Class 2A Medical Device Registration in Russia refers to the registration process for medium-risk medical devices in accordance with Russian regulations. In Russia, medical devices are classified into four risk classes:

• Class 1: Low-risk devices
• Class 2A: Medium-risk devices
• Class 2B: High-medium-risk devices
• Class 3: High-risk devices

Class 2A devices typically have a moderate risk to the patient and/or user and require registration with Roszdravnadzor (RZN), the Russian Federal Service for Surveillance in Healthcare. This process involves ensuring that the device meets the necessary safety, effectiveness, and quality standards before it is allowed to be marketed in Russia.

2A Class Medical Device Registration Process in Russia

The registration process for Class 2A medical devices in Russia is outlined below. It involves several steps, including the preparation of technical documentation, the submission of an application, and a regulatory review by Roszdravnadzor.

Steps to Apply for Class 2A Medical Device Registration with RZN

1. Device Classification

• Ensure that your medical device qualifies as Class 2A according to Russian regulations. Class 2A devices are those that pose a moderate risk to patients or users. The classification is determined by the device's intended use, characteristics, and potential risk factors.

2. Prepare the Required Documentation

For the application process, you will need to gather a comprehensive set of documents. This includes:

• Application Form: Complete the registration application form, which can be obtained from the Roszdravnadzor website.
• Manufacturer's Documentation: Include the manufacturer's details and information, such as their legal status and manufacturing capabilities.
• Technical File: This file includes technical documentation that describes the design, materials, functionality, and intended use of the device. It may also include:
  • Design and manufacturing process details
  • Risk analysis (based on ISO 14971 or equivalent standards)
  • Safety and performance data
• Clinical Data: If required, provide clinical trial data or evidence of the device's safety and performance.
• Product Labeling: Include the device's labels and instructions for use in Russian.
• Quality Management System (QMS) Certification: A valid ISO 13485 certificate (or equivalent) may be required to demonstrate that the manufacturer operates a quality management system.
• Certificate of Free Sale: A certificate issued by the manufacturer’s country of origin that confirms the device is approved for sale in the manufacturer’s home market (if applicable).
• Conformity Assessment: If applicable, evidence that the device meets Russian technical standards or international standards recognized by Roszdravnadzor.

3. Designate a Local Representative (if applicable)

• If the manufacturer is based outside Russia, a local representative (Russian legal entity) must be designated to serve as the liaison with Roszdravnadzor. The local representative will handle the registration submission, communicate with regulatory authorities, and act as a point of contact for post-market surveillance.

4. Submit the Registration Application

The registration application, along with the required documentation, is submitted to Roszdravnadzor. You can submit the application online via the Roszdravnadzor portal or through a paper submission, depending on the current process.

Documents typically required for submission:

• Completed application form
• Notarized copies of the manufacturer’s legal documents
• Technical documentation (including a risk analysis, product description, and clinical data)
• Product samples (if requested by Roszdravnadzor)
• Proof of payment of registration fees

5. Review and Inspection by Roszdravnadzor

• Roszdravnadzor will review the submitted documents to ensure that the device complies with Russian regulations. This review may include an examination of clinical data, safety documentation, and risk analysis.
• Inspection: In some cases, Roszdravnadzor may request an on-site inspection of the manufacturing facility, particularly if it is located outside Russia.
• Additional Documentation: If Roszdravnadzor requests additional information, you will need to provide it before they can proceed with the review.

6. Receiving the Registration Certificate

• If Roszdravnadzor approves the device for sale in Russia, they will issue a registration certificate for the device. This certificate is required for the marketing and distribution of the device within Russia.
• The registration certificate is typically valid for 5 years, after which it needs to be renewed.

7. Post-Market Surveillance

• Once the device is on the market, the manufacturer and local representative must comply with Russia's post-market surveillance requirements. This includes monitoring for adverse events, reporting complaints, and adhering to any necessary product recalls or safety measures.

Timeline for Registration

• The registration process typically takes 6 to 12 months depending on the complexity of the device and the completeness of the application.
• If the device undergoes a clinical trial or requires additional testing, the timeline may be longer.

Fees for Registration

• Registration fees for medical devices in Russia vary based on the type of device, its classification, and the services required. It is important to check the current fee schedule on Roszdravnadzor's website.

Tips for a Successful Registration:

• Ensure that all documents are translated into Russian (especially the instructions for use and product labeling).
• Work with a local regulatory consultant or legal representative who is familiar with Russian medical device regulations to help navigate the process efficiently.
• Stay up-to-date with any changes in Russian medical device laws or Roszdravnadzor’s registration procedures.

By following these steps and ensuring that all required documentation is properly prepared and submitted, you can successfully register your Class 2A medical device with Roszdravnadzor in Russia.

Contact Us：

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