Medical Device Clinical Trials in Russia from September 1, 2026

Medical device clinical trials in Russia follow revised rules from September 1, 2026. The new procedure expands the situations requiring human-participant trials, introduces a three-business-day notification period, sets more detailed requirements for the clinical study plan, and updates how results are documented and reported.

Foreign manufacturers preparing to register a medical device in Russia after September 1, 2026 need to take into account revised requirements for clinical trials. The changes affect when clinical trials involving human participants are required, how applications are reviewed, what must be included in the clinical trial program, and how the final results are documented and reported.

The new rules are established by Russian Ministry of Health Order No. 421n of May 13, 2026. They apply to clinical assessment performed as part of the state registration of medical devices in Russia and, where required, amendments to an existing registration dossier.

One of the most important changes from September 1, 2026 concerns when human participation is required. The new procedure expands the relevant cases to include certain design changes affecting a device's functional purpose or operating principle, as well as expanded indications or changes in intended purpose.

For projects already underway around the transition date, the key factor is when the clinical trial application was submitted to the medical organization. Applications filed before September 1, 2026 continue under the previous procedure.

TL;DR: Key Changes to Medical Device Clinical Trials from September 1, 2026

New rules apply from September 1, 2026. Medical device clinical trials are conducted under Russian Ministry of Health Order No. 421n.

Clinical evaluation can still follow two main routes. It may rely on analysis and evaluation of existing clinical data and/or involve human participants.

More situations now require human-participant clinical trials. These include certain design changes affecting device function or operating principle, as well as expanded indications or changes in intended purpose.

Application review takes up to 10 business days. After a decision is made, the applicant must be notified within three business days.

There is no single maximum duration for the clinical trials themselves. The timeline depends on the device, its complexity, the available clinical evidence, and the type of clinical evaluation required.

Human-participant trials require ethics review. The ethics council may take up to 30 business days to review the submitted materials.

The final result is documented in an assessment act. The document may be issued on paper or electronically.

Trial information is reported electronically. Information on the completed clinical trials and the final assessment act is entered into the registration authority's automated information system.

What Changed in Medical Device Clinical Trials in Russia from September 1, 2026?

From September 1, 2026, two additional situations may require clinical trials involving human participants, while application review remains limited to 10 business days and applicants must now be notified of the decision within three business days. The new procedure also defines more clearly when a medical organization cannot conduct the required trials and specifies the information that must be included in the clinical study plan.

The updated rules also provide more detail on electronic documentation and reporting. The final assessment act may be issued electronically, and information on the completed clinical trials and the final act is submitted to the registration authority's automated information system.

The basic process remains the same: the medical organization reviews the documentation, determines whether the clinical assessment can be performed, develops the clinical trial program, and evaluates the safety and effectiveness of the medical device.

Key Changes to Medical Device Clinical Trials in Russia from September 1, 2026

Area	Before September 1, 2026	From September 1, 2026
Human-participant clinical trials	Four main groups of cases were identified.	Two additional situations are expressly covered: certain design changes affecting the device's functional purpose or operating principle, and expanded indications or changes in intended purpose.
Application review	Applications were reviewed within up to 10 business days.	The review period remains up to 10 business days, but the applicant must be notified of the decision within three business days.
When trials cannot proceed	The applicant was informed of the reasons for a negative decision.	The rules now identify more specific grounds, including insufficient licensed medical activities at the selected medical organization and non-compliant applications or supporting documents.
Clinical study plan	The program was prepared by the medical organization together with the applicant.	The new procedure specifies the information that must be included, such as the type of clinical evaluation, study plan, stages, timeline, and device information.
Final documentation and reporting	The final document was an assessment act.	The assessment act remains the final document but may be issued electronically. Information on the trials and the act is also entered into the registration authority's automated information system.

For registration planning, the most important practical question is whether the existing clinical evidence is sufficient or whether additional data must be generated through human-participant trials. That decision can affect the regulatory route, documentation package, ethics review requirements, project timeline, and overall cost.

For a broader overview of the medical device conformity assessment changes introduced in Russia on September 1, 2026, see our article «New Medical Device Conformity Assessment Rules in Russia from September 1, 2026».

What Types of Clinical Evaluation Are Used for Medical Devices in Russia?

Medical devices in Russia can be clinically evaluated in two main ways: through analysis and evaluation of existing clinical data and through clinical trials involving human participants. Depending on the device and the available evidence, these approaches may be used separately or together.

Human participation is therefore not required for every medical device. If the available clinical evidence is sufficient to confirm safety and effectiveness and none of the situations requiring human-participant trials applies, the assessment may be completed on the basis of existing clinical data.

In practice, the first step is to determine what clinical evidence is already available and whether it adequately supports the device's intended use, indications, safety, and effectiveness.

When Are Human-Participant Clinical Trials Required for Medical Devices in Russia?

Human-participant clinical trials are required when the available clinical evidence is not sufficient to confirm the medical device's safety and effectiveness or when additional clinical data must be obtained through use of the device in humans. Under the rules effective from September 1, 2026, this may apply not only to new types of medical devices or products using new complex technologies, but also to certain design changes that affect the device's functional purpose or operating principle, expanded indications for use, changes in intended purpose, and devices containing new or insufficiently studied materials that come into contact with the human body.

Cases Requiring Human-Participant Clinical Trials in Russia

• 1. A new type of medical device is being registered.
• 2. The device uses new complex, unique, or specialized methods or technologies for prevention, diagnosis, or treatment.
• 3. The device design has changed in a way that affects its functional purpose and/or operating principle.
• 4. The indications for use are expanded or the intended purpose of the device changes.
• 5. Analysis and evaluation of the available clinical data do not confirm the device's safety and effectiveness.
• 6. The device contains new materials whose biological effects have not previously been studied, or known materials are used with a new type or longer duration of contact with the human body.

Expert Insight from UCEC Quality LLC: whether human-participant trials will be required should be determined while the registration strategy is still being developed. Their inclusion can significantly affect the registration pathway, required documentation, project timeline, and cost. Depending on the registration procedure, the manufacturer may also need a Roszdravnadzor permit and a positive ethics opinion before the trials can proceed.

How Do Medical Device Clinical Trials Work in Russia in 2026?

The process starts with a review of the existing clinical evidence. Before planning additional studies, the manufacturer should determine whether the available data are sufficient or whether human-participant clinical trials are required. The application and supporting documents are then submitted to an eligible medical organization. If the selected clinical site confirms that it can perform the required assessment, the study plan, scope, and timeline are agreed with the applicant.

If human-participant clinical trials are required, the process may also include obtaining a Roszdravnadzor permit and completing ethics review, depending on the applicable registration procedure. After the clinical evaluation is completed, the medical organization reviews the results and prepares the final assessment act.

Main Stages of Medical Device Clinical Trials in Russia

1. Determine Whether Existing Clinical Evidence Is Sufficient
Available clinical data are reviewed to determine whether they can support the device's safety and effectiveness or whether human-participant trials are required.

2. Prepare the Application and Supporting Documents
The applicant prepares the clinical, technical, and other required documentation. Where applicable, a Roszdravnadzor permit must also be included.

3. Clinical Site Reviews the Application
The selected medical organization reviews the application and supporting documents within up to 10 business days.

4. Confirm That the Required Clinical Assessment Can Be Performed
The applicant is notified within three business days after the medical organization decides whether it can conduct the required clinical trials.

5. Agree the Clinical Study Plan and Timeline
The medical organization determines the expected duration based on the device's intended use and complexity and prepares the clinical study plan together with the applicant.

6. Provide the Medical Device and Required Accessories
The applicant supplies the device and accessories in the quantity specified in the study plan.

7. Complete Ethics Review, Where Required
Human-participant clinical trials require a positive ethics opinion before they can proceed.

8. Evaluate the Clinical Evidence and Conduct Additional Trials, if Required
Existing clinical data are analyzed and evaluated, and human-participant trials are conducted where necessary.

9. Document and Report the Results
The medical organization prepares the assessment act and submits the required information to the registration authority's automated information system.

What Is Evaluated During Medical Device Clinical Trials in Russia?

Clinical evaluation is used to confirm that the medical device performs as intended, that its claimed benefits are supported by clinical evidence, and that it can be used safely under the conditions specified by the manufacturer. The assessment also checks whether the clinical evidence is consistent with the device's intended purpose, indications for use, technical characteristics, and supporting documentation.

Key Clinical Evaluation Criteria for Medical Devices in Russia

• compliance of the medical device with applicable regulatory, technical, and operating documentation;
• consistency of the intended purpose and indications for use with the manufacturer's documentation;
• completeness and reliability of the device characteristics described in the submitted materials;
• quality of the medical device when used as intended;
• effectiveness of the device for the declared purpose and indications;
• safety under the intended conditions of use;
• whether the available clinical data are sufficient to confirm safety and effectiveness.

The assessment may also consider previous clinical studies, scientific publications, information on clinically significant corrective actions and recalls, and data relating to interchangeable medical devices.

Where necessary, the findings may lead to revisions of the device's regulatory, technical, or operating documentation.

Who Can Perform Medical Device Clinical Trials in Russia?

Medical device clinical trials must be conducted by medical organizations that meet the applicable requirements and are included in the Roszdravnadzor list. However, inclusion in the list alone does not mean that an organization can perform clinical trials for every type of medical device. The selected clinical site must also hold a medical license covering the type of care and clinical activities needed for the specific device and planned study.

For a foreign manufacturer, this means that a medical organization should be selected for the specific device and planned clinical program. A facility that is eligible to perform clinical trials in one medical specialty may not necessarily be suitable for a device requiring a different type of medical care.

What Documents Are Required for Medical Device Clinical Trials in Russia?

The document package for medical device clinical trials in Russia typically includes the clinical trial application, manufacturer and authorization documents, technical and operating documentation, information on applicable regulatory documentation, available clinical evidence, and risk assessment materials. Depending on the device and the type of clinical evaluation, the package may also include data from previous studies and clinical use in Russia or other countries, scientific publications, reports and other clinical evidence, information on the methods and results of previous clinical use, and supporting materials confirming the device's safety and effectiveness.

If the clinical evaluation involves human participants, a Roszdravnadzor permit must also be submitted when it is required under the applicable registration procedure. Documents prepared in a foreign language must be accompanied by a certified Russian translation.

The exact document package therefore depends on the medical device, the available clinical evidence, and whether the assessment relies on existing data, requires human-participant trials, or combines both approaches.

Core Document Package for Medical Device Clinical Trials in Russia

1. Application and Authorization Documents

• application for clinical trials;
• documents confirming the authority of the manufacturer's authorized representative, where applicable;
• documents confirming the authority of another person submitting the application on behalf of the applicant, where applicable.

2. Technical and Operating Documentation

• information on the regulatory documentation applicable to the medical device;
• manufacturer's technical documentation;
• operating documentation, including the instructions for use or operating manual.

3. Clinical Evidence and Risk Documentation

• documents and information on previous studies of the medical device;
• data on clinical use of the device in Russia and other countries, where available;
• scientific publications, reviews, reports, and other materials containing relevant clinical data;
• medical device risk assessment materials;
• information on methods and results of previous clinical use;
• supporting evidence relating to the device's safety and effectiveness.

4. Additional Documentation for Human-Participant Clinical Trials

• a Roszdravnadzor permit for clinical trials involving human participants.

Documents prepared in a foreign language must be submitted with a certified translation into Russian.

Expert Insight from UCEC Quality LLC: the intended use, indications, technical and operating documentation, and clinical evidence should describe the same device consistently. Contradictions between these materials can affect the clinical study plan, the amount of additional evidence required, and the final assessment of safety and effectiveness.

How Long Does It Take to Review a Clinical Trial Application in Russia?

Application review takes up to 10 business days from receipt of the clinical trial application and supporting documents. Once the medical organization has decided whether it can conduct the required clinical trials, the applicant must be notified within three business days.

If the application is accepted, the next steps include agreeing the clinical study plan, determining the expected duration, concluding the agreement, and preparing for the clinical evaluation itself.

How Long Do Medical Device Clinical Trials Take in Russia?

There is no single fixed maximum duration for medical device clinical trials under the procedure. The timeline is determined by the medical organization based on the intended use and complexity of the device. In practice, the overall duration can also vary depending on the amount and quality of available clinical evidence, the study plan, and whether human-participant trials are required.

Where human-participant trials are necessary, the project timeline must also account for ethics review, which may take up to 30 business days, together with preparation of the study plan and other required regulatory steps.

When Is a Roszdravnadzor Permit Required for Medical Device Clinical Trials in Russia?

A Roszdravnadzor permit is required for human-participant clinical trials when the applicable state registration procedure requires such authorization. The requirement does not apply to every device or registration route. The procedure provides exceptions for certain cases, including in vitro diagnostic medical devices, medical device software, and some registration dossier amendments and special registration procedures.

The need for a permit should therefore be determined for the specific medical device and registration pathway, rather than based only on its potential risk class.

When Is Ethics Approval Required for Medical Device Clinical Trials in Russia?

Ethics approval is required when clinical trials involve human participants. The approved clinical study plan and the required supporting documents are submitted to the Ethics Council for Medical Devices under the Russian Ministry of Health. The council reviews whether the proposed trials are ethically justified and issues its opinion within up to 30 business days after receiving the documents.

Human-participant clinical trials can proceed only after a positive ethics opinion confirming that the proposed study is ethically justified has been obtained.

Why Might a Clinical Site Be Unable to Conduct Medical Device Clinical Trials in Russia?

A clinical site may be unable to conduct the required trials for two main reasons: either its medical license does not cover the clinical activities required for the specific device, or the application and supporting documentation do not meet the procedural requirements. The applicant must be notified in writing within three business days, and the notification must explain the specific reasons why the clinical trials cannot proceed.

This may occur when:

• the organization's medical license does not cover the type of medical services needed for the device and planned clinical evaluation;
• the application does not meet the established requirements;
• the submitted document package is incomplete or does not meet the applicable requirements.

What Document Is Issued After Medical Device Clinical Trials in Russia?

The final document is an assessment act summarizing the results of the medical device clinical trials. The act summarizes: information about the medical device and the clinical evaluation performed; the clinical data reviewed; the evaluation methods used; the final conclusions on whether the device corresponds to the submitted documentation; conclusions on the device's quality, effectiveness, and safety. The assessment act may be issued on paper or as an electronic document.

An electronic act is signed with the electronic signature of the head of the medical organization or another authorized person and may be sent to the applicant electronically.

Information on the completed clinical trials and the final assessment act is also entered into the registration authority's automated information system.

What Can Lead to a Negative Medical Device Clinical Trial Result in Russia?

A negative result means that the completed clinical evaluation does not confirm the device's declared characteristics, effectiveness, or safety, or shows that the device or its documentation does not meet the requirements assessed at this stage. A negative result may also occur when the available clinical evidence is insufficient or contradictory and does not support use of the medical device for the declared intended purpose and indications.

Main Reasons for a Negative Clinical Trial Result in Russia

• the medical device does not comply with the applicable regulatory, technical, or operating documentation;
• the submitted documentation is inconsistent with the declared intended use or indications;
• the documentation does not adequately support the completeness or reliability of the declared device characteristics;
• the clinical evaluation does not confirm the device's quality, effectiveness, or safety.

A negative clinical trial result is different from a clinical site being unable to conduct the trials.

In the first case, the clinical evaluation has already been performed but does not provide the evidence needed to support the device. In the second, the trials do not begin because issues were identified during review of the application or supporting documentation.

Do the New Clinical Trial Rules Apply to Applications Submitted Before September 1, 2026?

No. If the clinical trial application was submitted to the medical organization before September 1, 2026, the clinical trials are conducted and completed under the procedure that applied before Order No. 421n took effect. The key date is the date the clinical trial application was submitted to the medical organization, rather than the date on which the clinical assessment was completed.

Applications submitted on or after September 1, 2026 are subject to the new procedure.

Medical Device Registration Support in Russia

For foreign manufacturers, clinical assessment should be considered before the clinical trial application is submitted. The available clinical evidence, intended purpose and indications, consistency of the documentation, and the need for human-participant trials can all affect the registration strategy and the scope of additional clinical evidence required.

Unified Center of Expertise and Certification (UCEC Quality LLC) supports foreign manufacturers preparing medical devices for registration in Russia. Our specialists can review the available clinical evidence and documentation, help determine the appropriate form and scope of clinical assessment, assess whether human-participant trials may be required, and prepare the documentation needed for the subsequent registration process.

Planning to register a medical device in Russia? UCEC Quality LLC can review your documentation and existing clinical evidence, help determine the applicable clinical assessment requirements, and support preparation for registration under the current rules.