To register and apply for Class I medical device registration with Roszdravnadzor (RZN) in Russia, the process can be carried out through the official government portal or by directly submitting documents to the regulatory authority. Below are the key steps on where and how to register:

Where to Apply for Class I Medical Device Registration with Roszdravnadzor

1. Online Submission via the RZN Portal

Roszdravnadzor provides an official online portal for submitting medical device registration applications. This is the most efficient method for submitting your application and documentation.

• Official Portal: The portal for medical device registration is hosted by the Federal Service for Surveillance in Healthcare (Roszdravnadzor), and it allows applicants to file documents, track progress, and receive updates electronically.

  • Portal URL: Roszdravnadzor Medical Device Registration Portal

  • On the portal, you will need to create an account, fill out the registration application form, and upload the required documents, including translations, certificates, and product descriptions. If you’re unfamiliar with the portal, it’s helpful to consult with a local representative or regulatory consultant who can guide you through the process.

2. Paper Submission (If Necessary)

In some cases, you may still be required to submit physical copies of certain documents to Roszdravnadzor. This is less common but may be necessary for some specific categories of medical devices.

• Submission Address: The official address of Roszdravnadzor for physical submissions is:
  • Federal Service for Surveillance in Healthcare
  • Address: 3/1, building 1, Kirovogradskaya St., Moscow, Russia, 117420
  Ensure that the documents are complete, translated into Russian, and meet all other regulatory requirements when submitting in paper format.

3. Authorized Representative

If your company is based outside of Russia, you will need to appoint an authorized representative in Russia to submit the application and handle communication with Roszdravnadzor on your behalf.

• The authorized representative is responsible for submitting the application, providing any additional documents requested by Roszdravnadzor, and receiving the registration certificate once it is issued.

Key Steps in the Application Process

1. Create an Account on the Roszdravnadzor portal (if submitting online).
2. Complete the Application Form: Fill out the application form for registration of the Class I medical device.
3. Prepare and Upload Documents: Submit required documents such as:
   • Product description
   • Certificate of Free Sale (CFS)
   • Manufacturing details
   • Instructions for Use (IFU) in Russian
   • Risk management and labeling information
4. Pay Registration Fees: You will be asked to pay the registration fee, which can typically be done via the portal.
5. Roszdravnadzor Review: Roszdravnadzor will process and review your application, which may take several months.
6. Receive Registration Certificate: Once approved, you will receive the registration certificate, allowing you to legally sell and distribute your Class I medical device in Russia.

Conclusion

The primary place to register your Class I medical device with Roszdravnadzor is the official Roszdravnadzor online portal, which allows you to submit applications and track the process electronically. If needed, physical submissions can be made to their Moscow office, but online submission is more common and efficient. Ensure that all documents are translated into Russian and meet the required standards for registration. If you are outside Russia, appointing an authorized representative will be necessary to act as your liaison with the regulator.

Contact Us：

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