To apply for Class 2A medical device registration in Russia with Roszdravnadzor (RZN), the application process is managed through RZN’s official portal and can be done either online or offline, depending on the specific submission process at the time. Here's where and how you can apply:

Where to Apply for Class 2A Medical Device Registration

1. Online Application via Roszdravnadzor's Official Portal:

   • Roszdravnadzor offers an online application submission platform for medical device registrations, including for Class 2A medical devices.
   • The official portal for medical device registration is the Unified State Register of Medical Devices (EGRMD), which is managed by Roszdravnadzor.
   • The portal allows you to submit your registration application, track the status of your submission, and receive notifications about the progress of your application.

2. Roszdravnadzor's Official Website:

   • Visit the official Roszdravnadzor website (www.roszdravnadzor.ru) for detailed information on the registration process, required documents, and links to the online application system.
   • On the website, you can find the specific registration forms, guidance documents, and instructions on how to submit an application electronically or through paper submission.

3. Postal Application (If Applicable):

   • If online submission is not possible or if a paper application is required, you can submit the application to the Roszdravnadzor regional office or to the central office in Moscow via postal mail.
   • The physical address for submitting the application is:
     • Federal Service for Surveillance in Healthcare (Roszdravnadzor)
       Address: 11, 4th Veshnyakovsky Lane, Moscow, 109017, Russia.
   • Note: This option is less common and generally used for situations where online submission is not feasible.

4. Local Representative:

   • If you are a foreign manufacturer, your local representative in Russia (usually a registered distributor or regulatory consultant) can submit the registration application on your behalf through the Roszdravnadzor portal. They will handle the entire submission process and act as your point of contact for the registration process.
   • The local representative must be a legal entity registered in Russia and authorized by the manufacturer via a power of attorney.

Steps to Apply Online via Roszdravnadzor's Portal

1. Register on the Portal:

   • Before submitting an application, you (or your local representative) will need to create an account on the Roszdravnadzor portal for medical device registration.
   • This portal is where all documentation will be uploaded and where updates on your application can be monitored.

2. Prepare Required Documentation:

   • Ensure that all required documents (such as technical documentation, clinical data, ISO certifications, and translations into Russian) are ready before starting the submission process. These will be uploaded to the portal as part of the registration application.

3. Complete the Registration Form:

   • Fill out the registration form available on the portal with all necessary details about the Class 2A medical device (e.g., manufacturer details, device description, intended use, labeling, and certification).
   • The online form will guide you through the process and request the specific information required by Roszdravnadzor.

4. Pay the Registration Fee:

   • You will be required to pay the registration fee online through the portal. The fee payment is an essential part of the submission process.

5. Submit the Application:

   • Once all the necessary information is filled out and the documentation is uploaded, you can submit the application electronically through the portal.
   • After submission, you will receive an acknowledgment of receipt from Roszdravnadzor.

6. Monitor Application Status:

   • The portal allows you to track the status of your application and receive notifications if additional information is requested by Roszdravnadzor or when the registration certificate is issued.

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