24 March 2026

Software as a Medical Device: Legal Criteria and Registration Procedure in Russia

March 24, 2026

BRACE Law Firm©

Global digitalization has led to the increasing use of software in medicine. Consequently, Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ"), classifies software as a medical device alongside other instruments, apparatus, and materials used in healthcare.

The Russian Federation permits the circulation of medical devices that have undergone state registration. Software intended for medical care (the "Software") is no exception. Currently, the registration of medical devices may be conducted under the law of the Eurasian Economic Union (EAEU) or the national procedure of the Russian Federation.

This article examines in detail:

the criteria for classifying software as a medical device;
the procedure for registering Software as a medical device under the Russian national procedure;
the specifics of amending the registration dossier for Software; and
the obligations that current legislation imposes on Software manufacturers following state registration as a medical device.

Criteria for Classifying Software as a Medical Device

Under Article 38 of the Law No. 323-FZ, a medical device is software intended by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases; monitoring human health; conducting medical research; or the restoration, replacement, or modification of the anatomical structure or physiological functions of the body; and the prevention or interruption of pregnancy. However, it is often impossible to unambiguously classify software as a medical device based solely on the above definition, which creates numerous practical questions.

According to the clarifications of Roszdravnadzor set forth in Letter No. 02I-297/20 dated February 13, 2020 [1], software constitutes a medical device provided that it meets the following criteria cumulatively:

it represents a computer program or its modules, regardless of the hardware platform used or the methods of software deployment and access;
it is not an integral part of another medical device;
the manufacturer intended it for healthcare purposes; and
the result of the Software's action consists of data interpretation in an automatic mode, including with the use of artificial intelligence technologies, or according to parameters set by a medical professional that affect clinical decision-making.

Furthermore, the regulator indicated that the following methods do not constitute data interpretation: calculations based on set formulas, unit conversions, the construction of statistical reports and graphs, the display of data received from a medical device, signaling deviations, and functions for creating screen forms, business processes, reporting, and other presentations.

The aforementioned clarification from Roszdravnadzor also provides examples of software that are classified as medical devices:

software for a physician to view an anatomical 3D model based on computed tomography images;
software for clinical decision support in cases of stroke;
software to assist a physician in diagnosing specific diseases;
software to assist a physician in performing morphometric measurements; and
software for a radiological picture archiving and communication system (PACS) used for the acquisition, storage, transmission, processing, and viewing of images by a physician [2].

Consider an example provided in the Roszdravnadzor clarifications: software for clinical decision-making regarding the risk of developing colorectal cancer. This Software involves:

an interpretation function — assessing the risk of colorectal cancer development based on available data for high-risk patients when developing individual preventive action plans;
a data set source — medical professionals and diagnostic equipment;
an intended use — use by physicians of various specialties during primary or follow-up appointments;
a hardware platform — a personal computer; and
a method of providing access — the acquisition of a license and electronic media.

In turn, the following is not a medical device:

software intended for the automation of administrative and business activities of a medical organization;
software, including mobile applications, intended by the manufacturer for healthy lifestyle purposes, which measures/calculates the number of steps, walking/running speed, pulse, calories/fluids consumed or burned, weight, body mass index, etc.;
medical information systems of a medical organization, laboratory information systems, software for maintaining electronic medical records, and picture archiving and communication systems, provided that such software does not contain data interpretation functions;
software used to manage a medical device and monitor its operability;
software that uses data received from one or more medical devices but is not intended for healthcare (e.g., software that encrypts and/or aggregates data for further transmission);
software for the exchange of text and/or voice messages, electronic documents, photographic images, and video or audio recordings/streams between a medical professional and a patient, including with the use of telemedicine technologies or for appointment scheduling;
software for the accounting, planning, and monitoring of routine maintenance and repair of medical devices; and
software for an unlimited circle of users for educational, popular science, or reference and information purposes, including for the selection of a medical specialist.

Thus, the criteria for classifying software as a medical device include: its technical nature, autonomy, use for medical purposes, and the possibility of data interpretation.

Classification of Software by Risk Degree

If Software meets the criteria for classification as a medical device, it is classified by risk degree in accordance with Order of the Ministry of Health of Russia No. 4n dated June 6, 2012, On Approval of the Nomenclature Classification of Medical Devices.

Software may be assigned the following classes:

Class 1 – software with a low degree of risk;
Class 2a – software with a medium degree of risk;
Class 2b – software with an increased degree of risk; and
Class 3 – software with a high degree of risk.

The classification of software into risk classes is performed based on the following criteria:

The type of information processed:

information that does not require clarification and/or supplementation for clinical decision-making and indicates the need for immediate and timely action;
information that requires clarification or supplementation for making an informed clinical decision; and
information that does not indicate the need for immediate action.

The software category, which depends on its application conditions:

Category A, if the Software is intended for emergency healthcare; for surgical interventions or complex therapy; or for the diagnosis and/or treatment of diseases that pose a high risk to public or individual health;
Category B, if the Software is intended for urgent healthcare; healthcare without surgical intervention; or for the diagnosis and treatment of diseases or conditions of a patient that pose a moderate risk to public health; and
Category C, if the Software is intended for elective healthcare; healthcare using non-invasive methods or for long-term care; or for the diagnosis or treatment of diseases that pose a low risk to public health.

Software that uses artificial intelligence is always assigned potential risk Class 3. The class is assigned to the software regardless of the potential risk class of the medical device with which it is used.

The subsequent registration procedure depends on the assigned potential risk class.

Rules for Registration of Software Under the Russian National Procedure

The rules for registering medical devices under the national procedure, including software, are approved by Government Decree No. 1684 dated November 30, 2024 (the "Rules for Registration of Medical Devices", the "Decree No. 1684").

The registration authority is the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Decree No. 1684 establishes several types of registration procedures:

standard;
simplified; and
accelerated, depending on the types of devices being registered and their potential risk classes.

Software is registered under simplified and accelerated procedures:

Under the simplified procedure, registration is completed no later than 31 business days from the date the registration authority receives the application and document package.
Under the accelerated procedure, the timeframe for conducting the necessary tests, studies, and document expertise is 25 business days, while registration actions take 10 business days.

The state duty amount for actions related to state registration is determined by Article 333.32.2 of the Tax Code of the Russian Federation. As of the date this article was prepared, the state duties are as follows:

for the issuance of a registration certificate for a medical device – 11,000 rubles;
for conducting the quality, efficacy, and safety expertise of a medical device:

Class 1 – 72,000 rubles;
Class 2a – 104,000 rubles;
Class 2b – 136,000 rubles; and
Class 3 – 184,000 rubles.

In addition to the state duty, the applicant must separately pay for the necessary tests and studies. Authorized organizations calculate the cost of such tests and studies. The methodology for determining the fee amount and their maximum limits are approved by Order of the Ministry of Health and Social Development of Russia No. 1386n dated November 22, 2011.

State registration is perpetual. The fact of state registration is confirmed by a registry entry made in the State Register of Medical Devices (GRMI).

The procedure for registering Software in accordance with Decree No. 1684 is detailed below.

Pre-registration Procedures for Software as a Medical Device

The following pre-registration procedures must be completed before submitting a registration application:

1. Prepare the documentation package for the registration dossier. At the initial stage, developing technical and operating documentation for the software is critical. Requirements for their content are established by Order of the Ministry of Health of Russia No. 181n dated April 11, 2025 [3].

The technical documentation must contain a significant amount of information, including:

a name that allows for the identification of the software and information on the version numbering of such software;
information on its purpose and principles of operation;
information on the potential risk class;
information on the presence (or absence) of artificial intelligence technologies;
information on the hardware platform, the method of software deployment, and the provision of access to it;
a list of risks and a description of methods for managing these risks to reduce them to an acceptable level;
system requirements necessary for the functioning of the software;
information on data exchange protocols;
information on software verification and validation; and
a list of measures and means of protection against unauthorized access to the Software, etc.

The operating documentation for the software must contain:

information on the developer, manufacturer, and authorized representative of the manufacturer;
information on potential consumers;
a description of components, modules, and blocks;
information on the current Software version and requirements for its update;
requirements for the training or qualifications of persons performing Software installation;
information on the need to use antivirus tools and cryptographic protection means; and
information on means used to protect against illegal distribution, etc.

In addition to the specified documentation, other measures and documents must be developed to confirm safety (software testing, validation, and verification reports).

2. Conduct technical and clinical trials of the software. After preparing the documents, one proceeds to the technical and clinical trials of the software to determine its quality and safety. The procedure for conducting trials is regulated by Order of the Ministry of Health of Russia No. 885n dated August 30, 2021 (the "Order No. 885n") [4].

A technical trial is a trial conducted to determine the quality and safety of a medical device and the compliance of its characteristics (properties) with the requirements of regulatory documentation and the manufacturer's technical and operating documentation, as well as to make a subsequent decision on the possibility of conducting clinical trials.

A testing laboratory accredited by the Federal Accreditation Service with the appropriate scope of accreditation may perform technical trials.

The timeframe for conducting technical trials is no more than 30 business days from the date the applicant provides samples of the medical device and the document package listed in paragraph 5 of Order No. 885n. The results of technical trials are documented in an assessment report.

A clinical trial is a designed and planned systematic study of a medical device to evaluate its safety and efficacy.

Clinical trials involving humans are conducted in exceptional cases:

when a new type of medical device is invented;
when using new complex and/or unique and/or special methods for the prevention, diagnosis, and treatment of diseases and conditions, as well as the use of new complex medical technologies;
if the efficacy and safety of the medical device were not confirmed during the analysis and evaluation of clinical data; and
for medical devices containing new materials that contact the human body and have not been previously studied in terms of biological action, or known materials contacting organs or tissues for which there is no experience of medical use (para. 37 of Order No. 885n).

These are conducted only after submitting registration documents based on permit documents. Generally, such trials are not required for Software. In other cases, clinical trials are conducted in the form of clinical data analysis and evaluation.

Clinical trials are conducted in medical organizations that meet established requirements and are included in the corresponding list on the Roszdravnadzor website. Unlike most other medical devices, preliminary permission from Roszdravnadzor is not required to conduct clinical trials for software.

To conduct clinical trials, an application and the document package specified in Order No. 885n are submitted to the selected medical organization. Within 10 business days, the medical organization conducts a preliminary analysis to decide on the possibility of conducting clinical trials. In the event of a positive decision, a clinical trial program is drawn up jointly with the applicant. Clinical trials of software are conducted using patient medical data obtained during diagnosis, treatment, and rehabilitation.

The results of clinical trials are documented in an assessment report of clinical trial results. Information on the conducted trials is entered into the Automated Information System (AIS) of Roszdravnadzor within 3 business days of their completion.

For software with potential risk Class 2b or 3, a production inspection will also be required.

Production inspection is an assessment of the production conditions and the quality management system of the medical device manufacturer. The procedure for its conduct is regulated by Government Decree No. 136 dated February 9, 2022, On Approval of Requirements for the Implementation, Maintenance, and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use.

Currently, only two organizations subordinate to Roszdravnadzor are authorized to conduct inspections: the FSBI "National Institute of Quality" (FSBI "NIK") and the FSBI "All-Russian Scientific Research and Testing Institute of Medical Engineering" (FSBI "VNIIIMT").

After obtaining positive trial results and preparing the documents, the registration application can be submitted to Roszdravnadzor.

Stages of Registering Software as a Medical Device with Roszdravnadzor

1. Submission of the application to Roszdravnadzor.

The registration application is submitted through the applicant's personal account on the Unified Portal of State and Municipal Services (Gosuslugi). The applicant may be the Software manufacturer or its authorized representative. An authorized representative may be a legal entity or an individual entrepreneur residing in the Russian Federation. Foreign manufacturers must have an authorized representative in Russia. Information about the representative is entered into the State Register of Medical Devices (GRMI).

The list of information to be included in the application and the required documents are provided in paragraphs 64 and 86 of Decree No. 1684. Note that for software, additional information must be provided regarding:

the possibility (or impossibility) of classifying it as software using artificial intelligence technologies; and
the presence (or absence) of a built-in function in such Software for the automatic transmission of processed data and software action results to the registration authority's AIS.

In addition to the documents standard for all medical devices, color photographic images of the electronic media and the software interface must be attached to the document package.

2. Acceptance and registration of the application.

Within 5 business days of receiving the application, the registration authority verifies the completeness and reliability of the submitted documents and decides whether to initiate the registration procedure within 3 business days. If it is established that the information in the application or the document package is incomplete, the applicant is given 30 days to rectify the identified non-compliances. If the violations are not rectified, a decision is made to return the submitted application.

3. Conducting the quality, efficacy, and safety expertise of the software.

After the registration procedure begins, the registration authority issues a task to conduct the quality, efficacy, and safety expertise.

Currently, the expertise is conducted by the FSBI "National Institute of Quality" and the FSBI "All-Russian Scientific Research and Testing Institute of Medical Engineering". The procedure for conducting the expertise is approved by Order of the Ministry of Health of Russia No. 206n dated March 20, 2020 [5]. Additionally, the FSBI "VNIIIMT" approved Methodological Recommendations on the Procedure for Conducting the Quality, Efficacy, and Safety Expertise of Software for State Registration within the National System dated May 7, 2024. These Methodological Recommendations detail the procedure for evaluating documentation and trials, as well as the criteria for non-compliance.

The expertise is conducted within 10 business days from the date the registration authority's task is received. During this expertise, an evaluation of the scope and completeness of the conducted trials is also performed. Based on the results of the expertise, the expert institution prepares and sends the corresponding conclusion in hard copy to Roszdravnadzor.

The grounds for an expert institution to issue a conclusion on the impossibility of state registration are:

a) non-compliance of the Software with the requirements of regulatory documentation or the manufacturer's technical and/or operating documentation;

b) absence of evidence of Software quality, efficacy, or safety;

c) failure of the obtained data to confirm the quality, efficacy, or safety of the registered Software;

d) establishment that the risk of harm to the health of citizens and medical professionals due to the use of the Software exceeds the efficacy of its use; and

e) the presence of unreliable information in the documents contained in the registration dossier, identified based on the results of state control.

A negative conclusion from the expert institution serves as grounds for refusing state registration. The applicant may submit objections to the conclusion within 10 business days through the personal account on the Gosuslugi portal. The registration authority considers the objections with the involvement of the expert institution within 30 business days and decides whether to recognize the objections as substantiated and send the conclusion for revision, or to refuse.

4. Deciding on state registration (or refusal of state registration).

After receiving the conclusion, Roszdravnadzor:

decides whether to register the Software as a medical device or to refuse registration and notifies the applicant of the decision through the personal account on the Gosuslugi portal; and
in the event of a positive decision, makes the corresponding entry in the State Register of Medical Devices.

Specifics of Registering Software with Artificial Intelligence Under the Accelerated Procedure

An accelerated registration procedure is provided for software with artificial intelligence intended for processing medical images obtained during radiological studies.

In such cases, clinical trials are conducted at the GBUZ "Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow City Health Department".

The registration application and document package are submitted to the expert institution in hard copy. The document expertise is conducted within a reduced timeframe of 25 business days and, in the event of a positive conclusion, the application is sent to the registration authority. If the conclusion is negative, the applicant is given 35 business days to correct the submitted document package.

Within 10 business days of receiving a positive conclusion, the registration authority verifies the completeness and reliability of the information and decides whether to register the Software or provides a reasoned refusal.

Registration of Medical Devices Based on the Internet of Things (IoMT)

Significant achievements in wireless technology have led to the development of medical devices capable of collecting, analyzing, and transmitting medical data. The Internet of Medical Things (IoMT) is a network of interconnected medical devices and applications that collect, analyze, and transmit data in real-time. IoMT typically includes:

medical devices that allow for the reading of necessary medical indicators;
software that collects, processes, and transmits data;
information transmission channels and cloud storage services; and
receiving devices (computer, smartphone, tablet, etc.).

An example is medical devices that allow medical personnel to remotely monitor patient indicators (blood pressure, heart rate, glucose levels, etc.) using special applications. Furthermore, such devices are beginning to be used in medicine for other tasks: tracking maintenance and replacement schedules for consumables, monitoring critical environmental parameters, etc. However, as we can see, only part of such a complex is actually a medical device.

As researchers of this problem point out [6], since such complexes are used for healthcare and making clinically significant decisions, they fall under the status of "medical devices" and are subject to state registration. At the same time, despite active implementation in medical activities and the obvious specificity of such medical devices, their legal regime, including registration specifics, has not yet been regulated. Therefore, such medical devices are currently registered under general rules, similar to other instruments, apparatus, and equipment.

Procedure for Amending the Registration Dossier for Software Under Decree No. 1684

During the use of software, it may become necessary to amend the documents provided during registration. Decree No. 1684 provides two procedures for such amendments regarding Software:

the standard procedure provided for any medical devices; and
a simplified amendment procedure for software using artificial intelligence technologies.

The simplified procedure applies when it is necessary to amend software version numbering (provided it does not affect the functional purpose). This is possible if the Software has a built-in function for the automatic transmission of its operation data to Roszdravnadzor.

For this purpose, it is sufficient to submit an application through the personal account on the Gosuslugi portal indicating:

the software name;
the registration number and the date of its state registration;
information on the software version to be entered into the state register;
payment of the state duty (date and number of the payment order); and
the applicant's liability for the reliability and identity of the information contained in the registration dossier and the application for amendments.

The timeframe for considering such an application and making a decision is 5 business days.

In other cases, the standard procedure applies. Note that in cases listed in paragraph 111 of Decree No. 1684 (e.g., changes in information about the Software manufacturer or its authorized representative; changes in the manufacturing site address if the change is caused by the renaming of a geographical object; changes in the validity periods of documents contained in the registration dossier, etc.), such amendments are made without conducting a quality, efficacy, and safety expertise. In other cases, such an expertise will be required to amend the registration dossier. More details on the procedure for amending the registration dossier can be found in our special article on this topic [7].

Post-registration Safety Monitoring of Medical Software

After registering software as a medical device, the manufacturer must conduct safety monitoring (Part 1 of Article 96 of Law No. 323-FZ). This includes the collection, processing, registration, and analysis of information on adverse events related to the circulation of medical devices and the making of corresponding decisions. The procedure for conducting monitoring is established by Order of the Ministry of Health of the Russian Federation No. 980n dated September 15, 2020.

Furthermore, an additional obligation to conduct clinical monitoring has been introduced for potential risk Class 3 medical devices, including software. The essence of this monitoring is that for 3 years after obtaining registration, the manufacturer must collect information on the safety and clinical efficacy of the software. Clinical monitoring is conducted in accordance with a plan included in the registration dossier, which must contain:

a) the goals and tasks of clinical monitoring, taking into account available clinical data, specific features, and risk factors related to the medical device; and

b) the clinical monitoring scheme, including the justification for methods (ways) of obtaining and statistically analyzing clinical data, the choice of the study population, inclusion (exclusion) criteria, the minimum number of subjects in the study group, and, where applicable, the need to include comparison groups in the study.

The clinical monitoring report is submitted by the manufacturer to Roszdravnadzor no later than February 1 of each year. The report form is approved by Order of the Ministry of Health of Russia No. 1113n dated October 19, 2020 [8].

Thus, after registering software as a medical device, its manufacturer assumes obligations to analyze information on possible adverse events and take appropriate measures.

In conclusion, it should be noted that software used for healthcare must be registered as a medical device. However, clear criteria for classifying software as a medical device have not yet been established at the legislative level, which increases the risks of software developers being held liable for the sale of unregistered medical devices.

Russian legislation regulating the procedure for registering medical devices has made significant strides in recent years by establishing registration specifics for software as a medical device. However, these legislative changes are not keeping pace with scientific and technical progress, and registration remains a lengthy and costly process. It is necessary to continue improving regulatory control by establishing special rules for testing and registering software.

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References

[1] Roszdravnadzor Letter No. 02I-297/20 dated February 13, 2020, On Software.

[2] Roszdravnadzor Letter No. 02I-297/20 dated February 13, 2020, On Software.

[3] Order of the Ministry of Health of Russia No. 181n dated April 11, 2025, On Approval of Requirements for the Content of Technical and Operating Documentation of the Manufacturer (Producer) of a Medical Device.

[4] Order of the Ministry of Health of Russia No. 885n dated August 30, 2021, On Approval of the Procedure for Assessing the Compliance of Medical Devices in the Form of Technical Trials, Toxicological Studies, and Clinical Trials for the Purpose of State Registration of Medical Devices.

[5] Order of the Ministry of Health of Russia No. 206n dated March 20, 2020, On Approval of the Procedure for Organizing and Conducting the Quality, Efficacy, and Safety Expertise of Medical Devices.

[6] G. S. Lebedev, I. A. Shaderkin, I. V. Fomina, A. A. Lisnenko, I. V. Ryabkov, Internet of Medical Things // Journal of Telemedicine and E-Health, No. 3, 2017.

[7] See: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/vird-medicinskih-izdelij-nacionalnaya-procedura-rf.

[8] Order of the Ministry of Health of Russia No. 1113n dated October 19, 2020, On Approval of the Procedure for Reporting by Subjects of Medical Device Circulation on All Identified Cases of Side Effects Not Specified in the Instructions for Use or the Operating Manual of a Medical Device, Adverse Reactions During Its Use, Specifics of the Interaction of Medical Devices with Each Other, and Facts and Circumstances Creating a Threat to the Life and Health of Citizens and Medical Professionals During the Use and Operation of Medical Devices.