To apply for Class I medical device registration with the Russian Ministry of Health (RZN, or Roszdravnadzor), you need to follow several key steps. Here's an outline of the process:

1. Prepare Required Documentation

You will need to gather several documents for the registration process:

• Application form for medical device registration in Russia.
• Certificate of Free Sale (CFS) or equivalent document confirming that the device is legally sold in the country of origin.
• Product Description: Detailed technical specifications and intended use of the medical device.
• Instructions for Use (User Manual).
• Manufacturing Information: Details about the manufacturer, including the quality management system (e.g., ISO 13485 certification, if applicable).
• Risk Management File: A document assessing the potential risks of the device.
• Labeling Information: Packaging and labeling details, including Russian language labeling.
• Clinical or Performance Data (if applicable).

For Class I devices, the regulatory requirements are typically less stringent, and you might not need extensive clinical trials or performance studies, but the documentation still needs to be thorough.

2. Submit the Application

Submit the completed application along with all required documents to Roszdravnadzor. This can be done through their online portal or directly to their office. Ensure that all documents are translated into Russian if necessary.

3. Review by Roszdravnadzor

Once submitted, Roszdravnadzor will review the application and documentation. For Class I devices, the process is generally quicker compared to higher-risk devices, as the regulatory burden is lighter.

4. Verification and Decision

Roszdravnadzor will verify the compliance of the device with the relevant technical regulations and safety standards. They may request additional information or clarifications during the process.

5. Issuance of Registration Certificate

If everything is in order, Roszdravnadzor will issue a registration certificate for the medical device, allowing it to be marketed and sold in Russia. This registration is valid for a period of up to 5 years, after which it can be renewed.

6. Post-Registration Requirements

After registration, the manufacturer must ensure that the device continues to meet Russian safety and quality standards. Any significant changes in the product, packaging, or manufacturing process may require re-registration.

Key Notes:

• Class I devices are typically low-risk products, and they are subject to less regulatory scrutiny compared to higher-risk categories (e.g., Class II or Class III devices).
• The application process for Class I medical devices is generally straightforward, but it's essential to comply with the required documentation and regulatory standards.
• If you are not familiar with Russian medical device regulations, it might be helpful to consult with a local regulatory expert or legal advisor to ensure compliance.

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