How to Locate Medical Device Registration Information on the Roszdravnadzor Website

If you need to verify a registration certificate, review user instructions, or view images for a medical device registered in Russia, the official Roszdravnadzor website is the definitive resource. Here’s how to navigate the site for quick and accurate information:

• Simple Search:
  Enter the product name, registration certificate number, or product type directly into the search bar. This streamlined option is ideal for straightforward queries.
• Advanced Search:
  For more detailed information, use the advanced search tool. This feature lets you input additional criteria about the device, helping you narrow down your results more effectively.

Visit the official Roszdravnadzor site to access the comprehensive Register of Russian Medical Devices, where you can confirm registration details and gather all related documentation.

If you have any questions about locating a registration certificate or require further assistance, the experts at UCEC “QUALITY” LLC are ready to help. We offer professional services for preparing documents needed for technical, toxicological, and clinical test authorizations. With our extensive knowledge of regulatory requirements and continuous monitoring of legislative updates, we ensure a fast and cost-effective registration process.

For reliable guidance on medical device registration in Russia, trust UCEC “QUALITY” LLC to support your needs every step of the way.

What Is the State Register of Russian Medical Devices?

The State Register is the official government database that provides comprehensive details on all medical devices and health product manufacturers that have completed the national registration process in accordance with Russian Federation standards.

While various online resources may offer information about medical devices, only the official Roszdravnadzor website—which hosts the State Register—ensures reliable and up-to-date data. This accuracy is maintained through the continuous efforts of the federal health oversight authority to update the register regularly.

Access the electronic Register of Medical Devices here: https://roszdravnadzor.gov.ru/services/misearch.
How to Find Information About a Medical Device on the Roszdravnadzor Website

Starting March 1, 2022, in line with the Government Resolution No. 1416 (dated December 27, 2012) approving the Rules for State Registration of Medical Devices, the Roszdravnadzor website now provides enhanced details—including photos and usage instructions—for registered medical devices.

Follow these steps to locate a license or registration certificate for a specific health product:

1. Visit the Website:
Go to Roszdravnadzor and click on the “Services” (Сервисы) section.

2. Access the State Register:
Navigate to the State Registry of Medical Devices and Organizations (or individual entrepreneurs) involved in the production of health-related products..

3. In the search bar, enter the product name or the registration certificate number for the device designed for health purposes.

4. If you do not have the complete product name or certificate number, use the advanced search option to provide additional product details.

5. Once you have entered all the necessary information, the system will display the relevant search results.

6. Click on the page for the specific medical device to view its registry entry. This page will include links to download the registration certificate, instructions, and related images. Follow the appropriate link to access the required details.

Simple Search Option

The simple search tool allows you to find a registration certificate by entering its number or the product name directly on the Roszdravnadzor website. If you are unsure of the complete product name, you can enter a partial term; the system will then display a broader set of results based on your keywords. Additionally, you can export the search results to an Excel file for further analysis.

Advanced Search Option

For more refined queries, the advanced search tool offers extensive filtering capabilities. You can search using criteria such as:

• Registration certificate number
• Date of the registration procedure
• Validity period of the registration certificate
• Details about the manufacturer (individual entrepreneur or organization, including name, legal address, and location)
• Potential risk category (1, 2a, 2b, 3)
• OKPD 2 code
• Product purpose in the health and wellness sector
• Location of the manufacturing organization
• Medical device classification code
• Information on interchangeable products
• Registry entry number

Like the simple search, the advanced search results can also be saved in Excel format.

What Information Does a Registration Certificate Contain?

A registration certificate includes comprehensive details that confirm the device’s compliance and safety. Key information provided in the certificate includes:

• Taxpayer Identification Number (TIN)
• Date of issuance and expiration date
• Name of the manufacturing enterprise
• Device name
• Links to technical specifications or standards detailing the equipment requirements
• Assigned potential risk category for the device
• Approval statement regarding the device’s usage
• Director’s signature and the official seal of the federal health oversight authority

This certificate guarantees that the device has undergone the necessary testing as per regulatory standards and is officially registered, ensuring its safe use without compromising patient safety.

Professional Assistance for Obtaining a Registration Certificate

If you lack the time or expertise to thoroughly review the regulations or wish to avoid the hassle of multiple registration attempts due to incomplete documentation, consider partnering with experienced professionals. Our expert team can help streamline the registration process and prevent repeated government fees associated with re-submitting applications.

Our certification center offers specialized support for obtaining registration certificates for medical devices. We are also available to provide detailed consultations on navigating the Roszdravnadzor website to locate the registration certificate you need.