To apply for the registration of a 2A class medical device in Russia with the Federal Service for Surveillance in Healthcare (Roszdravnadzor, or RZN), you'll need to follow a series of steps. Here is an outline of the process:

1. Determine the Classification of the Device

• Class 2A medical devices in Russia are typically medium-risk devices, and they require registration with Roszdravnadzor.
• Ensure that the device meets the criteria for a Class 2A device as defined by the Russian regulations.

2. Prepare Technical Documentation

You will need to prepare several documents, including:

• Technical File: This includes detailed information on the device's design, manufacturing process, performance, and safety.
• Clinical Data: Depending on the type of device, you may need to provide clinical evidence showing the device's safety and effectiveness.
• Quality Management System (QMS) Certificate: If applicable, a QMS certificate (e.g., ISO 13485) from a recognized body may be required to prove that the manufacturer adheres to quality standards.
• Risk Analysis: Conduct a risk analysis in accordance with ISO 14971 to demonstrate that risks associated with the device have been identified and mitigated.

3. Designate a Local Representative (if applicable)

If the manufacturer is based outside Russia, a local representative in Russia must be appointed. This entity will act as the liaison between the manufacturer and Roszdravnadzor for all matters related to registration and post-market surveillance.

4. Prepare the Registration Dossier

The registration dossier for a Class 2A device should include the following:

• Application form for registration
• Manufacturer’s certificate (if the manufacturer is foreign, this must be notarized)
• Product labeling and instructions for use in Russian
• Evidence of conformity with Russian technical standards (if applicable)
• Clinical trial data (if applicable)
• Certificate of free sale from the country of origin (if applicable)

5. Submit the Application

Submit the registration dossier to Roszdravnadzor. This is typically done via their official online portal or in paper form, depending on the specifics of the submission process.

Submission can include:

• Application form
• Copies of all necessary documents (translated into Russian, where applicable)
• Manufacturer’s declaration of conformity (or a certificate if required)
• Product samples (if requested by Roszdravnadzor)
• Proof of payment for the registration fee

6. Review and Approval by Roszdravnadzor

Roszdravnadzor will review the submission, which typically takes several months. The review process includes:

• Technical review of the submitted documents
• Inspection of the manufacturing facility (if necessary)
• Evaluation of clinical data (if applicable)

7. Receive Registration Certificate

If the review is successful, you will receive the registration certificate for the device, which is required for selling and distributing the device in Russia.

8. Post-market Surveillance

After registration, the device will be subject to post-market surveillance by Roszdravnadzor, which includes monitoring for adverse events, product recalls, and other issues.

Timeline and Fees

• The entire process can take anywhere from 6 to 12 months, depending on the complexity of the device and the completeness of the submission.
• Fees for the registration process vary depending on the type of device and its classification.

It is recommended to work with a regulatory consultant or legal representative familiar with Russian medical device regulations to navigate the process efficiently.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn