To apply for Class 2A medical device registration in Russia with Roszdravnadzor (RZN), several requirements must be met. These requirements are designed to ensure that the device is safe, effective, and compliant with Russian regulations before it is marketed and sold in the country.

Here is a comprehensive list of the requirements for applying for Class 2A medical device registration in Russia:

1. Classification of the Device

Before applying, confirm that your device qualifies as a Class 2A medical device under Russian regulations. Class 2A devices are typically medium-risk devices, such as diagnostic tools, therapeutic equipment, or devices that make limited contact with the human body. The classification will determine the documentation and processes required for registration.

2. Appointment of a Local Representative (If Applicable)

If the manufacturer is based outside of Russia, the manufacturer must appoint a local representative (a legal entity registered in Russia) to act as the liaison between the manufacturer and Roszdravnadzor. This representative will submit the application, handle communication with the authorities, and manage post-market surveillance activities in Russia.

• Legal entity: The local representative must be a Russian-based legal entity (e.g., a company or an authorized distributor) with an official contract signed with the manufacturer.
• Power of Attorney: The manufacturer must provide a notarized power of attorney to authorize the local representative to handle the registration process.

3. Required Documentation

To complete the registration application, several documents are required. These documents must be prepared in accordance with Russian medical device regulations and standards:

a. Registration Application Form

• A completed application form for registering the medical device with Roszdravnadzor. The form can be obtained from the Roszdravnadzor website or portal.

b. Manufacturer Documentation

• Certificate of Incorporation or other documents proving the manufacturer’s legal status and compliance with national laws in the country of origin.
• Notarized Certificate of Free Sale from the country of origin, indicating that the device is legally sold in the country of origin or other markets (such as the EU or the U.S.).

c. Technical Documentation (Technical File)

The technical documentation must include detailed information on the device, its design, manufacturing process, safety, and performance data. The file should include:

• Device Description: Detailed information about the device's function, intended use, and design.
• Manufacturing Process: Description of how the device is manufactured and quality controls implemented during production.
• Materials and Components: Information on the materials used in the device, particularly for devices in contact with the body (e.g., biocompatibility data).
• Risk Analysis: A risk management file demonstrating compliance with ISO 14971 or equivalent standards for identifying and mitigating risks associated with the device.
• Labeling: Samples of the device labeling (including the instructions for use) in Russian, as well as packaging details.
• Clinical Data: If applicable, clinical data or evidence demonstrating the safety and performance of the device (may not be required for all Class 2A devices, but is necessary for certain higher-risk devices).

d. Quality Management System (QMS) Certification

• ISO 13485 Certification: A certificate that demonstrates the manufacturer’s compliance with international Quality Management System (QMS) standards for medical devices.
  • If the manufacturer is located outside of Russia, this certificate should be issued by a recognized certification body in the manufacturer’s country of origin.

e. Declaration of Conformity

• If applicable, the manufacturer must provide a Declaration of Conformity to demonstrate that the device meets Russian national standards or international standards recognized by Roszdravnadzor.

f. Biocompatibility and Safety Data (if applicable)

• For devices that make contact with the human body (e.g., implants, diagnostic equipment), a biocompatibility report or toxicity report may be required to demonstrate the device’s safety.

g. Product Samples (if requested)

• Roszdravnadzor may request samples of the medical device for inspection or testing to verify that the product matches the specifications outlined in the registration dossier.

4. Submission of the Application

Once all the required documentation is prepared, the application must be submitted to Roszdravnadzor.

• Online submission: Applications can typically be submitted online via Roszdravnadzor’s official portal or through a representative.
• Paper submission: In some cases, paper submissions may still be accepted, though the online method is preferred.
• Fees: The application requires the payment of registration fees, which vary depending on the device’s classification and complexity. Fees are usually paid upon submission and can be checked on the Roszdravnadzor website.

5. Roszdravnadzor’s Review and Evaluation

After submission, Roszdravnadzor will evaluate the application. The review process typically includes the following:

1. Document Review:

   • Roszdravnadzor will examine all submitted documents, including the technical documentation, clinical data, QMS certificate, and labeling.

2. Inspection (If Applicable):

   • If the manufacturer is foreign, Roszdravnadzor may require an inspection of the manufacturing facility to ensure compliance with regulatory requirements. This may include a visit by a Russian inspection body to verify production processes and quality management systems.

3. Additional Documentation:

   • If Roszdravnadzor identifies any issues or requires further clarification, they will request additional information or documents.

4. Approval:

   • If all requirements are met, Roszdravnadzor will approve the device for sale in Russia and issue a registration certificate. The certificate is necessary for commercializing the device in the Russian market.

6. Receiving the Registration Certificate

Once the application is successfully processed and approved, the manufacturer or local representative will receive the registration certificate from Roszdravnadzor. The certificate is required to legally market and sell the device in Russia.

• Validity: The certificate is typically valid for 5 years and must be renewed before expiration.
• Russian Product Codes: The certificate will include the product codes for the device, which are required for marketing, distribution, and sales.

7. Post-Market Surveillance

After registration, the manufacturer and local representative are required to comply with post-market surveillance obligations, which include:

• Monitoring the safety and performance of the device.
• Reporting any adverse events or complaints associated with the device to Roszdravnadzor.
• Handling product recalls (if necessary) in the event of safety or quality issues.

Additional Considerations

• Russian Language: All submitted documents (e.g., instructions for use, labeling, and technical documentation) must be provided in Russian. The device label and instructions must be clear, accurate, and compliant with Russian language requirements.
• Clinical Trials: Clinical data may be required for some Class 2A devices if they are innovative, involve new technologies, or have specific risks.
• Regulatory Updates: Stay up-to-date with any changes to Russian medical device regulations to ensure compliance.

Timeline and Fees

• Timeline: The registration process usually takes 6 to 12 months, depending on the complexity of the device and the completeness of the documentation.
• Fees: Registration fees vary by device type and risk classification. The specific fee schedule is available on Roszdravnadzor's website.

By fulfilling these requirements and providing accurate documentation, manufacturers can successfully apply for Class 2A medical device registration in Russia.

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