To obtain RZN certification for Class 2a medical devices in Russia, follow these steps:

1. Prepare Documentation:

   • Device Information: Technical description, intended use, and design details.
   • Clinical Data: Evidence of safety and effectiveness, including clinical trials if applicable.
   • Manufacturing Information: Details about the manufacturing process and quality management system.

   • Compliance Documentation: Proof of compliance with international standards and regulations.

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2. Select a Certification Body:

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   • Choose a Certification Body accredited by Roszdravnadzor (Federal Service for Surveillance in

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   • Healthcare) that is authorized to issue RZN certificates.

3. Submit Application:

   • Complete and submit the application form along with all required documentation to the selected Certification Body.

4. Device Testing and Evaluation:

   • The Certification Body may require testing of the device to ensure it meets Russian standards. This might include laboratory testing and evaluation of clinical performance.

5. Review Process:

   • The Certification Body reviews the submitted documents and test results. They may request additional information or modifications.

6. Certification Decision:

   • If the application meets all requirements, the Certification Body issues the RZN certification. This may include a certificate of conformity or registration.

7. Post-Certification Requirements:

   • Ensure ongoing compliance with Russian regulations, including possible periodic audits or updates.

8. Market Authorization:

   • Once certified, you can legally market and sell your Class 2a medical device in Russia.

Additional Tips:

• Work with a local regulatory consultant to navigate the certification process efficiently.

• Keep abreast of any regulatory changes that might affect the certification process.

Contact Us：

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