Russia Proposes New Medical Device Risk Indicators for 2026

Russia's Ministry of Health has proposed four new risk indicators for medical device oversight — covering adverse event reporting gaps, outdated registration dossiers for Class 2b and 3 devices, data mismatches in public procurement, and manufacturing addresses that don't match registration records — and while the draft is not yet in force it gives manufacturers a clear picture of where regulatory attention is heading.

Companies selling medical devices in Russia may soon need to pay closer attention to how their registration data, labeling, manufacturing information, and public procurement records match across different systems.

The Russian Ministry of Health has prepared draft changes that would add four new risk indicators to the system used by Roszdravnadzor (Russia's Federal Service for Surveillance in Healthcare) for state oversight of medical devices.

The draft was prepared on July 29, 2026 and would amend Ministry of Health Order No. 368n of July 17, 2023, which contains the current list of risk indicators used in medical device oversight.

The most important point for manufacturers is that the new indicators are not yet in force. As of September 2, 2026, the document remains a draft. The four proposed indicators have not yet been added to the current rules.

Still, the proposal is worth reviewing now. It shows which types of inconsistencies Roszdravnadzor may begin paying more attention to - especially where a medical device has been on the Russian market for many years.

TL;DR: What Is Changing for Medical Devices in Russia in 2026

• Russia's Ministry of Health proposes adding four new risk indicators for medical device oversight.
• A healthcare organization could attract regulatory attention if it has not reported adverse events involving medical devices for a specified period.
• A Class 2b or Class 3 medical device could become subject to closer review if it is still being sold while its registration dossier has not been updated for more than 10 years.
• A discrepancy between the device name or intended purpose used in Russia's public procurement system and the information in the official State Register of medical devices could become a risk indicator.
• A manufacturing address shown on the product labeling could also become a risk indicator if it does not match the address recorded in the registration documents.
• A risk indicator does not automatically mean that a violation has occurred. It gives Roszdravnadzor a reason to review the situation more closely and determine whether further regulatory action is needed.
• The new indicators are not yet in force and will apply only after the Russian Ministry of Health formally adopts the amendments and they enter into effect.

What Are Russia's New Medical Device Risk Indicators for 2026?

Russia's Ministry of Health proposes four new risk indicators for medical device oversight. They cover adverse event reporting, outdated registration dossiers for Class 2b and Class 3 devices, discrepancies in public procurement data, and manufacturing addresses that do not match registration records. If adopted, the four indicators would become items 6-9 of Ministry of Health Order No. 368n.

Proposed Medical Device Risk Indicators in Russia for 2026

Proposed risk indicator	What Roszdravnadzor would review
No adverse event reports for an extended period	How long a healthcare organization has gone without submitting adverse event reports related to the use of medical devices
No changes to the registration dossier for more than 10 years	Whether Class 2b or Class 3 devices continue to be marketed even though their registration dossiers have not been amended for more than 10 years
Inconsistent information in public procurement records	Whether the device name and intended purpose listed in Russia's Unified Information System for Public Procurement (EIS) match the information in the State Register of Medical Devices
Manufacturing site address does not match registration data	Whether the manufacturing address shown on the medical device labeling is included in the registration certificate or official register entry

The proposed changes focus heavily on one issue: consistency of information across different stages of a medical device's lifecycle.

A medical device may be properly registered in Russia, but problems can still arise if the information used later in labeling, procurement, manufacturing, or supply no longer matches the official registration data.

We examined the practical business consequences of outdated or inconsistent registry data in more detail in our earlier article, “The Severe Business Risks of Outdated Registry Data in Russia.”

Expert Tip from «Unified center of Expertise and Certification»: for medical device manufacturers and suppliers, this means that a valid registration alone may not be enough to avoid regulatory questions. Information used after registration - for example, on labeling, in procurement records, or in relation to manufacturing sites - should remain consistent with the official registration data.

What Does a Roszdravnadzor Risk Indicator Actually Mean?

A risk indicator is not proof of non-compliance. It is a predefined parameter that Roszdravnadzor uses to identify organizations, products, or situations that may require closer regulatory attention. It is a part of Russia's risk-based regulatory oversight system.

The identification of a risk indicator does not automatically mean that a company or healthcare organization has violated mandatory requirements. Instead, it signals that the available information meets certain criteria that may justify further regulatory review.

If a risk indicator is identified, the process may look like this:

• Roszdravnadzor receives or analyzes information related to the circulation or use of a medical device.
• The information is compared against the established risk indicators.
• Roszdravnadzor identifies that a regulated entity or medical device meets one of those indicators.
• An authorized official prepares a reasoned submission proposing a supervisory measure.
• Roszdravnadzor may then conduct the relevant control or supervisory activity to determine whether mandatory requirements are being met.

This mechanism is provided for by Article 61.1 of Federal Law No. 248-FZ of July 31, 2020, Russia's main federal law governing state and municipal control and supervision.

Who Could Be Affected by Russia's New Medical Device Risk Indicators in 2026?

The proposed indicators could affect healthcare organizations, medical device manufacturers, manufacturers' authorized representatives, suppliers, and companies participating in public procurement. The relevant trigger depends on the participant: healthcare organizations would be affected by adverse event reporting, while manufacturers and suppliers would need to pay particular attention to registration dossiers, procurement data, labeling, and manufacturing site information.

Who Needs to Pay Attention to the New Risk Indicators?

Market participant	What requires attention
Healthcare organizations	Periods during which no adverse event reports have been submitted, taking into account the applicable risk category
Manufacturers and authorized representatives of Class 2b and Class 3 medical devices	Registration dossiers that have remained unchanged for more than 10 years while the devices continue to be marketed
Companies participating in public procurement	Whether the device name and intended purpose used in procurement records match the information in the State Register of Medical Devices
Manufacturers and manufacturers' authorized representatives	Whether manufacturing site addresses shown on product labeling correspond to the official registration information

From a compliance perspective, the common theme behind all four proposed indicators is data consistency.

The regulator is increasingly able to compare information from different stages of a medical device's lifecycle: registration, manufacturing, labeling, distribution, public procurement, and actual use by healthcare organizations.

Expert Tip from «Unified center of Expertise and Certification»: in practical terms, the draft increases the importance of keeping medical device information accurate and up to date throughout the entire product lifecycle - from the registration dossier and manufacturing site information to labeling, supply, and use within healthcare organizations.

For foreign manufacturers, this is particularly important because registration and post-registration information in Russia may be maintained through a local authorized representative. Information used by distributors, procurement participants, and other parties should therefore remain consistent with the official registration data.

When Will Russia's New Medical Device Risk Indicators Take Effect?

As of September 2, 2026, the four proposed medical device risk indicators have not yet entered into force. The Ministry of Health draft remains pending, which means there is currently no confirmed effective date for the new indicators.

The new indicators cannot be treated as effective requirements until the relevant order has been formally adopted and entered into force.

However, the draft already gives companies a clear indication of the areas that may receive greater regulatory attention once the changes are adopted.

The final wording may still change. The effective date may also be revised during the approval process.

How Should Medical Device Manufacturers Prepare for Russia's 2026 Risk Indicator Changes?

The proposed changes make the accuracy of registration data, labeling, manufacturing information, and information contained in government systems increasingly important. For manufacturers and other companies whose medical devices remain on the Russian market, this is a good time to review whether the information associated with those devices is still accurate and consistent across different sources.

Particular attention should be given to:

• Class 2b and Class 3 medical devices that have been registered for a long period;
• registration dossiers that have not been updated for more than 10 years;
• manufacturing sites and the addresses associated with them;
• manufacturing information shown on medical device labeling;
• device names and intended purposes used in Russian public procurement;
• consistency between commercial and procurement information and the official State Register of Medical Devices.

The main problem is often not a missing document. It is a mismatch between documents or systems. A discrepancy can arise when information has changed over time in one source but has not been updated in another.

For example, manufacturing information may have changed while the labeling or registration data still reflects an earlier version. Similarly, the way a medical device is described in procurement documentation may not fully correspond to its registered name or intended purpose.

Reviewing these issues before the new indicators enter into force can help manufacturers and their authorized representatives identify inconsistencies early and determine whether amendments to the registration documentation are required.

Key Russian Medical Device Regulatory Terms

Russian Ministry of Health - the federal authority responsible for healthcare policy and medical device regulation in Russia.

Roszdravnadzor - Russia's federal healthcare regulator responsible for oversight of medical devices and compliance.

Risk Indicator - a predefined condition that may trigger closer regulatory review. It does not automatically mean that a violation has occurred.

Registration Dossier - the set of regulatory documents supporting a medical device registration.

Registration Certificate - the official document confirming that a medical device is registered in Russia.

State Register of Medical Devices - Russia's official database of registered medical devices.

Unified Information System in Procurement (EIS) - Russia's government system for public procurement.

Manufacturer's Authorized Representative - a person or organization representing a medical device manufacturer in regulatory matters in Russia.

Class 2b and Class 3 Medical Devices - higher-risk medical device categories under the Russian classification system.

EAEU - the Eurasian Economic Union, which has its own regulatory framework for medical devices.

Medical Device Registration and Regulatory Support in Russia and the EAEU

The proposed changes show that Russian regulators are placing greater emphasis on the accuracy and consistency of medical device information throughout the product lifecycle. For manufacturers, this means that registration data, manufacturing information, labeling, and procurement records should be reviewed as a connected system rather than as separate compliance tasks. Companies with products already on the Russian market may benefit from checking these areas before the new risk indicators take effect.

Unified Center of Expertise and Certification (LLC UCEC "Quality") is one of the leading companies in the field of medical device registration in Russia and the Eurasian Economic Union (EAEU). We support manufacturers both during market entry and after registration, helping them keep regulatory documentation accurate and up to date.

Our specialists can assist with:

• medical device registration in Russia and the EAEU;
• review of registration documentation and registration dossiers;
• preparation and filing of amendments;
• review of manufacturing site information;
• review of medical device labeling and related regulatory data.

Planning to register a medical device in Russia or the EAEU? Contact our specialists for support with document preparation, the registration procedure, and bringing your medical device to market.