To apply for Class I medical device registration with Roszdravnadzor (RZN) in Russia, certain conditions must be met to ensure that the device complies with Russian regulatory requirements. These conditions are related to the device’s classification, documentation, compliance with standards, and the responsibilities of the manufacturer or authorized representative.

Conditions for Applying for Class I Medical Device Registration with Roszdravnadzor (RZN)

1. Device Classification as Class I

• The device must be correctly classified as a Class I medical device according to Russian regulations or the Eurasian Economic Union (EAEU) technical regulations.
• Class I devices are considered low-risk products that typically do not require clinical testing or detailed performance data. However, they must still comply with general safety and quality requirements.

2. Compliance with Russian and EAEU Regulations

• The medical device must meet the Russian Federal Law on the Circulation of Medicines (No. 61-FZ) and EAEU Technical Regulation No. 36 (or EAEU TR 037/2016), which defines the requirements for medical devices in the member countries (Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan).
• The device should also comply with Russian standards (GOST), which are technical norms for product quality and safety.

3. Manufacturing Standards and Quality Management

• The manufacturer must ensure that the device is produced in compliance with internationally recognized Good Manufacturing Practices (GMP) or other appropriate quality management standards (such as ISO 13485 for medical devices).
• ISO 13485 certification (or equivalent) is recommended for manufacturers to demonstrate their commitment to quality in the design, development, and manufacturing of medical devices.

4. Authorized Representative (For Foreign Manufacturers)

• If the manufacturer is located outside Russia, they must appoint a local authorized representative in Russia to handle the registration process on their behalf. The representative will submit the registration application, track the process, and receive the registration certificate on behalf of the manufacturer.
• A signed agreement between the manufacturer and the authorized representative must be submitted along with the application.

5. Legal Status of the Manufacturer

• The manufacturer must be legally registered and authorized to produce and sell medical devices in their country of origin. A Certificate of Free Sale (CFS) issued by the regulatory authority in the country of origin must be provided to demonstrate that the device is freely marketed and legally sold there.

6. Device Safety and Efficacy

• Even though Class I devices are low-risk, the manufacturer must provide adequate documentation to show that the device is safe for its intended use. This includes:
  • Product description (including specifications and intended use).
  • Risk management documentation to demonstrate that any risks associated with the device are minimized.
  • Instructions for Use (IFU) in Russian that clearly state how the device is to be used, maintained, and disposed of.
  • Labeling information in Russian, which must include the device’s name, manufacturer, and safety warnings.

7. Device Compliance with Labeling Requirements

• All labeling must comply with Russian regulations and be provided in Russian. This includes:
  • Device name and model.
  • Name and contact details of the manufacturer or authorized representative.
  • Instructions for use.
  • Expiry date, storage conditions, and other relevant details.

8. Translation of Documents into Russian

• All documentation submitted for the registration process must be translated into Russian. This includes:
  • Product description, instructions for use, labels, and Certificates of Free Sale.
  • Translations must be done by a certified translator and, in some cases, notarized.

9. Completeness of the Application

• The application must be complete, with all necessary documents properly prepared and uploaded or submitted to Roszdravnadzor. Incomplete applications or missing documents may lead to delays or rejection of the registration.

10. Payment of Registration Fees

• The registration fee must be paid as required by Roszdravnadzor. The fee amount for Class I medical devices is typically lower than for higher-risk devices, but it must still be settled before the registration process can proceed.

11. Post-Market Surveillance Responsibilities

• Even for Class I devices, manufacturers are obligated to monitor the device after it enters the market. This includes:
  • Reporting adverse events or problems with the device to Roszdravnadzor.
  • Ensuring that the device remains compliant with regulatory standards throughout its life cycle.
  • Conducting any necessary recalls or corrective actions if safety issues arise.

Key Considerations

1. Use of the Roszdravnadzor Portal

   • Online submission of the registration application is mandatory. The Roszdravnadzor portal facilitates the submission of the application and payment of the registration fee. You will need to create an account and submit all required documents electronically.

2. Duration and Fees

   • The registration process for Class I devices is generally faster and more straightforward compared to higher-risk classes, typically taking around 2 to 3 months.
   • The registration fee is generally lower for Class I devices compared to other classes.

3. Maintenance of Registration

   • Once a Class I medical device is registered, the manufacturer must ensure it continues to meet all safety and quality standards. Roszdravnadzor may require periodic reports or updates regarding the device's performance on the market.

4. Changes to the Device or Documentation

   • If there are any significant changes to the device, its labeling, or its manufacturing process, you may need to update your registration. Any modifications must be reported to Roszdravnadzor.

Conclusion

In summary, the conditions for applying for Class I medical device registration with Roszdravnadzor (RZN) in Russia include ensuring the device meets low-risk classification, complies with Russian and EAEU standards, has the necessary documentation (e.g., Certificate of Free Sale, product description, instructions for use in Russian), and includes proper labeling. If the manufacturer is outside of Russia, an authorized representative in Russia must be appointed. Once all conditions are met, you can submit the application through the Roszdravnadzor portal and track the process until you receive the registration certificate.