To apply for Class I medical device registration with Roszdravnadzor (RZN) in Russia, you can follow the steps outlined below, including where and how to submit your application.

Steps for Applying for Class I Medical Device Registration with Roszdravnadzor

1. Prepare the Required Documents

Before you can submit your application, ensure you have all the necessary documentation ready. These documents typically include:

• Registration application form (completed through the Roszdravnadzor portal)
• Certificate of Free Sale (CFS) from the country of origin (translated into Russian)
• Product description (including intended use, technical specifications, classification details)
• Instructions for Use (IFU) in Russian
• Manufacturing information (such as ISO certifications and manufacturing process details)
• Risk management documentation
• Labeling information in Russian
• Authorized Representative Agreement (if applicable, for foreign manufacturers)

2. Register on the Roszdravnadzor Portal

To apply for registration online, you must first create an account on the official Roszdravnadzor portal.

• Portal for Registration: Roszdravnadzor Portal

Steps on the portal:

1. Create an account: Register your company on the portal by filling out your basic company information.
2. Submit the application: Complete the medical device registration form on the portal. This will require you to enter details about your device, its classification (Class I), and other required information.
3. Upload required documents: Upload all the necessary documents, including translations, product descriptions, and certificates.
4. Payment of fees: After submitting the form, you will be prompted to pay the registration fee via the portal.

3. Authorized Representative (for Foreign Manufacturers)

If your company is located outside Russia, you will need to appoint an authorized representative in Russia to handle the registration process on your behalf. The authorized representative is responsible for managing communications with Roszdravnadzor, submitting documents, and receiving the registration certificate.

• You will need to submit a signed agreement between your company and the authorized representative to show their responsibility in the process.

4. Submit the Application

• Once all documents are prepared and the registration form is completed, you can submit the application via the Roszdravnadzor portal. For foreign manufacturers, the authorized representative will handle the submission.

• Note: If you are submitting physical copies of documents, you can send them to the Roszdravnadzor office in Moscow. However, submitting through the online portal is the preferred method.

5. Review by Roszdravnadzor

After submission, Roszdravnadzor will review the application and documents. The review process for Class I medical devices is typically faster compared to higher-risk devices. The process usually takes around 2 to 3 months.

• During the review, Roszdravnadzor may request additional information or clarification, which could delay the process.

6. Receive Registration Certificate

Once the review is completed and the device is approved, Roszdravnadzor will issue a registration certificate for the medical device. This certificate allows you to legally market and distribute the device in Russia.

• The registration certificate is typically valid for 5 years, after which you will need to apply for a renewal.

Where to Apply for Class I Medical Device Registration

The application for Class I medical device registration is processed through the Roszdravnadzor official portal. This is the primary and most efficient method of applying.

1. Online Application:
   • Portal URL: Roszdravnadzor Portal
   • Register your company, complete the registration form, and upload all required documents.
2. Physical Application (if necessary):
   • In rare cases, Roszdravnadzor may require you to submit original documents or certain files in paper form.
   • Mailing Address:
     • Federal Service for Surveillance in Healthcare (Roszdravnadzor)
     • Address: 3/1, building 1, Kirovogradskaya St., Moscow, Russia, 117420
3. Authorized Representative:
   • If you are an international company, appointing a local authorized representative is mandatory. They will submit the application and track the process on your behalf.

Summary of Key Steps:

1. Prepare your documents (product description, CFS, IFU, etc.).
2. Register on the Roszdravnadzor portal and create an account.
3. Complete the registration form on the portal.
4. Upload the required documents and submit the application.
5. Pay the registration fee via the portal.
6. Wait for the review and approval from Roszdravnadzor.
7. Receive your registration certificate after successful approval.

For foreign companies, appointing a local authorized representative is crucial to handle the submission and communication with Roszdravnadzor.

By following this process and ensuring that your documentation is complete and accurate, you can successfully register a Class I medical device for sale in Russia.

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