How to Obtain an Official Medical Device Registry Extract in Russia?

A medical device registry extract in Russia serves as an official electronic document confirming registration data currently held in the Roszdravnadzor State Register — available free of charge via Roszdravnadzor or Gosuslugi, issued the same day, and used for supply preparation, procurement, due diligence, and confirming that registered details still correspond to the product being supplied.

If you need official proof of a medical device's registration in Russia, you can request an electronic extract from the State Register of Medical Devices. Issued by Roszdravnadzor (Russia's federal healthcare regulator) the extract confirms the registration information currently recorded for a specific medical device.

The request can be submitted online through Roszdravnadzor or Gosuslugi (Russia's federal public-services portal) using the device's Russian registration number. The service is free, the extract is issued on the same day, and the document includes a QR code linking directly to the corresponding record in the State Register.

The current procedure has been in place since June 17, 2026, following amendments introduced by Russian Government Resolution No. 708 of June 8, 2026.

For foreign manufacturers, distributors, and regulatory teams, the difference between a registry entry and an official registry extract is straightforward. The online registry lets you check the current registration information, while the extract gives you that information in an official electronic document issued by Roszdravnadzor and suitable for situations where documentary confirmation is required.

What Is an Official Medical Device Registry Extract in Russia?

An official medical device registry extract is an electronic document issued from the Roszdravnadzor State Register for a specific registered medical device. It brings the key registration information together in a formal document and is electronically signed by an authorized Roszdravnadzor official.

The extract is useful when simply viewing the online registry is not enough and the registration information needs to be documented or shared in an official form. This may be required when:

• reviewing a manufacturer's or supplier's regulatory documentation;
• confirming registration details before supply or procurement;
• providing registration evidence to a distributor, customer, or business partner;
• checking registered manufacturer or manufacturing-site information;
• supporting regulatory or commercial due diligence.

If you only need to confirm whether a device is registered and whether the current registry entry matches the product being supplied, see our guide «How to Verify a Medical Device Registration in Russia.»

What Information Is Included in a Russian Medical Device Registry Extract?

A Russian medical device registry extract gives you a detailed snapshot of how a specific device is officially registered in Russia. In addition to the registration number and validity, it can show who the registered manufacturer and authorized representative are, where the device is manufactured, how it is classified, what its intended purpose is, and which supporting materials are included in the State Register.

Depending on the device and the information available in the registry, the extract includes:

• the registered medical device name;
• the date of state registration;
• the Russian medical device registration number;
• the registration validity period;
• the intended purpose defined by the manufacturer;
• the medical device type under the Russian nomenclature classification;
• the medical device risk class;
• the Russian product classification code (OKPD2);
• manufacturer information;
• information about the manufacturer's authorized representative;
• the manufacturing or production-site address;
• information about interchangeable medical devices;
• images of the device, models, accessories, labeling, and packaging;
• for software as a medical device, images of the software interface and relevant media, labeling, and packaging where applicable;
• electronic operating documentation, including instructions for use or the operating manual.

For a foreign manufacturer, the value of the extract is that it allows the Russian registration to be reviewed as a whole rather than checking only whether a registration number exists. It can help confirm whether the manufacturer, manufacturing site, intended purpose, classification, product documentation, and other registered details still correspond to the medical device being supplied or reviewed today.

This is particularly useful when preparing for supply, working with a new distributor, reviewing an older Russian registration, or checking whether changes made by the manufacturer have also been reflected in the Russian registration data.

How to Request a Medical Device Registry Extract in Russia

There are two official ways to request a medical device registry extract online in Russia:

• 1. through the Roszdravnadzor State Register of Medical Devices; or
• 2. through Gosuslugi (Russia's federal public-services portal).

Both services provide the same type of official electronic extract. The main difference is how the request is submitted and which Russian online service the applicant has access to.

For foreign manufacturers, the Roszdravnadzor route may be more straightforward when the relevant device record is already known.

Requesting an Extract Through the Roszdravnadzor State Register

The Roszdravnadzor State Register is the most direct route when the medical device is already known and the corresponding registry entry can be located. The extract request is submitted from the device record itself, so the first step is to make sure that the correct registration entry has been identified.

The process is:

1. 1. Open the official State Register of Medical Devices. Use the Roszdravnadzor registry rather than a third-party medical device database.
2. 2. Find the correct medical device. Search by the Russian registration number, registered device name, or other available search criteria.
3. 3. Open the relevant registry entry. Confirm that the record corresponds to the medical device for which the extract is required.
4. 4. Select the option to request a registry extract. The request function is available from the medical device record.
5. 5. Complete the electronic request. Check the selected device information and provide the required applicant details. The request must meet the electronic-signature requirements applicable to the registry service.
6. 6. Receive the electronic extract. Roszdravnadzor issues the extract electronically and signs it with the qualified electronic signature of an authorized official.

Before submitting make sure that the selected record actually corresponds to the medical device, manufacturer, and registration you need to document.

If the company does not use Russian government electronic services directly, the request can be coordinated through the manufacturer's authorized representative in Russia or a local regulatory specialist.

How to Request a Medical Device Registry Extract Through Gosuslugi?

Gosuslugi (Russia's federal public-services portal) provides a second official online route for obtaining a medical device registry extract. This option is convenient when the applicant already has access to an authenticated Gosuslugi account and knows the Russian registration number of the device.

The process is:

1. 1. Sign in to Gosuslugi and open the service for obtaining extracts from official registers.
2. 2. Select the category for other types of permits.
3. 3. Choose medical device state registration as the relevant type of authorization.
4. 4. Confirm the applicant information. The portal will prefill some information from the account; check that it is correct.
5. 5. Enter the medical device registration number. The Russian registration number is used to identify the device for which the extract is requested.
6. 6. Submit the electronic request. Once processed, the official registry extract is provided electronically.

This route does not require searching for the device first in the Roszdravnadzor registry. If the registration number is already available, it can be entered directly in the Gosuslugi request to obtain the corresponding electronic extract.

How Long Does It Take to Obtain a Medical Device Registry Extract in Russia?

An electronic extract is issued on the same day Roszdravnadzor receives the request. This is one of the changes introduced in June 2026. Under the previous procedure, provision of registry information could take up to five working days. The information is provided free of charge, and no state fee is charged for issuing the extract.

Who Can Request a Medical Device Registry Extract in Russia?

A medical device registry extract is not limited to the manufacturer, authorized representative, or original registration applicant. Because the information in the State Register is publicly available, an extract can be requested by an individual, company, government authority, or other party that needs official confirmation of the registered information.

This makes the extract useful not only for manufacturers, but also for distributors, suppliers, procurement teams, business partners, and organizations carrying out regulatory or commercial due diligence.

For foreign companies, the main practical consideration is not eligibility to obtain the extract, but access to the Russian electronic service used to submit the request.

How Does the QR Code on a Russian Medical Device Registry Extract Work?

The QR code on the electronic registry extract provides a direct link to the corresponding medical device record in the Roszdravnadzor State Register. It allows the recipient of the extract to move from the official document to the online registry and check the registration information currently available for that device.

This is particularly useful when the extract is being reviewed by a distributor, customer, procurement team, or another party that wants to confirm the information against the official Russian register.

The QR code was introduced under the updated registry procedure that took effect in June 2026. It connects the formally issued electronic extract with the corresponding online registration record.

This is important because registration information can change over time. The extract provides an official record of the information issued in response to the request, while the State Register provides access to the current registry data and, where available, the history of previous amendments.

When Do I Need a Medical Device Registry Extract in Russia?

An official registry extract is useful when simply checking a medical device in the online State Register is not enough and the Russian registration information needs to be documented, shared, or formally reviewed. It provides an official electronic record that can be used in regulatory, commercial, procurement, and due-diligence processes.

A registry extract may be particularly useful when:

• preparing to supply a registered medical device to Russia;
• providing registration information to a distributor, customer, or business partner;
• reviewing regulatory documentation before entering into a distribution or supply agreement;
• confirming the current registration details of a device that has been registered in Russia for several years;
• checking whether changes to the manufacturer or manufacturing site are reflected in the Russian registration;
• preparing documentation for procurement or contractual review;
• carrying out regulatory or commercial due diligence on a registered medical device.

For foreign manufacturers, the extract can also help answer a more practical question than simply whether a registration exists: does the official Russian registration information still correspond to the product, manufacturer, manufacturing site, and documentation being used today?

If the goal is only to confirm that a medical device is registered and review its current status, checking the State Register may be sufficient. When that information needs to be provided as an official electronic document, a registry extract is the more appropriate option.

Medical Device Registration Support in Russia

An official registry extract provides documentary confirmation of the information contained in the Roszdravnadzor State Register. It is especially useful when registration information needs to be presented or reviewed as an official electronic document rather than checked only through the public registry interface.

Unified Center of Expertise and Certification (UCEC Quality LLC) is one of the leading companies in medical device registration in Russia and the EAEU. Our specialists support foreign manufacturers throughout the registration process, including documentation review, preparation of registration dossiers, required testing, registration amendments, and work with Russian registry information.

Need to register a medical device in Russia? UCEC Quality LLC can review your documentation and support the entire registration process, from initial assessment through registration approval.