Medical Device Toxicological Studies in Russia from September 1, 2026

Foreign medical device manufacturers registering products in Russia from September 1, 2026 need to follow revised toxicological study requirements. This guide covers study scope, documents, timelines, testing organizations, application review, and final results.

Foreign manufacturers preparing to register a medical device in Russia after September 1, 2026 need to take into account a revised procedure for toxicological studies. The changes affect several practical parts of the process, including application review, study timelines, reasons why a testing organization may be unable to conduct the required studies, and the document issued at the end of the assessment.

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

Toxicological studies are used to assess the biological safety of medical devices and accessories that come into direct or indirect contact with the human body, including contact with the skin, mucous membranes, or body tissues. The purpose of the studies has not changed, but the way the process is handled and documented has.

For projects already in progress around the September 1 transition date, the key factor is when the application for toxicological studies was submitted. Applications filed before September 1, 2026 continue under the previous procedure.

TL;DR: Key Changes to Medical Device Toxicological Studies from September 1, 2026

New rules apply from September 1, 2026. Toxicological studies are conducted under Russian Ministry of Health Order No. 421n.

A protocol replaces the previous conclusion. Study results are now documented in a toxicological study protocol.

Applications are reviewed within 10 business days. Once a decision is made, the applicant must be notified within three business days.

The reasons why studies may not proceed are defined more clearly. These include issues with the testing organization's accreditation scope or technical capability, as well as non-compliant applications or supporting documents.

Toxicological studies normally take up to 30 business days. An extension of up to 20 business days is possible when the applicable method or methodology requires additional time.

The scope of studies depends on how the device interacts with the human body. Sanitary-chemical, biological, and, where applicable, microbiological parameters may be assessed under a study program developed for the specific device.

What Changed in Medical Device Toxicological Studies in Russia from September 1, 2026?

From September 1, 2026, toxicological study results are documented in a toxicological study protocol instead of a conclusion, applications are reviewed within up to 10 business days, and applicants must be notified of the decision within three business days. The rules also define more clearly when studies cannot be performed and allow the standard 30-business-day study period to be extended by up to 20 business days only when a longer duration is required by the applicable method or methodology.

Key Changes to Medical Device Toxicological Studies in Russia from September 1, 2026

Area	Before September 1, 2026	From September 1, 2026
Document issued after the studies	Results were documented in a conclusion.	Results are documented in a toxicological study protocol.
Extension of study timelines	The period could be extended by agreement with the applicant for up to 20 business days; cases where the methodology itself required more time were considered separately.	An extension of up to 20 business days is linked directly to the duration required by the applicable method or methodology. The applicant must be notified within three business days.
Application review	Applications and documents were reviewed within up to 10 business days, but no separate three-business-day notification period was established for the decision.	Review still takes up to 10 business days, but the applicant must now be notified of the decision within three business days.
Cases where studies cannot proceed	The applicant was informed of the reasons for a negative decision, but the grounds were less specifically defined.	The rules expressly identify issues such as insufficient accreditation scope, equipment problems or scheduled work, and non-compliant applications or documents.
Application submission	Submission methods were not separately listed in the toxicological study provisions in the same way.	Applications may be submitted in person, by registered mail, or electronically by email with an electronic signature.
Format of the final result	The conclusion was provided to the applicant under the previous procedure.	The protocol may be issued on paper or as an electronic document.

For a foreign manufacturer, the practical takeaway is that a study plan prepared under the previous procedure should not automatically be reused for a new registration project. Before filing an application, it is important to confirm which procedure applies, whether the selected testing organization can perform the required study program, and whether the documentation meets the current requirements.

For a broader overview of the medical device conformity assessment changes that took effect in Russia on September 1, 2026, including changes beyond toxicological studies, see our article «New Medical Device Conformity Assessment Rules in Russia from September 1, 2026.»

Which Medical Devices Require Toxicological Studies in Russia?

Toxicological studies are generally required for medical devices and accessories that come into direct or indirect contact with the human body during use. The required scope depends on the type and duration of contact, the device's intended use, and the parts of the product that interact with the body.

This means that biological safety cannot be assessed in the same way for every product. A device that briefly contacts intact skin, for example, will not require the same scope of assessment as an implantable device intended for long-term contact with internal tissues.

For a foreign manufacturer, one of the first practical questions is therefore which parts of the device contact the body, what type of contact occurs, and for how long. These characteristics directly affect the study program that will be required.

How Do Medical Device Toxicological Studies Work in Russia in 2026?

Medical device toxicological studies in Russia follow a defined process: the application and supporting documents are reviewed first, then the study program is prepared and approved, the agreement is concluded, and the medical device and required accessories are submitted for testing. The studies are then performed under the approved program and applicable methods, and the results are documented in a toxicological study protocol.

Medical Device Toxicological Studies in Russia Follow Six Main Stages:

1. Application and document submission.
The applicant submits the application and supporting documentation in person, by mail, or electronically.

2. Application review.
The testing organization has up to 10 business days to determine whether the required studies can be performed.

3. Study program preparation.
If the application is accepted, the study program is prepared together with the applicant and approved by the head of the testing organization.

4. Agreement and submission of the device.
Once the program is approved and the agreement is concluded, the applicant provides the medical device and required accessories.

5. Toxicological studies.
The studies are performed in accordance with the approved program and applicable methods.

6. Documentation of results.
Once the work is completed, the applicant receives a toxicological study protocol.

What Is Evaluated During Medical Device Toxicological Studies in Russia?

Medical device toxicological studies in Russia evaluate whether the device and its accessories are biologically safe under their intended conditions of use. The scope is determined individually for each device based on its intended use, characteristics, and especially the type and duration of contact with the human body. Depending on these factors, the assessment may include sanitary-chemical, biological, and microbiological parameters, as well as a review of whether the device, its documentation, and the planned study methods are sufficient to confirm biological safety.

Parameters Assessed During Toxicological Studies:

• compliance of the medical device and its accessories with applicable standards and regulatory, technical, and operating documentation;
• compliance of the technical and operating documentation with the applicable requirements;
• correctness of the assigned potential risk class;
• the nature and duration of contact between the device and the human body;
• whether the characteristics and study methods included in the program are sufficient for the particular device;
• sanitary-chemical parameters, including substances that may be released from the device during use;
• biological parameters in vitro and in vivo, with the required biological effects determined according to the intended use and duration of contact;
• microbiological parameters, where applicable;
• the overall safety of the medical device and its accessories based on the study results.

There is no single standard toxicological study package for every medical device. A separate program is developed for each product, defining the required parameters, study methods, and scope of work based on its intended purpose, use, and interaction with the human body.

Who Can Perform Medical Device Toxicological Studies in Russia?

Toxicological studies must be performed by a testing laboratory or testing center accredited in Russia's national accreditation system, and the required work must fall within the organization's accreditation scope. Accreditation alone is not enough. The testing organization must also have the technical capability to perform the specific study program required for the medical device.

The organization may be unable to perform the studies if the necessary work is outside its accreditation scope, if required equipment is unavailable because of malfunction, or if planned work is being carried out on that equipment.

The testing organization must also remain impartial and must not depend on the applicant or other parties interested in the study results.

What Documents Are Required for Medical Device Toxicological Studies in Russia?

For a foreign manufacturer, the document package typically includes the application, manufacturer and authorization documents, technical and operating documentation, information on applicable regulatory documentation, and product-specific materials relevant to biological safety. The testing organization uses these documents to identify the device, understand its intended use and design, assess its biological safety characteristics, and prepare the appropriate study program. The exact package depends on the medical device and its composition.

Core Document Package for Medical Device Toxicological Studies in Russia

1. Application, Manufacturer and Authorization Documents

• the application for toxicological studies;
• documents confirming the authority of the manufacturer's authorized representative, where applicable;
• documentation confirming the registration of the foreign manufacturer;
• proof of authority where another person submits the application on behalf of the applicant.

2. Technical and Product Documentation

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

3. Biological Safety and Other Product-Specific Documents

Where applicable, the package may also include:

• trademark and other identification documentation;
• documentation relating to medicinal products, pharmaceutical substances, biological materials, or other substances used in the manufacture of the device or included in its composition;
• manufacturer evidence relating to the assessment of biological safety.

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

Expert Insight from UCEC Quality LLC: before preparing the toxicological study program, it is important to identify which parts of the medical device come into contact with the human body, the nature and duration of that contact, and which device versions need to be covered by the studies. These factors directly affect the study program, the number of samples required, and the scope of laboratory work.

How Long Does It Take to Review an Application for Toxicological Studies in Russia?

The testing organization has up to 10 business days from receipt of the application and supporting documents to decide whether the required toxicological studies can be performed. The applicant must be notified of the decision within three business days, whether the decision is positive or negative.

If the application is accepted, the next steps are preparation of the study program together with the applicant, approval of the program by the head of the testing organization, and preparation of the draft agreement.

Why Can a Toxicological Study Application Be Rejected in Russia?

A toxicological study application may not proceed for one of two basic reasons: either the testing organization cannot perform the required work, or the application and supporting documentation do not meet the procedural requirements.

Problems on the testing organization's side may include:

• the required studies falling outside its accreditation scope;
• lack of the technical capability to perform the work;
• malfunction of required equipment;
• scheduled work affecting equipment needed for the studies.

Problems with the application may include:

• an application that does not meet the established requirements;
• a supporting document package that does not meet the applicable requirements.

The applicant must be notified in writing within three business days, and the notification must state the specific reasons why the studies cannot proceed.

How Long Do Medical Device Toxicological Studies Take in Russia?

The standard study period is up to 30 business days. If the applicable method or methodology requires additional time, the period may be extended by up to 20 additional business days, bringing the possible study period to as much as 50 business days.

The 30-business-day period begins after the medical device and required accessories have been provided to the testing organization and the work has been paid for under the agreement.

The additional 20 business days are not automatic. An extension is allowed only when a longer duration is required by the applicable study method or methodology. If the study period is extended, the applicant must be notified within three business days after the decision.

For a foreign manufacturer planning a registration timeline, it is therefore important to distinguish between the application review period and the toxicological study period itself.

What Document Is Issued After Medical Device Toxicological Studies in Russia?

From September 1, 2026, the results of toxicological studies are documented in a medical device toxicological study protocol. The protocol may be issued on paper or as an electronic document. The protocol records information about:

• the testing organization;
• the manufacturer or its authorized representative;
• the medical device;
• the documents submitted for the studies;
• the study procedure and conditions;
• the methods used;
• the study results.

What Can Lead to a Negative Toxicological Study Result?

A negative result means that the completed studies do not confirm the required safety of the medical device or identify non-compliance with requirements that need to be demonstrated at this stage of conformity assessment. The reason may relate either to the characteristics of the device itself or to deficiencies or inconsistencies in the technical and operating documentation submitted for assessment.

Key Reasons for a Negative Toxicological Study Result:

• the medical device or its accessories not meeting applicable requirements or declared characteristics;
• sanitary-chemical, biological, or microbiological results that do not allow the device's safety to be confirmed;
• technical or operating documentation that does not meet the applicable requirements;
• insufficient information about the device characteristics or methods needed for a complete assessment;
• inability to confirm safe use of the device under the intended conditions.

A negative study result should not be confused with a testing organization declining to conduct the studies. In the first case, the studies have already been performed, but the results do not confirm the required conformity and safety. In the second, the studies never begin because of issues involving accreditation, equipment, the application, or the supporting document package.

Do the New Toxicological Study Rules Apply to Applications Submitted Before September 1, 2026?

No. If the application for toxicological studies was submitted to the testing organization before September 1, 2026, the studies are completed under the previous procedure. The key date is the application submission date, not the date when the medical device was transferred, the studies actually began, or the final protocol was issued.

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

Medical Device Registration Support in Russia

For medical devices that come into contact with the human body, biological safety should be considered before the toxicological study application is submitted. The nature and duration of contact, device materials, available documentation, required study scope, and the capabilities of the selected testing organization all affect preparation for this stage of conformity assessment.

Unified Center of Expertise and Certification (UCEC Quality LLC) supports foreign manufacturers preparing medical devices for registration in Russia. Our specialists can review the documentation, help determine the required scope of toxicological studies, identify a testing organization with an appropriate accreditation scope, 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, help determine the biological safety assessment requirements for your device, and support preparation for registration under the current requirements.