To register a Class I medical device with Roszdravnadzor (RZN) in Russia, the device must meet certain regulatory requirements. Class I devices are considered low-risk, so the process is simpler compared to higher-risk devices, but still requires careful attention to compliance with Russian medical device regulations.

Here are the key requirements for registering a Class I medical device with Roszdravnadzor:

1. Application Form

• Completed application: You must submit an official registration application form for the medical device. This can be done via the RZN portal or in paper form, depending on the submission method.

2. Manufacturer Information

• Manufacturer details: Information about the manufacturer, including their name, location, and business registration.
• Quality Management System: Proof that the manufacturer operates under a quality management system (e.g., ISO 13485) or equivalent certification to ensure the device is consistently manufactured to meet safety and quality standards.

3. Certificate of Free Sale (CFS)

• CFS: A document from the country of origin (e.g., the USA or EU) stating that the device is legally marketed and available for sale there. This is necessary to demonstrate that the product is already authorized for use in the country of manufacture.
• Translation: The CFS must be translated into Russian.

4. Product Description

• Detailed product information: This should include technical specifications, intended use, description of the device, its components, and how it works.
• Risk assessment: A document assessing the potential risks of the device (although this is typically simpler for Class I devices compared to higher-risk devices).

5. Instructions for Use (IFU)

• IFU: A clear, detailed manual that provides instructions on how to use the device. The IFU must be in Russian and follow specific Russian regulatory guidelines for medical device labeling.

6. Labeling Information

• Product labeling: The labels on the medical device packaging must comply with Russian labeling requirements. Labels should include information such as the manufacturer's name, device name, intended use, and storage conditions, and all text must be in Russian.

7. Clinical and Performance Data (if applicable)

• Clinical data: Class I devices typically do not require clinical data unless specified by Roszdravnadzor. However, if the device is subject to special regulations, or if there is a higher level of risk involved, clinical or performance data may be required.

8. Compliance with Russian Technical Regulations

• Technical Regulations: Your device must comply with Russian technical regulations for medical devices. This includes compliance with the Federal Law on Technical Regulation and the Eurasian Economic Union (EAEU) regulations (if applicable).

9. Product Testing (if applicable)

• Depending on the device type, certain products may require testing by an accredited testing laboratory in Russia. However, for most Class I devices, this is generally not required unless there are specific concerns about safety or efficacy.

10. Proof of Payment for Registration Fees

• Registration fee: The application for registration comes with a fee, which varies depending on the device and the specifics of the application process. The fee should be paid as required by Roszdravnadzor.

11. Post-Market Surveillance and Reporting

• Post-market obligations: Once registered, manufacturers must comply with Russia's post-market surveillance requirements. This includes reporting adverse events, changes to the product, or any issues related to the device’s safety and efficacy.
• Updates or modifications: If the device undergoes significant changes (e.g., design, manufacturing process, labeling), the device may need to be re-registered.

12. Russian Representation

• Authorized Representative: If the manufacturer is located outside Russia, they must appoint an authorized representative in Russia who will act on their behalf to handle the registration process and liaise with Roszdravnadzor.

13. Validity of Registration

• Once the device is registered, the registration certificate is typically valid for 5 years. After that period, it must be renewed.

General Process Overview:

1. Prepare all required documentation as outlined above.
2. Submit the application and documentation to Roszdravnadzor, either electronically via their portal or in person.
3. Roszdravnadzor reviews the application, ensuring the device complies with Russian regulations.
4. If the documentation is complete and compliant, Roszdravnadzor issues a registration certificate allowing the device to be sold and marketed in Russia.
5. Post-registration compliance involves ongoing reporting and adherence to regulatory obligations.

Conclusion

The requirements for Class I medical device registration with Roszdravnadzor are focused on ensuring that low-risk devices meet safety and quality standards. The process is simpler than for higher-risk devices, but it still requires careful preparation of documentation and adherence to Russian regulations. If needed, it is advisable to consult a local regulatory expert to navigate the registration process smoothly.

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