To apply for Class 2A medical device registration in Russia, the process is managed by the Federal Service for Surveillance in Healthcare (commonly known as Roszdravnadzor). Below is a step-by-step guide on how to apply, including where to apply and the necessary details.

Where to Apply for Class 2A Medical Device Registration in Russia?

You will submit your application to Roszdravnadzor, the Russian regulatory authority responsible for medical device registration and monitoring.

• Online Portal: The primary platform for submitting applications is the Unified State Register of Medical Devices (available on the Roszdravnadzor website).
• Mail Submission: In some cases (such as for specific devices or where online submission is not possible), you may need to submit documents by mail to Roszdravnadzor’s physical address.

Roszdravnadzor's Contact Information:

• Official Website: https://www.roszdravnadzor.ru
• Mailing Address:
  Roszdravnadzor
  11, 4th Veshnyakovsky Lane,
  Moscow, 109017,
  Russia

Steps for Applying for Class 2A Medical Device Registration in Russia

Step 1: Classify Your Medical Device

• Verify Classification: Ensure your device qualifies as a Class 2A medical device according to Russian medical device regulations. Class 2A devices are typically low- to moderate-risk medical devices, such as diagnostic devices or some therapeutic equipment.
• If you're unsure of the classification, refer to the Russian Classification Rules for Medical Devices, which are aligned with international classifications like those of the EU (MDR) or FDA.

Step 2: Appoint a Local Representative (If Foreign Manufacturer)

• If your company is based outside of Russia, you must appoint a local representative in Russia to handle the registration process.
• The local representative can be a Russian legal entity (e.g., a distributor or regulatory affairs consultant). This representative will be responsible for submitting the application, managing the registration, and acting as a liaison with Roszdravnadzor.
• A Power of Attorney (POA) from the manufacturer must be provided to the local representative.

Step 3: Prepare Required Documentation

Here’s a checklist of documents that will need to be submitted for Class 2A medical device registration:

1. Registration Application Form

   • Complete the application form available on the Roszdravnadzor website or submit the physical form by mail.

2. Manufacturer’s Legal Documents

   • Certificate of Incorporation of the manufacturer.
   • Power of Attorney (for foreign manufacturers appointing a local representative).
   • Certificate of Free Sale (CFS) showing that the device is freely marketed and sold in the country of manufacture (or another major market like the EU or U.S.).

3. ISO 13485 Certification

   • Quality Management System (QMS) Certificate demonstrating that the manufacturer complies with international standards for medical device manufacturing, such as ISO 13485.

4. Technical Documentation (Technical File)

   • Device Description: Full details about the device, including its intended use, functionality, and design.
   • Risk Management Documentation: A risk analysis document prepared in accordance with ISO 14971.
   • Clinical Data (If applicable): Data supporting the device's safety and efficacy, which may include clinical trial reports or performance data.
   • Biocompatibility and Safety Testing Reports: Results from testing the materials and safety of the device.
   • Performance Data: Any performance or reliability testing that supports the device’s effectiveness.

5. Declaration of Conformity

   • A declaration signed by the manufacturer confirming that the device complies with Russian and international regulations. If the device has a CE mark, this is usually accepted.

6. Packaging and Labeling

   • Instructions for Use (IFU) and labeling in Russian.
   • Ensure compliance with Russian labeling requirements, including mandatory symbols and language.

7. Product Samples (if applicable)

   • If requested by Roszdravnadzor, provide product samples for testing or evaluation.

Step 4: Submit the Application

There are two primary ways to submit your application for medical device registration in Russia:

1. Online Submission

   • Visit the Roszdravnadzor Portal (Unified State Register of Medical Devices) to complete the registration process online.
   • Create an account and fill out the registration application form, upload all required documents, and pay the registration fee via the portal.

2. Mail Submission

   • If online submission is not possible, you can send the completed registration application form and all required documents to Roszdravnadzor’s official address by mail.
   • Ensure that all documents are translated into Russian and notarized (if necessary).

Step 5: Pay the Registration Fee

• The registration fee for Class 2A medical devices in Russia ranges from RUB 100,000 to RUB 300,000 (approximately USD 1,000 to USD 3,000), depending on the complexity and classification of the device.
• Payment is required at the time of submission. If you submit the application online, you can pay via the Roszdravnadzor portal. If submitting by mail, the payment instructions will be provided by Roszdravnadzor.

Step 6: Roszdravnadzor Review and Evaluation

• Review Time: The review process typically takes 6 to 12 months but can vary depending on the complexity of the device and the completeness of the application.
• During this period, Roszdravnadzor may request additional information or clarifications. Ensure prompt responses to avoid delays.
• If necessary, Roszdravnadzor may require an inspection of the manufacturing facility, especially for foreign manufacturers.

Step 7: Receive the Registration Certificate

• If the application is approved, Roszdravnadzor will issue a Registration Certificate, allowing the device to be marketed and sold in Russia.
• The registration certificate is usually valid for 5 years.
• After receiving the certificate, the device can be marketed and sold in Russia, provided the manufacturer complies with post-market surveillance and reporting requirements.

Important Considerations

1. Translation Requirements

   • All documents must be submitted in Russian, including labeling, instructions for use, and any clinical or technical documentation. Professional translation services may be necessary to ensure compliance.

2. Local Representative

   • Foreign manufacturers must have a local representative in Russia who will handle the registration process and communication with Roszdravnadzor. This representative must be a Russian legal entity.

3. Post-Market Surveillance

   • Once registered, the manufacturer is responsible for ongoing post-market surveillance of the device in Russia. Any adverse events or product recalls must be reported to Roszdravnadzor.

4. Device Classification

   • Ensure that the device is correctly classified as Class 2A according to the Russian medical device regulations. If there is any doubt, consult the Russian Classification Rules for Medical Devices or seek advice from regulatory professionals.

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