Steps and Process for Class 2A Medical Device Registration in Russia with Roszdravnadzor (RZN)

Class 2A medical devices in Russia are classified as medium-risk devices, and their registration process with Roszdravnadzor (Russian Federal Service for Surveillance in Healthcare) is essential to market and distribute the device within the Russian Federation. Here are the key steps involved in the registration process for Class 2A medical devices:

Step 1: Determine Device Classification

Before starting the registration process, ensure that your device is indeed classified as a Class 2A medical device. Class 2A devices are typically medium-risk devices and can include equipment like diagnostic tools, certain types of implants, or devices that come into contact with the body for short periods.

• Devices are classified according to the Russian Classification System for Medical Devices, which is aligned with international standards like the GHTF (Global Harmonization Task Force).
• Class 2A devices pose a moderate risk and require standard registration procedures with Roszdravnadzor.

Step 2: Appoint a Local Representative (If Applicable)

If the manufacturer is based outside Russia, the manufacturer must appoint a local representative in Russia. This representative must be a legal entity registered in Russia, and they will serve as the point of contact for all communication with Roszdravnadzor.

• The local representative is responsible for submitting the application, providing post-market surveillance, and handling regulatory inspections.
• The manufacturer must formally designate the local representative by signing an official power of attorney.

Step 3: Gather Required Documentation

Prepare a comprehensive set of documents required for submission to Roszdravnadzor. These documents will vary depending on the device type, but generally, they include:

1. Application Form:

   • A completed registration application form, which can be downloaded from Roszdravnadzor's official website.

2. Manufacturer’s Legal Documents:

   • Manufacturer’s registration documents, such as a copy of the certificate of incorporation and proof of manufacturing capacity.
   • A Notarized Certificate of Free Sale from the manufacturer’s home country, indicating that the device is legally sold in the country of origin.

3. Technical File:

   • Detailed technical documentation that describes the device's design, materials, intended use, functionality, and performance. This file should include:
     • Device description and specifications
     • Design drawings and material data
     • Manufacturing process details
     • Risk analysis (according to ISO 14971 or equivalent standard)
     • Labeling and packaging information, including the Russian-language version of the instructions for use

4. Clinical Data (if applicable):

   • Clinical trial data or post-market clinical experience to demonstrate the safety and performance of the device. This is typically required for higher-risk devices, but it may be necessary depending on the device's nature and intended use.

5. Quality Management System (QMS) Certificate:

   • An ISO 13485 certificate (or an equivalent standard) demonstrating that the manufacturer has an effective quality management system in place. This is particularly important for foreign manufacturers.

6. Declaration of Conformity (if applicable):

   • A document confirming that the device complies with Russian technical standards or international harmonized standards recognized by Roszdravnadzor.

7. Other Documents:

   • A biocompatibility report (if applicable) for devices that come into contact with the body, such as implants or diagnostic tools.
   • Samples of the device may be requested by Roszdravnadzor for testing or inspection.

Step 4: Submit the Registration Application to Roszdravnadzor

Once all documents are prepared, submit the application and accompanying documentation to Roszdravnadzor for review. The submission can typically be done online through Roszdravnadzor’s portal or in person, depending on the current process.

• If the manufacturer is foreign, the local representative in Russia must submit the application on the manufacturer’s behalf.
• Fee Payment: Pay the relevant registration fees, which vary based on the device classification and type. The fees are usually paid upon submission of the application.

Step 5: Review and Evaluation by Roszdravnadzor

Once the application is submitted, Roszdravnadzor will initiate the review process, which typically includes the following:

1. Document Review:

   • Roszdravnadzor will review the technical documentation, clinical data (if applicable), and quality management system certificate to ensure compliance with Russian regulations.

2. Manufacturing Facility Inspection (If Required):

   • For foreign manufacturers, Roszdravnadzor may request an inspection of the manufacturing facility to ensure that it adheres to regulatory requirements. This inspection will be conducted by a Russian inspection body accredited by Roszdravnadzor.

3. Additional Information:

   • If Roszdravnadzor finds any discrepancies or needs more information, they will issue a request for additional documentation. The applicant must respond promptly.

4. Approval:

   • If the device passes the review, Roszdravnadzor will issue the registration certificate for the medical device. This certificate is required to legally sell the device in Russia.

Step 6: Receive Registration Certificate

If the device meets all the necessary requirements, Roszdravnadzor will issue a registration certificate. This certificate is the official document that allows the device to be marketed and distributed in Russia.

• Validity: The registration certificate is typically valid for 5 years, after which it must be renewed.
• Product Codes: The certificate will include the Russian product codes for your medical device, which will be needed for future marketing and sales activities.

Step 7: Post-Market Surveillance and Compliance

After obtaining the registration certificate, the manufacturer or the local representative must ensure that the device complies with post-market surveillance requirements, including:

1. Reporting Adverse Events: Manufacturers are required to report any adverse events or safety issues related to the device.
2. Product Recalls (If Necessary): If safety concerns arise, Roszdravnadzor may require the device to be recalled from the market.
3. Periodic Safety Updates: Manufacturers may be required to submit periodic safety reports to Roszdravnadzor.

Additional Considerations:

• Clinical Trials: While clinical trials may not be required for all Class 2A devices, they may be necessary for some products, particularly those with new technologies or significant changes from previously marketed devices.
• Russian Language: All documentation (labels, instructions for use, and technical documentation) must be provided in the Russian language.

Timeline and Costs

• Timeline: The registration process can take anywhere from 6 to 12 months, depending on the complexity of the device and the completeness of the submission.
• Costs: The registration fees vary based on the device’s classification and complexity. Roszdravnadzor provides a fee schedule that should be consulted for up-to-date pricing.

By following these steps and preparing the necessary documentation, manufacturers can successfully navigate the Class 2A medical device registration process with Roszdravnadzor and enter the Russian market.

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