Applying for RZN (Russian Ministry of Health) certification for Class 2b medical devices in Russia involves several steps. Here's a detailed guide:

1. Understand the Classification and Requirements

Class 2b Devices: These are considered medium-risk devices. The requirements for Class 2b devices are more stringent compared to Class 1 and 2a devices. Ensure your device fits the classification before proceeding.

2. Prepare Necessary Documentation

You'll need to gather and prepare various documents for the application process:

• Technical Documentation: This includes device specifications, design and manufacturing details, and user manuals.
• Clinical Evidence: Clinical evaluation or trial data demonstrating the device's safety and efficacy.
• Quality Management System (QMS) Documentation: Evidence that your manufacturing processes comply with international standards (e.g., ISO 13485).
• Labeling and Instructions for Use: Russian language labeling and instructions are typically required.
• Declaration of Conformity: If the device is certified in other countries, provide proof of compliance.

3. Engage a Notified Body or Authorized Representative

Since you might not be able to handle all aspects of the application directly, consider engaging with a local Notified Body or Authorized Representative (AR) in Russia. They can guide you through the regulatory requirements and handle the submission process.

4. Submit the Application

Submit the completed application along with all required documentation to the Federal Service for Surveillance in Healthcare (Roszdravnadzor). The submission can often be done electronically, but it is crucial to check current procedures with Roszdravnadzor.

5. Undergo a Technical Evaluation

The technical evaluation involves a review of the submitted documentation, including the technical file, clinical data, and QMS. Roszdravnadzor may request additional information or modifications.

6. Conduct a Factory Inspection

For Class 2b devices, Roszdravnadzor may require an inspection of the manufacturing facility to ensure compliance with regulatory standards. This inspection assesses the QMS and production processes.

7. Receive Certification

Once the evaluation and inspection are completed, and if everything is in order, you will receive the RZN certificate. This certification is necessary for marketing and selling the device in Russia.

8. Maintain Compliance

After obtaining certification, ensure continuous compliance with Russian regulations. This includes adhering to post-market surveillance requirements, updating documentation as necessary, and renewing the certification as required.

Additional Considerations

• Language Requirements: Ensure that all documentation is available in Russian, including labels and instructions for use.
• Regulatory Changes: Stay informed about any changes in Russian regulations that could affect your certification status.
• Local Representation: Having a local representative or distributor in Russia can facilitate communication with regulatory authorities and assist in compliance.

Resources and Contacts:

• Roszdravnadzor: The Federal Service for Surveillance in Healthcare is the primary regulatory body overseeing medical device certification in Russia. Their website provides guidance and contact information.
• Notified Bodies: Engage with a Notified Body or regulatory consultant familiar with Russian regulations for assistance.

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