Cancellation and Suspension of State Registration of Medical Devices: Regulation in Russia and Judicial Practice

 

February 28, 2026

BRACE Law Firm©

 

Pursuant 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", the "Law on Health Protection"), only medical devices registered in accordance with the established procedure may circulate in the Russian Federation.

However, in practice, the registration authority sometimes cancels the registration of medical devices (the "medical devices", the "MDs"). In several cases, a suspension of the state registration precedes the cancellation. The grounds and procedure for such actions depend on the procedure under which the medical device was initially registered: according to the national rules of the Russian Federation or the EAEU rules.

This article examines in detail the grounds and procedure for cancelling the registration of a medical device under the Russian national procedure, as well as the legal consequences of such actions.

Regulatory Framework for the Cancellation and Suspension of Medical Device Registration

The procedure for the cancellation and suspension of the registration of a medical device registered under the national procedure is regulated by Section VIII of Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024 (the "Registration Rules", "Decree No. 1684").

The registration authority—the Federal Service for Surveillance in Healthcare (Roszdravnadzor)—carries out these administrative procedures.

Unlike the Rules for State Registration of Medical Devices approved by Decree of the Government of Russia No. 1416 dated December 27, 2012, which were in force until March 1, 2025, Decree No. 1684 significantly expanded the list of grounds for registration cancellation and introduced the suspension of registration.

Grounds for cancellation can now be conventionally divided into two types:

• those that do not require a preliminary suspension of the state registration;
• those that require a preliminary suspension of the state registration.

Below, we analyze the procedure and grounds for these administrative procedures in detail.

Grounds for Cancellation of Registration Without Preliminary Suspension of Registration

In accordance with Clause 137 of Decree No. 1684, Roszdravnadzor shall decide to cancel the state registration of a medical device without a preliminary suspension of registration in the following cases:

1. The applicant submits an application for the cancellation of the state registration.

As a general rule, the manufacturer of the medical device submits the application for cancellation. An authorized representative of the manufacturer may submit such an application only if the following conditions are simultaneously met:

• the registration dossier of the MD contains a document confirming the powers of the authorized representative of the manufacturer to represent the manufacturer’s interests;
• the application is accompanied by a letter from the manufacturer confirming its intention to cancel the state registration.

An application for cancellation of registration must include the following information:

• full and abbreviated name of the manufacturer, Taxpayer Identification Number (INN), registered office address; for an individual entrepreneur—full name, identity document details, INN, residential address, telephone number, and email address;
• similar information regarding the authorized representative of the manufacturer;
• name of the medical device (specifying the MD models (brands), their composition, and accessories);
• date of state registration of the medical device and its registration number;
• information on the reasons for submitting the application to cancel the state registration of the MD;
• information on the applicant's liability for the accuracy and identity of the submitted information.

If the applicant submits an application in violation of these requirements, the registration authority shall, within seven business days, decide to terminate further consideration of said application, providing a reasoned justification for the reasons for such a decision.

2. A court issues a ruling on the violation of the right holder’s rights to the results of intellectual activity and equivalent means of individualization of medical devices (or their models (brands)). Note that Roszdravnadzor can apply this clause only pursuant to a court decision.

3. Roszdravnadzor receives information, as a result of its state control (surveillance) over the circulation of medical devices, confirming facts and circumstances that create a threat to the life and health of citizens and medical workers when using medical devices.

For instance, in Case No. A40-41621/2024,[1] Roszdravnadzor issued a Registration Certificate to a Company for the medical device "Non-sterile nitrile medical diagnostic (examination) gloves". The registration followed a simplified procedure, which subsequently required the submission of documents for an expert evaluation of quality, efficiency, and safety. Based on the analysis of the submitted documents, the registration authority notified the applicant of the need to amend the technical documentation regarding the name of the MD, the packaging description, and the labeling. The documents received from the applicant in response to the request were sent to an expert organization. The expert organization issued a negative opinion, which served as the basis for cancelling the registration. The Company filed a petition with the court to challenge the expert opinion and the order to cancel the state registration of the medical device.

During the court hearing, it was established that the negative opinion resulted from the Company's failure to address the comments. Specifically, the labeling of the medical device contained insufficient information for the safe intended use of the device, the instructions for use were missing, and no information was provided on the method of disposal of the MD. The court concluded that the quality, efficiency, and safety of the medical device were not confirmed, and there was a risk of harm to the health of citizens and medical workers due to the use of the medical device. Consequently, the court recognized the decision to cancel the registration as legal and justified.

4. The registration authority identifies, as a result of state control (surveillance) over the circulation of medical devices, inaccurate information in the documents contained in the registration dossier that influenced the results of the expert evaluation of the quality, efficiency, and safety of the medical device.

This usually refers to cases where the manufacturer has modified the device, replaced materials, etc., but has not made corresponding changes to the registration dossier.

5. The registration authority identifies the fact of making changes to the registration dossier for software using artificial intelligence technologies for reasons not provided for by Clause 135 of Decree No. 1684.

We should clarify that said clause provides a simplified procedure for making changes to the version numbering of software using artificial intelligence technologies registered as a medical device (if they do not affect the functional purpose), provided there is a built-in function for the automatic transfer of data on its operation to Roszdravnadzor. Changes to the registration dossier for other reasons not specified in Clause 135 of Decree No. 1684 are made in accordance with the general procedure.

6. The registration authority identifies inaccurate information in the documents submitted by the applicant within the framework of the state registration procedure for the medical device.

7. A previously registered medical device is classified among the medical devices provided for by Clause 5 of Part 5 of Article 38 of the Law No. 323-FZ.

As a reminder, in accordance with the specified norm, medical devices representing kits, sets, packs, and first-aid kits consisting of registered medical devices (except for medical devices connected to a power source or equipped with a power source) and (or) medicinal products combined in a common package, provided that the secondary or primary (in the absence of secondary) packaging of the devices included in said sets is preserved, and provided that its labeling is preserved, are not subject to registration in the territory of the Russian Federation.

If any of the above cases occur, the registration authority shall, within seven business days:

• decide to cancel the state registration of the medical device;
• enter a record of the cancellation of the state registration into the state register;
• inform the applicant of the cancellation of the state registration of the medical device through the applicant's personal account.

If the state registration of a medical device is cancelled, it is impossible to resume it, except in cases where such a decision is declared invalid by a court. A new registration will be required.

Grounds for Cancellation of Medical Device Registration with Preliminary Suspension of Registration

In addition to the unconditional grounds for cancelling the registration of an MD, Clause 137 of Decree No. 1684 provides for grounds that assume a preliminary suspension of registration prior to cancellation. These include:

1. The registration authority receives an opinion from an expert institution stating that the devices contained in the state register, due to their functional purpose and (or) principle of operation, cannot be used for medical purposes and (or) are not medical devices.

The expert institution prepares such an opinion based on a corresponding assignment from the registration authority within ten business days of its receipt.

If the opinion states that the device can be used for medical purposes after making changes to the registration dossier, or if such a decision applies to some but not all registered models (brands), the registration authority shall:

• decide to suspend the state registration of the medical device for 180 business days;
• notify the applicant through the personal account on the Gosuslugi portal of the need to make changes to the documents contained in the registration dossier within the specified period.

Thus, in Case No. A40-206108/22-121-1174,[2] a Company had registered the medical device "Polymer device with a polymer brush for storage and application of solutions to the skin". After some time, Roszdravnadzor sent the documents for the aforementioned device to an expert institution for an evaluation. Based on the results of the evaluation, an opinion was received that this device is not a medical device, as its functional purpose is realized through a pharmacological effect on the human body and it is not subject to the provisions of the legislation in the sphere of circulation of medical devices. Based on the expert opinion, the registration was cancelled. This circumstance served as the reason for filing a claim with the court to recognize the decision as illegal. The court did not identify any violations in the procedural aspects of these actions. As a result, the court recognized Roszdravnadzor's decision to cancel the registration as legal.

Upon receipt of an expert opinion on the impossibility of using the device for medical purposes in full, the registration is cancelled without the suspension procedure.

2. Failure to make changes to the registration dossier confirming the powers of the authorized representative of the manufacturer regarding the circulation of the medical device in the territory of the Russian Federation.

We should clarify that Clause 29 of Decree No. 1684 established an obligation for a foreign manufacturer to appoint an authorized representative of the manufacturer in the territory of the Russian Federation by September 1, 2026, or to update information about them (if such information is present in the registration dossier) by submitting an application to change the registration dossier. Thus, this ground will start "working" after the specified date.

Prior to deciding to cancel the registration of an MD, the registration authority must:

• suspend the registration for 90 business days;
• notify the applicant of the need to update the information through the personal account on the Gosuslugi portal;
• notify all participants in the sphere of circulation of medical devices of the suspension of registration by means of an information letter on the Internet.

3. The absence in the Register of Certificates of Conformity with the requirements for the implementation, maintenance, and evaluation of the medical device quality management system of information on a periodic (planned) inspection—with respect to medical devices that have passed an initial production inspection.

As a reminder, a production inspection is an evaluation of the production conditions and the quality management system of the medical device manufacturer. It is mandatory for medical devices of potential risk class 2a, manufactured in sterile form, medical devices of class 2b, and class 3.

The rules for conducting inspections are regulated by Decree of the Government of the Russian Federation No. 135 dated February 9, 2022.[3] According to Clause 31 of said Rules, a periodic (planned) production inspection for such MDs is conducted once every five years from the date of issue of the report on the results of the initial inspection. Based on its results, the inspecting organization places the corresponding information on its conduct in the Register of Certificates, which is available on the Internet.

Prior to deciding to cancel the state registration, the registration authority shall:

• decide to suspend the registration for 180 business days from the date of expiry of the report or from the date of issuance of a negative opinion based on the results of the inspection;
• notify all participants in the sphere of circulation of medical devices of this by means of an information letter on the Internet, and the applicant—through the personal account.

4. Failure to submit a report on the clinical monitoring of a medical device to the registration authority in accordance with the procedure for reporting by entities involved in the circulation of medical devices of all cases of identification of adverse reactions.

The procedure for submitting such a report is regulated by Order of the Ministry of Health of Russia No. 1113n dated October 19, 2020.[4] It obliges manufacturers (authorized representatives) of class 3 risk medical devices, as well as implantable devices with potential risk class 2b, to monitor safety and clinical efficiency after the registration of the device. Based on the results of this monitoring, the manufacturer or authorized representative is obliged to submit clinical monitoring reports to Roszdravnadzor annually for three years, no later than February 1, starting from the year following the year of registration.

Prior to deciding to cancel the registration, the registration is suspended for 30 business days, and the applicant and participants in the sphere of circulation of medical devices are notified in the manner discussed above.

Thus, a feature of the above-considered grounds for cancellation of registration is the mandatory suspension of the registration of the medical device to eliminate the identified deficiencies. If these reasons are not eliminated within the specified timeframes, the state registration is cancelled. The cancellation of registration is carried out in the manner discussed above.

Cancellation of Registration of Medical Devices with a Risk of Shortage

In addition to the above grounds, the legislation provides for special grounds for cancelling the registration of medical devices that were registered in a simplified manner due to the risk of their shortage in accordance with Decree of the Government of Russia No. 552 dated April 1, 2022 (the "Decree No. 552"). More details on which medical devices are classified as such can be found in our special article on this topic.[6]

In accordance with Clause 7 of Decree No. 552, the registration authority shall decide to cancel the state registration of a medical device in cases where inaccurate information is identified in the documents and materials submitted to the interdepartmental commission for the purpose of including the medical device in the list of MDs for which a risk of shortage has been established.

At the same time, the cancellation of the state registration of a foreign-made medical device based on an application from the manufacturer or its authorized representative is not permitted for such medical devices.

Regarding medical devices with a low potential risk and a risk of shortage (except for medical devices manufactured in sterile form), Clause 29 of Decree No. 552 also establishes a number of special grounds for cancellation:

• an opinion from an expert institution based on the results of an evaluation, indicating that:
  • the quality, efficiency, or safety of the medical device is not confirmed by the data obtained;
  • the risk of harm to the health of citizens and medical workers due to use exceeds its efficiency;
  • the medical device does not comply with the requirements of the regulatory documentation, or the manufacturer's technical and (or) operational documentation;
• the registration authority identifies, as a result of state control over the circulation of medical devices, a discrepancy between the data on the efficiency and safety of the medical device and the data from the registration dossier;
• failure by the manufacturer or authorized representative to submit an application for state registration and a set of documents within a period not exceeding 150 business days from the date of state registration;
• receipt of information on the establishment of facts and circumstances creating a threat to the life and health of citizens and medical workers during the use and operation of the medical device;
• failure to submit samples of the medical device after registration for technical testing, toxicological studies, and testing for the purpose of type approval of measuring instruments;
• the registration authority decides to terminate consideration of the application for state registration of the medical device;
• the registration authority identifies inaccurate information in the documents submitted by the applicant for registration.

Thus, the specified special grounds for cancelling the registration of medical devices with a risk of shortage are related to the specifics of their registration, which is conducted in an accelerated and simplified manner and requires the applicant to perform certain procedures after it is conducted.

Consequences of Registration Cancellation for Entities Involved in MD Circulation

Cancellation of registration means for the manufacturer the impossibility of producing and releasing the product into circulation as a medical device. However, other entities involved in the circulation of MDs—suppliers and medical organizations—face no fewer difficulties. They have a completely logical question: what to do if the MD was purchased before its registration was cancelled?

In accordance with Part 3.1 of Article 38 of the Law on Health Protection, upon the expiry of the Registration Certificate for a medical device, the transportation, installation, assembly, adjustment, calibration of the medical device, and other actions necessary to commission the medical device, use, operation, maintenance, and repair of the medical device are permitted if provided for by the manufacturer's regulatory, technical, and (or) operational documentation, provided that its service life (shelf life) has not expired.

As we can see, the realization (sale) of medical devices is absent among such actions. Regarding the realization of medical devices, according to the position of Roszdravnadzor set out in Letter No. 1066620/22 dated October 17, 2022, the realization of medical devices is unacceptable upon the expiry of the registration period.

At the same time, judicial practice on this issue is quite contradictory. Let us illustrate this with examples from judicial practice.

Thus, in Case No. A55-3723/2023,[7] a state contract was concluded between an Institution and a Company, under which the Company undertook to supply coveralls for the protection of medical personnel. The supplier transferred the goods in the volume agreed by the parties, and the customer accepted and paid for the goods. Upon delivery of the goods, the Company provided a copy of the Registration Certificate for the goods. A few months later, information was posted on the Roszdravnadzor website regarding the cancellation of the Registration Certificate. The Institution sent a claim to the Company demanding a refund and the removal of the low-quality goods for their subsequent destruction. Due to the failure to receive a response to the claim, the Institution filed a lawsuit in court.

During the court proceedings, it was established that the cancellation of the Registration Certificate resulted from the lack of testing of the medical devices. In connection with these circumstances, Roszdravnadzor recognized the device as substandard and posing a threat of harm to the health of citizens, and issued an information letter demanding that entities involved in the circulation of medical devices prevent its circulation. The court concluded that medical devices may only be used if the Registration Certificate for that medical device has expired. However, in the case under consideration, the registration was cancelled due to the failure to submit documents confirming the safety of using the medical devices. The Institution's claim was satisfied in full.

In another Case No. A09-10792/2024,[8] an Individual Entrepreneur concluded a contract with an Institution for the supply of a medical oxygen station and its commissioning. When performing the contract, the Entrepreneur delayed delivery by more than seven months. Upon acceptance of the goods, the Customer established that one month prior to the delivery, the registration of this station as a medical device had been cancelled. In connection with the identified circumstances, acceptance and payment were refused, and subsequently, a decision was made to unilaterally terminate the contract. This circumstance served as the reason for the Entrepreneur to file a claim with the court to recognize the unilateral termination as invalid.

In justification of the unilateral termination, the Customer cited the impossibility of the medical institution using the specified equipment as technological rather than medical, in accordance with the intended purposes of its use. According to the clarifications of Roszdravnadzor requested by the court, "the cancellation of registration is not related to the quality, efficiency, and safety of the equipment's operation, but is caused by the planned work of the authorized body to update the information contained in the state register of medical devices. At the same time, the use of such devices in a medical organization is possible without a Registration Certificate...". Taking into account the position of the supervisory authority, the court concluded that the cancellation of registration only means a ban on the entry of such devices into civil circulation (production or import into Russia), but does not prohibit their realization and use if they were manufactured and purchased during the period of validity of the Registration Certificate. Based on the results of the consideration of the case, the court recognized the Institution's decision on the unilateral termination of the contract as invalid.

In Case No. A55-3722/2023,[9] the cancellation of registration was also related to the failure to conduct quality and safety tests of the MDs. However, the court agreed with the arguments of the defendant, who pointed out that the need for testing had ceased due to the end of the pandemic and the lack of demand for the products supplied under the contract. The court concluded that this does not indicate the supply of substandard goods to the plaintiff.

The literature expresses the opinion that in order to refuse acceptance of MDs with a cancelled registration, the customer needs to establish not only the fact of cancellation but also the ground for such cancellation, and often to prove the low quality of the transferred medical device.[10]

In conclusion, we note that the Registration Rules, in comparison with the previously existing legal regulation, have significantly expanded the list of grounds for cancelling registration and have introduced the procedure for suspending state registration at the level of a government act. At the same time, the list of grounds is very diverse and contains grounds related both to violations of the quality of the medical device and to non-compliance with procedural moments.

This circumstance gives rise to disputes between the manufacturer and the registration authority, as well as with entities involved in the circulation of medical devices. To avoid negative consequences, we recommend that manufacturers (their authorized representatives) extremely carefully monitor the performance of the duties imposed on them by legislation in the sphere of circulation of medical devices and timely initiate the necessary procedures.

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References

[1] By the Ruling of the Supreme Court of the Russian Federation dated May 6, 2025, No. 305-ES25-3257, the transfer of Case No. A40-41621/2024 was denied.

[2] Resolution of the Arbitration Court of the Moscow District dated September 11, 2023, No. F05-21478/2023 in Case No. A40-206108/22-121-1174.

[3] Decree of the Government of Russia No. 135 dated February 9, 2022, On Approval of the Rules for Organizing and Conducting Inspections of Medical Device Production for Compliance with the Requirements for the Implementation, Maintenance, and Evaluation of the Medical Device Quality Management System Depending on the Potential Risk of Their Use.

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

[5] Decree of the Government of Russia 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 Their Shortage or Risk of Shortage in Connection with the Introduction of Economic Restrictive Measures Against the Russian Federation.

[6] See: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/registraciya-mi-pravila-rf.

[7] Resolution of the Arbitration Court of the Volga District dated September 18, 2024, in Case No. A55-3723/2023.

[8] Resolution of the Twentieth Arbitration Appellate Court dated October 22, 2025, No. 20AP-3692/2025 in Case No. A09-10792/2024.

[9] Resolution of the Arbitration Court of the Volga District dated June 27, 2024, in Case No. A55-3722/2023.

[10] Aleksandrov G.A., Application of Legislation on the Circulation of Medical Devices in Procurement: A Review of Law Enforcement Practice // PROGOSZAKAZ.RF, 2024, No. 7.