How to Verify a Medical Device Registration in Russia?

To confirm that a medical device is legally registered in Russia, the State Register maintained by Roszdravnadzor is the authoritative source. Search can be performed by registration number, device name, or manufacturer, and the entry should be checked for validity and current active status before purchasing, supplying, or signing a distribution agreement.

If you need to confirm that a medical device is registered in Russia, the most reliable source is the State Register of Medical Devices maintained by Roszdravnadzor, Russia's federal healthcare regulator. Do not rely only on a copy of a registration certificate provided by a manufacturer, distributor, or supplier - the current registry entry should also be checked.

A medical device can be searched by its registration number, registered device name, or manufacturer. Once the correct entry is found, check that it matches the product and documentation you are reviewing, and confirm the registration validity and the status of the current registry entry.

This type of verification is particularly useful before purchasing or supplying a device in Russia, signing a distribution or supply agreement, reviewing a manufacturer's documentation, or confirming that a specific model is covered by an existing Russian registration.

Medical device registration in Russia is currently governed by Government Resolution No. 1684 of November 30, 2024. The State Register itself is maintained under Government Resolution No. 1650 of September 30, 2021.

How to Check If a Medical Device Is Registered in Russia?

To verify a Russian medical device registration, find the device in Roszdravnadzor's State Register, open the current registry entry, and compare the registered information with the device and documents you are checking. The registration number is usually the best place to start if it is available.

A practical verification can be completed in seven steps:

1.Open the Roszdravnadzor State Register of Medical Devices.

Use the official Roszdravnadzor online registry rather than third-party databases when confirming the legal registration status of a device.

2.Search for the device using one of the available identifiers.

The registration number, registered device name, and manufacturer can be used to locate the record. The search methods are explained below.

3.Select and open the correct registry entry.

If several results appear, identify the correct record by device name, manufacturer, model, or configuration, then open it to review the official registration information.

4.Compare the registry entry with the documents and product being checked.

The registration number, registered device name, and manufacturer should correspond to the documentation you have received. If you are checking a specific model or configuration, confirm that it is covered by the relevant registration entry.

5.Check the registration validity.

The registry shows either an expiration date or indicates that the registration is indefinite.

6.Confirm that you are viewing the current registry entry.

If the registration information has been amended in the past, older versions may remain visible in the history. Use the latest active version of the record.

Expert Insight from Unified Center of Expertise and Certification: if the registration number is available, use it first. Searching by device name or manufacturer can return several similar records, which means additional identification will be required before you can confirm that you have found the correct medical device.

How to Find a Medical Device Registration in the Roszdravnadzor Register?

A medical device registration can be found in the Roszdravnadzor State Register by registration number, registered device name, or manufacturer. If the registration number is available, it is usually the most precise search option because it leads directly to a specific registration record and reduces the risk of confusing the device with products that have similar names.

Search Methods in the Roszdravnadzor Register

Searching by Registration Number

If the registration number is known, use it as the first search criterion. This is usually the fastest and most precise way to find the correct record and reduces the risk of confusing the medical device with products that have similar names.

Registration numbers from previously issued certificates can also be searched in the current Roszdravnadzor State Register. Enter the registration number exactly as it appears in the original certificate or other registration documents, then open the matching record and confirm that the device name and manufacturer correspond to the product you are checking.

Searching by Medical Device Name

If the registration number is not available, search by the medical device name. The commercial or brand name used on packaging or in marketing materials may differ from the official name under which the device is registered in Russia. If an exact match does not appear, try the full registered name or the most distinctive part of the device name.

If several results appear, use the manufacturer, model, or configuration to identify the correct entry.

Searching by Manufacturer

You can also search by the medical manufacturer's official name. This is useful if you need to identify the Russian registration number for a particular product or review the registered medical devices associated with a specific manufacturer.

If several devices from the same manufacturer appear, compare the registered device name, model, and configuration before relying on the result.

How to Check Whether a Medical Device Registration Is Valid in Russia

Open the medical device record in the Roszdravnadzor State Register and check two things: the registration validity period and the status of the current registry entry. The registration should either have a valid expiration date or no fixed expiration date, and the current registry entry should be marked as «active».

If changes have been made to the registration, earlier versions of the record may remain available in the registry history. These previous entries make it possible to review what information changed and when, while the current active entry shows which registration data applies to the medical device today.

If your review shows that the registered information needs to be updated, see our Registration Certificate Modifications for Medical Devices service page for details on updating a medical device registration in Russia.

Expert Insight from Unified Center of Expertise and Certification: an indefinite registration confirms that the registration itself has no fixed expiration date. An active registry status confirms that the record being reviewed is the current version of the registration information.

Why Verify a Medical Device Registration Before Supplying Products to Russia?

Before supplying a medical device to Russia, it is important to confirm that the registration is still valid and the current State Register entry matches the product being supplied. This helps identify situations where the manufacturer, device name, model, configuration, or other registered information has changed since the original registration.

A Russian medical device registration may remain valid for many years, while the information associated with the device can be amended over time. Checking the current registry entry helps confirm that:

• the registration is still valid;
• the current registry entry is active;
• the manufacturer information is up to date;
• the product being supplied corresponds to the registered medical device;
• the relevant model or configuration is covered by the registration;
• amendments made after the original registration are reflected in the current record.

This is particularly important before starting supplies to Russia, signing a distribution agreement, participating in public procurement, or reviewing a manufacturer's regulatory documentation.

For foreign manufacturers, the check is also useful when a product has been registered in Russia for several years. The registration certificate originally issued for the device may still be valid, while some of the registered information may have changed since then.

The practical question is therefore not only: "Do we have a valid Russian medical device registration?"

It is also: "Does the current registration still cover the medical device we are supplying to Russia today?"

Medical Device Registration Support in Russia

Checking the Roszdravnadzor State Register is a practical way to confirm that a medical device is registered, review the validity of its registration, and identify the current version of the official registry entry. For products that have been registered for many years, checking the latest entry is particularly important because the registration data may have been amended since the original certificate was issued.

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 medical device manufacturers and suppliers throughout the registration process - from reviewing documentation and preparing the registration dossier to coordinating required testing, working with expert organizations, and interacting with Roszdravnadzor.

We also assist with amendments to Russian medical device registrations and other regulatory issues related to placing medical devices on the Russian and EAEU markets.

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