Form: Obtain and fill out the application form from Roszdravnadzor.
   • Submit Application: Submit the completed form and all supporting documents to Roszdravnadzor either electronically or in person.

3. Review:

   • Document Review: Roszdravnadzor reviews your application and documentation. They may request additional information or clarification.
   • Inspection (if applicable): Roszdravnadzor may conduct an inspection or audit of your facilities if required.

4. Certification:

   • Receive Certification: If your application meets all requirements, Roszdravnadzor will issue the certification for your Class I medical device.

5. Post-Certification:

   • Maintain Compliance: Adhere to ongoing regulatory requirements and standards.
   • Post-Market Surveillance: Monitor the device’s performance in the market and report any issues as needed.

Following these steps ensures a thorough and compliant certification process for your medical device.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn