State Registration of Medical Devices in Russia: Comprehensive Guide to the National Procedure and Decree No. 1684

 

February 4, 2026

BRACE Law Firm©

 

Circulation of medical devices is permitted in the territory of the Russian Federation only after they have undergone state registration. This registration process confirms their quality and safety.

Currently, medical devices may be registered under either the law of the Eurasian Economic Union (the "EAEU") or the national procedure. Although registration under EAEU rules was slated to become mandatory as early as 2022, the Russian Government has once again extended the deadline for registration under national rules. [1] Under the adopted amendments, medical devices may be registered under the national rules provided that the application is submitted by the end of 2027.

This article provides a detailed analysis of the rules for the registration of medical devices (the "medical devices" or "MDs") in accordance with Russian legislation.

Which Medical Devices are Subject to Registration?

According to Article 38 of 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" or the "Law on Health Protection"), medical devices include any instruments, apparatus, units, equipment, materials, and other products used for medical purposes, either separately or in combination, and intended by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, restoring, replacing, or modifying the anatomical structure or physiological functions of the body, or preventing or terminating pregnancy, provided that their functional purpose is not achieved through pharmacological, immunological, genetic, or metabolic effects on the human body.

Consequently, any products used to provide medical care to humans, except medicinal products, may be classified as medical devices.

As a general rule, medical devices are subject to registration. Exceptions are set forth in Part 5 of Article 38 of the Law on Health Protection. The following medical devices are not subject to state registration:

• Medical devices listed in Paragraph 11 of Article 4 of the Agreement on Unified Principles and Rules for the Circulation of Medical Devices within the Framework of the EAEU dated December 23, 2014, specifically those imported for:
  • personal use by individuals within the customs territory of the EAEU;
  • use by employees of diplomatic missions and consular offices;
  • provision of medical assistance to passengers and crew members of vehicles, train crews, and drivers of vehicles arriving in the EAEU territory;
  • provision of medical assistance to participants in international cultural and sporting events and international expeditions, as well as for exhibitions;
  • conducting research (testing), including for scientific purposes;
  • use as humanitarian aid;
  • those manufactured in an EAEU member state based on individual patient orders exclusively for personal use.
• Medical devices imported into the Russian Federation for the provision of medical assistance based on the life-saving indications of a specific patient pursuant to a permit from the Government of the Russian Federation;
• Medical devices produced in Russia for export and not intended for use within the EAEU, as well as those produced in Russia for experimental design work, research (testing);
• Medical devices intended for use within an international medical cluster or in the territories of innovative scientific and technological centers;
• Medical devices consisting of sets, kits, assemblies, and first-aid kits composed of registered medical devices (excluding medical devices connected to or equipped with a power source) and/or medicinal products combined in a single package, provided that the secondary (consumer) packaging or primary packaging of each device and/or medicinal product within such sets is preserved along with its labeling;
• Medical devices intended for the diagnosis of diseases by testing human biological samples outside the human body (in vitro), if they are manufactured and used within the same medical organization that produced them.
• Thus, the vast majority of medical devices are subject to state registration.

Rules for Registration under the National Procedure of the RF

The rules for the registration of medical devices under the national procedure were approved by Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024 (the "Registration Rules" or "Decree No. 1684" or the "New Registration Rules").

The regulatory body for MDs is the Federal Service for Surveillance in Healthcare (the "Roszdravnadzor").

One may categorize the procedures as follows:

1. Standard registration procedure, which applies to high-risk MDs requiring clinical trials involving human subjects.
2. Simplified registration procedure, which applies to MDs with a low degree of potential risk.
3. Accelerated registration procedure for domestic medical devices.

What are the Timelines for Medical Device Registration in Russia?

Under the standard procedure, the regulatory body completes state registration of a medical device within a period not exceeding 50 business days from the date the decision to initiate the procedure is made. However, this period does not include pre-registration activities such as necessary testing and research, the collection of the registration dossier (the set of documents submitted by the applicant for the state registration of a medical device), or the time required for clinical trials conducted during the registration process.

In practice, the time required for registration under the standard procedure generally ranges from six months to 1.5 years or more, depending on the type and class of the medical device.

Under the simplified procedure, registration must be completed no later than 31 business days from the date the application and document package are received by the regulatory body.

Under the accelerated procedure, the period for conducting necessary tests, research, and expertise of documents is 25 business days, while registration actions take 10 business days.

State registration is perpetual. The fact of state registration is confirmed by a registry entry made in the State Register of Medical Devices (the "GRMI"). Registration certificates are no longer issued in paper form.

The following sections detail the procedure for registering medical devices in accordance with Decree No. 1684.

Pre-registration Procedures

The Registration Rules establish that state registration is conducted based on:

• results of technical trials;
• toxicological studies;
• clinical trials;
• expertise of the quality, efficiency, and safety of medical devices;
• manufacturing inspection;
• trials for the purpose of pattern approval of measuring instruments (for medical devices classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health).

Technical trials, toxicological studies, measurement instrument trials, and manufacturing inspections are conducted during the stage of collecting documents for registration. These pre-registration procedures are described in more detail below.

Technical Trials of Medical Devices in Russia

Technical trials of MDs are tests conducted to determine the quality and safety of a medical device, the compliance of its characteristics (properties) with the requirements of regulatory documentation and the manufacturer’s technical and operational documentation, as well as to decide on the feasibility of conducting clinical trials.

Technical trials are conducted for medical devices that require clinical trials involving human subjects. In other cases, the manufacturer may collect evidence of safety and efficiency independently.

The procedure for conducting these trials is regulated by Chapters II-III of Order of the Ministry of Health of Russia No. 885n dated August 30, 2021, On Approval of the Procedure for Conducting Conformity Assessment of Medical Devices in the Form of Technical Trials, Toxicological Studies, and Clinical Trials for the Purpose of State Registration of Medical Devices. [2] (the "Order No. 885n").

Technical trials may be performed by a testing laboratory accredited by the Federal Accreditation Service with the appropriate scope of accreditation.

During technical trials, the following are established:

• compliance of the device with the requirements of regulatory, technical, and operational documentation;
• completeness and objectivity of the characteristics established in the technical documentation that are subject to control;
• quality of the medical device and the safety of its use;
• the potential risk class of the medical device.

Note that the potential risk class of a medical device is determined in accordance with Order of the Ministry of Health of Russia No. 4n dated June 6, 2012. [3] According to this order, every medical device must be assigned to exactly one class:

• Class 1 – medical devices with a low degree of risk;
• Class 2a – medical devices with a medium degree of risk;
• Class 2b – medical devices with an increased degree of risk;
• Class 3 – medical devices with a high degree of risk.

The period for conducting technical trials is not more than 30 business days from the date the applicant provides samples of the medical device and the document package. The results of technical trials are documented in an assessment report.

Toxicological Studies of Medical Devices

Toxicological studies of MDs are studies conducted to evaluate their biological safety.

These are conducted for medical devices whose use involves contact with the human body (body surface, mucous membranes, internal environments of the body).

The procedure for toxicological studies is regulated by Chapter IV of Order No. 885n.

As with technical trials, toxicological studies may only be conducted by accredited testing laboratories with the appropriate scope of accreditation.

Toxicological studies include:

• determination of sanitary and chemical indicators;
• assessment of biological effects based on the type and duration of the medical device’s contact with the human body;
• microbiological testing (research).

The period for toxicological studies is 30 business days from the date samples of the MD and the document package are provided. Based on the results, a conclusion is issued.

Clinical Trials of Medical Devices

A clinical trial is a developed and planned systematic study of a medical device undertaken, including with human participation as subjects, to evaluate the safety and efficiency of the medical device.

Clinical trials of medical devices are conducted in the form of:

• research (analysis and evaluation of clinical data);
• trials involving human subjects.

Trials involving human subjects are conducted in the following cases:

a) a new type of medical device;

b) the use of 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;

c) if the efficiency and safety of the medical device were not confirmed during the analysis and evaluation of clinical data;

d) for medical devices containing new materials in contact with the human body that have not been previously studied regarding biological effects, or known materials contacting human organs or tissues for which there is no prior medical experience, or if such contact is more prolonged than previously studied.

These trials are conducted only after documents are submitted for registration and based on authorizing documents. These trials are discussed in more detail in the section titled Stages of Registration at Roszdravnadzor. In other cases, clinical trials of medical devices are conducted in the form of clinical data analysis and evaluation.

Clinical trials of medical devices (excluding in vitro diagnostic medical devices) are conducted in medical organizations. Such medical organizations must meet the following requirements:

• possession of a license to perform medical activities with works (services) based on the purpose and scope of application of the medical devices being tested;
• the charter of the medical organization must include the following types of activity: scientific (research and development) activity and the conduct of clinical trials of medical devices;
• the presence of an intensive care and resuscitation unit (in the case of clinical trials involving human subjects for MDs classified as classes 2b and 3);
• the presence of standard operating procedures regulating the conduct of clinical trials;
• ensuring the protection of confidential information;
• ensuring that information about the conducted trials is entered into the AIS of the regulatory body.

Requirements for medical organizations conducting clinical trials for in vitro diagnostic medical devices differ in several details.

The list of medical organizations permitted to conduct clinical trials is posted on the official website of Roszdravnadzor.

Clinical trials are conducted based on a permit from Roszdravnadzor, with some exceptions (e.g., medical devices with a low degree of potential risk, software). To conduct clinical trials, an application, a package of documents, and samples of the medical device are submitted to the chosen medical organization. Within 10 business days, the medical organization conducts a preliminary analysis to decide on the feasibility of the clinical trials. In the event of a positive decision, a clinical trial program is developed jointly with the applicant. The applicant has the right to monitor the clinical trial at all stages by appointing qualified persons and through monitoring or independent evaluation.

The results are documented in an assessment report. Information regarding the trials must be entered into the Roszdravnadzor AIS within three business days of their completion.

Trials for the Purpose of Pattern Approval of Measuring Instruments

Trials for the purpose of pattern approval of measuring instruments are tests conducted to determine the metrological and technical characteristics of the MD.

These are conducted only for medical devices classified as measuring instruments. The list of such medical devices and the trial procedure are approved by Order of the Ministry of Health of Russia No. 257n dated April 29, 2025, On Approval of the List of Medical Devices Classified as Measuring Instruments in the Sphere of State Regulation of Ensuring the Uniformity of Measurements, and the Procedure for Conducting Their Trials for the Purpose of Pattern Approval of Measuring Instruments. The list includes 15 groups of measuring instruments, such as thermometers, scales, tonometers, etc.

Trials are conducted by legal entities accredited in the field of ensuring the uniformity of measurements to perform trials of reference materials or measuring instruments.

The results are documented in a trial report, a draft description of the measuring instrument pattern, and the medical device verification methodology.

Manufacturing Inspection

Manufacturing inspection is an assessment of the production conditions and the quality management system of the medical device manufacturer.

It is mandatory for the registration of Class 2a medical devices (if sterile), Class 2b, and Class 3 devices.

The procedure is regulated by Decree of the Government of Russia No. 136 dated February 9, 2022, On Approval of Requirements for the Implementation, Maintenance, and Assessment 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: FGBU National Institute for Quality (the "FGBU NIK") and FGBU All-Russian Scientific Research and Testing Institute of Medical Engineering (the "FGBU VNIIIMT").

The inspection evaluates the MD production, control, document management, and other processes.

The inspection period cannot exceed 90 business days from the date the application is submitted. The results are documented in a report on the compliance of the quality management system with the requirements of GOST ISO 13485-2017.

Note that applicants may independently choose testing organizations that meet these requirements. The registries of accredited organizations are available on the Federal Accreditation Service website. However, it is critical to select the testing facility carefully to avoid a refusal of registration. This is illustrated by judicial practice.

For example, in Matter No. A40-126860/2022, [4] a company filed a lawsuit against Roszdravnadzor to challenge a refusal to issue a registration certificate for a medical device. During the proceedings, it was established that the technical trials were conducted by a laboratory whose accreditation certificate lacked the necessary scope for such testing. Roszdravnadzor concluded that the results did not fully confirm the medical device’s compliance with regulatory and technical documentation and refused registration. The court agreed with the regulator and dismissed the claim.

All the above procedures are completed before submitting the registration application, and the resulting documents are included in the registration dossier.

Amount of the State Fee for Medical Device Registration

The amounts of the state fee for actions related to the state registration of medical devices, including the expertise of quality and safety, are defined by Article 333.32.22 of the Tax Code of the RF. As of the date of this article, the state fees are as follows:

• for the issuance of a registration certificate for a medical device – 11,000 rubles;
• for conducting an expertise of the quality, efficiency, and safety of a medical device:
  • Class 1 – 72,000 rubles;
  • Class 2a – 104,000 rubles;
  • Class 2b – 136,000 rubles;
  • Class 3 – 184,000 rubles.

In addition to the state fee, tests and studies are paid for separately.

The cost of such tests and studies is calculated by the authorized organizations. The methodology for determining the amount of payment is approved by Order of the Ministry of Health and Social Development of Russia No. 1386n dated November 22, 2011.

Stages of Registration of Medical Devices at Roszdravnadzor

State registration of medical devices is conducted on an application basis by submitting an application and a package of documents to the regulatory body.

The manufacturer or its authorized representative may act as the applicant. An authorized representative must be a legal entity or an individual entrepreneur residing in the Russian Federation. Foreign manufacturers must have an authorized representative in the RF. Information about the representative is entered into the State Register of Medical Devices (the "GRMI", the "Register").

The application and documents are submitted via the applicant’s personal account on the Unified Portal of State and Municipal Services. The list of information and attached documents depends on whether registration is conducted under the standard, simplified, or accelerated procedure. These lists are provided in Paragraphs 67, 87, and 101 of Decree No. 1684 and are exhaustive.

The timelines and sequence of administrative procedures are established by the Administrative Regulation for the provision of the state service for the state registration of medical devices. [5] The registration stages are as follows:

1. Receipt and Registration of the Application. After receiving the application, the regulatory body decides whether to initiate the registration procedure within three business days of the submission. If the information or document package is incomplete, the applicant is given 30 days to rectify the deficiencies. Failure to do so results in the return of the application.

2. Conducting Expertise of Quality, Efficiency, and Safety Based on an Assignment. Once the procedure begins, the regulatory body issues an assignment for the expertise of the quality, efficiency, and safety of the medical device. Currently, the expertise is conducted by FGBU NIK and FGBU VNIIIMT.

The expertise procedure is approved by Order of the Ministry of Health of Russia No. 206n dated March 20, 2020. [6] It is conducted in two stages:

Stage 1 – Expertise of the application to determine the feasibility of clinical trials (excluding Class 1 MDs, software, and in vitro diagnostic devices). The period for this stage is 20 business days from the receipt of the assignment. The expert institution then issues a conclusion on whether clinical trials are possible.

Stage 2 – Expertise of the completeness and results of technical trials, toxicological studies, and clinical trials conducted before registration, as well as measurement instrument trials. The period for this stage is 10 business days from the receipt of the assignment. The expert institution then issues a conclusion on the efficiency and safety of the MD.

For Class 1 MDs and in vitro diagnostic devices, the expertise of the application and documents is conducted simultaneously with the expertise of the test and study results.

The expert institution may not request additional documents directly from the applicant. If information is incomplete, a request is sent through Roszdravnadzor. The applicant must respond via their personal account within 50 business days.

A negative expert conclusion serves as grounds for a refusal of state registration. Under Decree No. 1684, the applicant is now entitled to submit objections to the conclusion within 10 business days via the State Services portal. The previous registration rules did not provide for this. The regulatory body considers the objections within 30 business days and decides whether to acknowledge them and return the conclusion for revision or to issue a refusal.

3. Conducting Clinical Trials. Clinical trials involving human subjects are conducted based on:

• a clinical trial permit issued by Roszdravnadzor;
• an ethics council conclusion on the ethical feasibility of the clinical trials, issued by the Ethics Council of the Ministry of Health.

Notification of the permit is sent to the applicant’s account after Stage 1 of the expertise.

Ethics Council meetings are held at least twice a month. The period for issuing the ethical feasibility conclusion is 30 business days from the date documents are received for review.

4. Resumption of the State Registration Procedure. Upon completion of clinical trials, the applicant submits an application to resume the registration procedure. The regulatory body makes a decision on resumption within two business days.

5. Evaluation of the Expert Conclusion and Final Decision. Roszdravnadzor evaluates the final expert conclusion and decides whether to grant state registration or issue a refusal.

Under the New Registration Rules, the regulatory body may refuse registration in the following cases:

• receipt of an expert institution's conclusion indicating the impossibility of conducting human clinical trials;
• receipt of an expert institution's conclusion indicating the impossibility of state registration, and/or a decision by the regulatory body that the applicant’s objections are wholly or partially unfounded;
• discovery by the regulatory body, through market surveillance, of discrepancies between the actual efficiency and safety data and the data provided in the application.

Features of Registering Domestic Medical Devices

To accelerate the market entry of domestic medical devices, the New Registration Rules establish specific features for their registration.

According to Paragraph 24 of the Registration Rules, medical devices are considered domestic if they meet two conditions:

• the manufacturer is a Russian legal entity or individual entrepreneur;
• the manufacturer has its own production site within Russia.

The applicant may choose to register under any of the three procedures: standard, simplified, or the specific domestic procedure.

In the latter case:

• the document package is submitted in paper form;
• technical, toxicological, and measurement trials are conducted at FGBU VNIIIMT, while clinical trials are held at medical organizations within the network of national medical research centers;
• clinical trials are conducted based on an ethics council conclusion; no Roszdravnadzor permit is required;

Document expertise is conducted within a reduced timeframe of 25 business days. In the event of a negative conclusion, the applicant is given 35 business days to correct the documents.

Within 10 business days of receiving a positive conclusion, the regulatory body verifies the data and decides on registration.

Features of State Registration in Case of a Risk of Shortage

Due to restrictive measures against the Russian Federation, the Government established specific features for registering certain types of medical devices.

Simplified registration applies to medical devices in the event of a shortage or a risk of a shortage. This procedure is established by Decree of the Government of the RF No. 552 dated April 1, 2022, On Approval of the Features of Circulation, Including the Features of State Registration, of Medical Devices in Case of a Shortage or Risk of Shortage Due to the Introduction of Restrictive Economic Measures Against the Russian Federation (the "Decree No. 552").

The list of medical devices subject to these rules is determined by an interdepartmental commission under the Ministry of Health and is published on the Roszdravnadzor website.

Registrations granted under this procedure are valid until December 31, 2028.

The procedure features shortened timelines: 15 business days for expertise and seven business days for the final decision. Low-risk non-sterile devices may be registered within five business days. However, after registration, the applicant must provide samples for testing at FGBU VNIIIMT. The results must be submitted to Roszdravnadzor no later than 150 days after registration.

Registration of Medical Devices Intended for Use in Military Operations

Decree of the Government of Russia No. 430 dated April 3, 2020, [7] establishes registration features for batches of medical devices intended for use in military operations, emergency situations, or for the prevention and treatment of diseases that pose a danger to others or conditions resulting from chemical, biological, or radiation factors.

The list of such devices is provided in Appendix No. 1 to Decree No. 430.

Applications are submitted electronically or in paper form. Before applying, devices undergo technical, toxicological, and clinical trials according to standard programs developed by Roszdravnadzor’s expert institutions, which generally involve a smaller volume of testing.

The expert institution evaluates the documents within three business days. Roszdravnadzor then makes a final decision within two business days.

The registration certificate is issued for a specific batch of the medical device and is valid until January 1, 2028.

Thus, for several categories of medical devices, accelerated procedures have been established to reduce time and costs and ensure rapid market access.

Challenging a Refusal of State Registration

Decisions and actions (or omissions) of the regulatory body regarding a refusal of registration may be challenged in court.

Such challenges are conducted according to the rules of Chapter 24 of the APC RF, Challenging Non-Normative Legal Acts, Decisions, and Actions (Omissions) of State Bodies. For a court to grant the petition, the applicant must collectively prove:

• the non-compliance of the challenged decision or action with the law or other legal acts;
• the violation of the applicant’s rights and legitimate interests in the sphere of entrepreneurial or other economic activity, or the illegal imposition of obligations or creation of other obstacles.

Current judicial practice shows that courts often side with the regulatory body.

For example, in Matter No. A40-172170/2018, [8] a company applied for the registration of a powder dressing. The expert institution concluded that its efficiency and clinical safety were not confirmed. Roszdravnadzor refused registration. The company challenged this in court, citing procedural violations during the expertise. However, the court ruled that the applicant failed to provide evidence of such violations. A subsequent corrected expert report was not considered, as it was not part of the formal expertise stage. The refusal was upheld.

In Matter No. A40-298764/2023, [9] registration was refused for diagnostic gloves due to a negative expert conclusion stating that the applicant failed to provide a reasoned justification for the lack of cytotoxicity studies. The court of first instance found that the applicant failed to prove the conclusion was illegal. The appellate court noted that the applicant did not request a court-appointed forensic expertise. The refusal was upheld.

In summary, despite the simplification and shortening of procedures, the medical device registration process involves many nuances. A significant number of refusals by Roszdravnadzor are due to incorrectly prepared documents. While challenging a refusal is possible, it is a complex and costly endeavor.

To minimize risks and ensure rapid market entry, we recommend engaging qualified specialists to support the state registration procedure.

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References

[1] Decree of the Government of the RF No. 2214 dated December 30, 2025, On Amending Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024, and the Application of Certain Provisions of the Rules for State Registration of Medical Devices.

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

[3] Order of the Ministry of Health of Russia No. 4n dated June 6, 2012, On Approval of the Nomenclature Classification of Medical Devices (together with the Nomenclature Classification of Medical Devices by Type and the Nomenclature Classification of Medical Devices by Class Depending on the Potential Risk of Their Use).

[4] Resolution of the Arbitration Court of the Moscow District No. F05-7663/2023 dated April 21, 2023, in Matter No. A40-126860/2022.

[5] Order of Roszdravnadzor No. 3371 dated May 6, 2019, On Approval of the Administrative Regulation of the Federal Service for Surveillance in Healthcare for the Provision of the State Service for the State Registration of Medical Devices.

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

[7] Decree of the Government of the RF No. 430 dated April 3, 2020, On the Features of the Circulation of Medical Devices, Including the State Registration of a Series (Batch) of a Medical Device.

[8] Ruling of the Supreme Court of the RF No. 305-ES19-17064 dated October 7, 2019, in Matter No. A40-172170/2018.

[9] Resolution of the Arbitration Court of the Moscow District No. F05-31237/2024 dated March 25, 2025, in Matter No. A40-298764/2023.