Authorized Representative of a Medical Device Manufacturer in Russia: Authority and Liability

July 16, 2026

BRACE Law Firm ©

An authorized representative of a manufacturer is an entity that represents the interests of a medical device manufacturer and bears responsibility regarding the circulation of the medical device within the Russian Federation, including matters related to conformity assessment and state registration procedures.

The Rules for the State Registration of Medical Devices, approved by Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024 (as amended on the date of this material preparation) (the "Rules No. 1684"), impose an obligation on foreign manufacturers to appoint an authorized representative of the manufacturer (the "Authorized Representative"), acting during the period of the medical device circulation within the Russian Federation, and to maintain the information about the representative contained in the registration dossier up to date (paragraph one of Item 29 of the Rules No. 1684).

In accordance with paragraph two of Item 29 of the Rules No. 1684 (as amended by Decree of the Government of the Russian Federation No. 1206 dated August 13, 2025),[1] the information regarding the Authorized Representative must be entered into the medical device registration dossier or updated by September 1, 2026. Effective from the same date, sub-item "e" of Item 137 of the Rules No. 1684 (Item 7 of Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024, as amended by Decree of the Government of the Russian Federation No. 1206 dated August 13, 2025) enters into force, stipulating that the absence of information regarding the appointment of an Authorized Representative in the registration dossier results in the suspension of the state registration of the medical device for 90 business days, and upon the expiration of this period, the cancellation of the state registration of the medical device.

In this article, we analyze:

Who can act as an authorized representative of a medical device manufacturer;
What requirements the legislation of the Russian Federation and the EAEU imposes on the Authorized Representative;
How to formalize the relationship with the Authorized Representative;
Which functions, powers, and liabilities the legislation imposes on such representatives.

Entities Eligible to Act as an Authorized Representative of a Medical Device Manufacturer

The authorized representative of a medical device manufacturer is a legal entity or an individual registered as a sole proprietor, acting as a resident of the Russian Federation, authorized by the medical device manufacturer to represent its interests regarding the circulation of the medical device within the Russian Federation, including matters related to conformity assessment and state registration procedures (paragraph twenty-five of Item 4 of the Rules No. 1684).

A similar definition is provided in Item 2 of the Rules for Registration and Examination of Safety, Quality, and Efficacy of Medical Devices within the EAEU, approved by Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016 (the "EAEU Rules"). However, the EAEU law definition is broader: it explicitly obligates the Authorized Representative to bear responsibility regarding the medical device circulation within the EAEU and the compliance with mandatory requirements applicable to medical devices and allows the authorization to be formalized by an agreement or another document prescribed by the legislation of the member states (Item 2 of the EAEU Rules).

Since manufacturers of medical devices have the right to choose the rules for registering medical devices (under the Russian legislation or the EAEU law) until December 31, 2027, the legal regulation of the authorized representative institution under national and supranational law is examined below. This deadline is established by Article 11 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014, as amended by the Protocol signed in Moscow on December 29, 2025. The Protocol is temporarily applied from January 9, 2026, and the draft law on its ratification has been submitted to the State Duma. The same Protocol dated December 29, 2025, extended the related transitional periods: the re-registration of previously issued national Marketing Authorizations under the EAEU rules, as well as the introduction of amendments to the registration documents of a medical device registered under national rules (if such amendments do not require a new registration), are permitted provided the respective application is submitted before December 31, 2028. This is directly relevant for updating the information regarding the Authorized Representative for nationally registered devices.

A systematic interpretation of Rules No. 1684 and the EAEU Rules reveals the following requirements for an Authorized Representative:

Residency Requirement: The legal entity or sole proprietor must be registered in the Russian Federation, or under the EAEU law, in the territory of an EAEU member state. Residency for EAEU purposes implies registration in the territory of any member state (not necessarily the Russian Federation). The Authorized Representative is not required to be located in the reference state: if the Authorized Representative is not a resident of the reference state, a copy of the document confirming its registration as a legal entity or a sole proprietor shall be additionally included in the registration dossier (Item 3 of Appendix No. 4 to the EAEU Rules).
Documentary Formalization of Authority: An agreement or another document prescribed by law. For the purpose of interacting with the regulatory authority, the power of attorney granting the right to represent the interests of the medical device manufacturer is required.
Continuity of Authority: The Authorized Representative must act throughout the entire period of the medical device circulation (Item 29 of the Rules No. 1684; Item 7 of the EAEU Rules), and the information regarding the representative must be kept up to date.

Undoubtedly, the successful execution of the representative's functions also directly depends on their professional training and expertise. Therefore, in practice, it is advisable for the Authorized Representative to meet criteria such as:

Demonstrating proven experience in the registration and circulation of medical devices;
Employing qualified personnel with knowledge of the Russian Federation and EAEU regulatory acts in the field of medical device circulation;
Establishing effective communication with regulatory bodies and possessing the ability to build relations with Roszdravnadzor and other regulators to promptly resolve issues.

Core Functions of the Authorized Representative of a Medical Device Manufacturer

The key objective of a foreign manufacturer's Authorized Representative is to ensure the lawful circulation of medical devices within the territory of the Russian Federation and the EAEU.

Based on the analysis of regulatory legal acts, the functions of the Authorized Representative can be conditionally grouped into several categories:

Managing the medical device registration process and maintaining the registration dossier up to date;
Participating in the post-marketing monitoring of the medical device safety and responding to adverse reactions;
Interacting with the regulatory authority;
Overseeing the circulation of the medical device;
Handling complaints and claims.

Naturally, the scope of the Authorized Representative's duties and tasks depends on the risk class of the device and the stage of the medical device lifecycle; regarding post-marketing monitoring, it derives from the Procedure for Monitoring the Safety of Medical Devices, approved by Order of the Ministry of Health of Russia No. 980n dated September 15, 2020,[2] and under the EAEU law, it aligns with the Rules for Monitoring the Safety, Quality, and Efficacy of Medical Devices, approved by Decision of the Board of the Eurasian Economic Commission No. 174 dated December 22, 2015.[3]

It should be noted that each medical device can only be assigned to one class:

Class 1 – medical devices with a low risk level;
Class 2a – medical devices with a medium risk level;
Class 2b – medical devices with an elevated risk level;
Class 3 – medical devices with a high-risk level.

As the class increases, the scope of obligations and requirements for the Authorized Representative also expands.

On September 1, 2026, Order of the Ministry of Health of Russia No. 980n dated September 15, 2020, becomes invalid. From this date, the procedure for monitoring the safety of medical devices (excluding those registered under the EAEU law) is governed by Order of the Ministry of Health of Russia No. 540n dated May 26, 2026, and the procedure for reporting adverse reactions is regulated by Order of the Ministry of Health of Russia No. 541n dated May 26, 2026. The timelines and obligations provided below are current as of the date of this material preparation and must be verified against the new regulations after September 1, 2026 (notably, this date coincides with the final deadline for updating the information regarding the Authorized Representative).

Order of the Ministry of Health of Russia No. 980n dated September 15, 2020, explicitly assigns a number of obligations to the Authorized Representative:

Submitting a reasoned position on the adverse reaction to Roszdravnadzor within 10 business days from the date of receipt of the notification (sub-item 2 of Item 5 of the Procedure);
Developing and submitting for approval a program of measures to prevent harm within 10 business days from the date of receiving the information (Item 8);
Revising the program within 10 business days (Item 11);
Implementing measures that preclude the escalation of harm (Item 12).

Failure to take such measures grants Roszdravnadzor the right to make a decision to withdraw the medical device from circulation (Item 14).

The specific scope of obligations must be thoroughly defined in the agreement between the manufacturer and the Authorized Representative.

Structuring the Agreement with the Authorized Representative of a Foreign Medical Device Manufacturer

An agreement must be executed in writing with the Authorized Representative. From the perspective of the Civil Code, it generally constitutes a mixed agreement (Item 3 of Article 421 of the Civil Code), combining elements of an agency agreement (Chapter 49 of the Civil Code), an agreement for the paid provision of services (Chapter 39 of the Civil Code), and a commission agency agreement (Chapter 52 of the Civil Code). The choice of the predominant contractual structure affects the applicable rules, including the right to unilateral termination of the agreement (Article 782 of the Civil Code for the paid provision of services; Article 977 of the Civil Code for an agency agreement) and the termination procedure, which is critical for ensuring the continuity of the Authorized Representative's authority.

During registration under the EAEU rules, the agreement between the manufacturer and the Authorized Representative (or a copy thereof) is explicitly included in the registration dossier (Item 3 of Appendix No. 4 to the EAEU Rules).

Given the regulatory complexity and the significance of the subject matter, the following sections must be elaborated in detail within the agreement:

1. Subject Matter and Scope of the Agreement. It is necessary to define the essence of the contractor's obligations and specify the list of medical devices for which the Authorized Representative acts (identifying them by name, model, catalog numbers, Marketing Authorization number, and potential risk class), as well as to determine the territory of validity (the Russian Federation or EAEU countries).

2. Obligations and Powers of the Authorized Representative. This is the core section of the agreement with the Authorized Representative. A standard set of powers typically includes the following:

Block 1. Registration Actions:

Drafting and filing applications for registration, introduction of amendments, suspension and resumption of validity, and termination of registration;
Coordinating the testing and studies of the medical device;
Interacting with expert organizations during the examination of the quality, safety, and efficacy of the medical device;
Maintaining the registration dossier up to date and ensuring the timely introduction of required amendments;
Receiving and archiving documentation.

Block 2. Post-Marketing Monitoring:

Organizing a system for receiving reports on adverse reactions;
Logging and conducting the initial classification of adverse reactions;
Establishing the procedure for interacting with the manufacturer, entities involved in the medical device circulation, and the regulatory authority;
Determining the process for participating in the development and implementation of corrective actions and submitting the corresponding reports to the regulatory authority.

Block 3. Interactions with the Regulatory Authority:

Representing the manufacturer's interests during Roszdravnadzor inspections (scheduled, unscheduled, documentary, and on-site);
Responding to inquiries, binding orders, and representations from the regulatory authority;
Participating in proceedings concerning administrative offenses;
Attending manufacturing inspections;
Managing the procedures for recalls, suspension of sales, and batch withdrawals;
Filing reports (regarding imported batches, destruction, etc.).

Block 4. Oversight of Medical Device Circulation in the Russian Federation and the EAEU. Monitoring compliance with applicable mandatory requirements (general safety and efficacy requirements; labeling requirements; technical and operational documentation requirements).

Block 5. Handling Complaints and Claims:

Receiving and registering complaints from consumers, healthcare organizations, and distributors;
Conducting pre-trial settlement within the limits agreed upon with the manufacturer;
Notifying the manufacturer.

3. Risk Allocation. Because the Authorized Representative assumes high public law risks for relatively modest compensation, the following mechanisms may be applied in practice to maintain a balance of interests:

(a) Insurance. The Authorized Representative may voluntarily insure its civil liability against the risk of causing harm to consumers. There are also instances of insuring the manufacturer's liability, with the Authorized Representative included in the list of insured parties.

(b) Bank Guarantee. The manufacturer may provide the Authorized Representative with an irrevocable independent (including bank) guarantee (Article 368 of the Civil Code) to cover administrative fines imposed on the Authorized Representative due to the manufacturer's fault, legal expenses incurred when subjected to civil liability, etc. The provision regarding insurance or the issuance of a guarantee should be explicitly stipulated in the agreement, as it is not mandated by law.

(c) Indemnity Clauses. Indemnity clauses are contractual provisions under which one party undertakes to compensate the other for losses or expenses if specific circumstances predefined in the agreement arise. This is a risk reallocation mechanism: the party providing such a clause commits to indemnifying the other party for losses resulting from a specific event (e.g., fines, legal expenses, or payouts for awarded amounts arising from the medical device quality, or the actions/omissions of the manufacturer, raw material and component suppliers, etc.).

This approach in Russian law is based on Article 406.1 of the Civil Code (Compensation for Losses Arising in the Event of the Occurrence of Circumstances Defined in the Agreement) and allows demanding loss compensation regardless of a breach of obligation or the manufacturer's fault. An agreement on the compensation of losses may only be concluded by parties acting in the course of their entrepreneurial activities and must be explicit and unambiguous (Items 16 and 17 of Resolution of the Plenum of the Supreme Court of the Russian Federation No. 7 dated March 24, 2016, On Application by the Courts of Certain Provisions of the Civil Code of the Russian Federation Regarding Liability for Breach of Obligations).

It is also possible to provide for a reverse indemnity: the liability of the Authorized Representative to the manufacturer for its own breaches (failure to report, delays, loss of documents, disclosure of information).

4. Liability of the Authorized Representative. In 1684 intent or gross negligence.

5. Term of the Agreement and Early Termination Procedure. Because replacing an Authorized Representative requires the formalization of authority, the transfer of documents, and the amendment of data in the registration dossier, it is advisable to stipulate a notice period in the agreement for one party to inform the other of its withdrawal from the agreement. During this period, the Authorized Representative must continue to perform all functions, while the manufacturer takes steps to transfer information and documents to the new Authorized Representative.

Thorough drafting of contractual terms allows for a significant mitigation of risks related to the improper performance of duties and the incurrence of liability.

Executing the Power of Attorney for the Authorized Representative of a Medical Device Manufacturer

The agreement between the manufacturer and the Authorized Representative governs their mutual obligations (when registering under the EAEU rules, as noted above, it is included in the registration dossier). For the purposes of interacting with third parties (the regulator, courts, customs, consumers), the document confirming the authority of the Authorized Representative is the power of attorney issued by the manufacturer to the Authorized Representative.

According to Article 185 of the Civil Code, the power of attorney is recognized as a written authorization issued by one person to another for representation before third parties. A mandatory requisite of the power of attorney is its date of execution. Additionally, the power of attorney must contain the following information:

Stating the name and registration details of the principal (the medical device manufacturer);
Specifying the name, INN/OGRN of the Authorized Representative;
Detailing information regarding the powers: if it is not specified, the document is void (Item 1 of Article 186 of the Civil Code);
Indicating the validity period;
Providing information about the signatory (full name, position). Moreover, the authority of such a person must be confirmed in accordance with the procedure established by law.

Furthermore, according to the informational message of Roszdravnadzor dated February 27, 2025,[4] the power of attorney must also contain information:

Confirming the representation of the manufacturer's interests;
Acknowledging the liability regarding the medical device circulation within the Russian Federation, including matters related to conformity assessment procedures and the state registration of the medical device;
Granting the right to certify the manufacturer's documents.

The document confirming the authority of the Authorized Representative must enter into force prior to the execution of the documents included in the registration dossier (sub-item "b" of Item 112 and sub-item "b" of Item 120 of Rules No. 1684).

The position of the regulatory authority should be considered separately: a power of attorney confirming the authority of the Authorized Representative for state registration under the previously effective Rules, approved by Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012, does not confirm the authority to perform registration actions outlined in the Rules No. 1684. Previously issued powers of attorney must be re-executed.

The power of attorney is signed by a person entitled to issue it on behalf of the manufacturer. Under Russian legislation, a power of attorney for a legal entity does not require notarization. However, a power of attorney from a foreign manufacturer must be executed in a manner that ensures its acceptance by the Russian regulatory authority. In practice, the following options are utilized:

Notarizing the power of attorney at the place of its issuance, affixing an apostille, and translating it into Russian with a notarial certification of the translator's signature (for member states of the Convention Abolishing the Requirement of Legalization for Foreign Public Documents dated October 5, 1961);
Securing consular legalization (for states not participating in the 1961 Hague Convention and not bound to the Russian Federation by an international treaty exempting documents from legalization), followed by a translation into Russian;
Relying on an exemption from legalization by virtue of an international treaty in this case, only a translation into Russian, certified in the prescribed manner, is required (bilateral legal assistance treaties, including the Treaty between the Russian Federation and the People's Republic of China on Legal Assistance in Civil and Criminal Matters dated June 19, 1992).

Delegation of authority is permitted if the Authorized Representative is authorized to do so by the power of attorney or is compelled to do so by circumstances to protect the manufacturer's interests (Item 1 of Article 187 of the Civil Code). As a rule, the power of attorney issued by way of delegation is subject to notarization; however, this rule does not apply to powers of attorney issued by way of delegation by legal entities (paragraph two of Item 3 of Article 187 of the Civil Code). The entity transferring the authority is obligated to notify the manufacturer of this within a reasonable timeframe and provide the necessary information about the new representative; failure to fulfill this obligation places the responsibility for the actions of such a person on the delegating entity as if they were its own (Item 2 of Article 187 of the Civil Code).

Although several of the requirements for the content of the power of attorney are not explicitly stipulated by Russian legislation, to prevent refusals in the acceptance and review of documents, we strongly recommend adhering to the regulator's position when issuing a power of attorney.

Updating Authorized Representative Data in the Registration Dossier

In the event of a change in the Authorized Representative's data, it will be necessary to introduce the corresponding amendments into the registration dossier and the State Register.

This is required in the following scenarios:

Addressing the reorganization of the Authorized Representative;
Modifying the name of the Authorized Representative as a legal entity (full and abbreviated (if applicable), including the corporate name), or its registered address;
Updating the surname, first name, and patronymic, the residential address of the Authorized Representative as a sole proprietor, and the details of their identity document.

Changes to the information regarding the Authorized Representative are classified as amendments that do not require an examination of safety, quality, and efficacy, but they do necessitate the introduction of corresponding amendments into the registration dossier and the State Register (sub-item "g" of Item 111 of the Rules No. 1684; under the EAEU law, sub-item "c" of Item 87 of the EAEU Rules).

The procedure for introducing amendments under the national framework is regulated by Section V of the Rules No. 1684. The step-by-step procedure is outlined as follows:

1. The manufacturer executes a new power of attorney and, if necessary, a notice of revocation for the previous one.

2. The applicant (the manufacturer or the Authorized Representative holding the relevant authority), in accordance with Item 112 of the Rules No. 1684, files an application with Roszdravnadzor no later than 90 business days from the date the relevant data changes to amend the registration dossier, attaching copies of documents confirming authority and documents that have undergone the respective changes (extracts from the Unified State Register of Legal Entities / Unified State Register of Individual Entrepreneurs, the passport details of the Authorized Representative, etc.). Documents are submitted via the applicant's unified personal account on the Unified State Health Information System in the Sphere of Healthcare.

It will also be necessary to pay the state duty to introduce the amendments. The amount of the state duty is defined by sub-item 3 of paragraph 1 of Article 333.32.2 of the Tax Code of the Russian Federation and amounts to 2,500 rubles (for the procedure under the EAEU rules, sub-item 3 of paragraph 2 of Article 333.32.2 of the Tax Code of the Russian Federation also prescribes 2,500 rubles).

3. Roszdravnadzor verifies the completeness and accuracy of the submitted information and documents. In the absence of deficiencies, the regulatory authority:

Issues an order to introduce the amendments into the registration dossier;
Sends a notification to the applicant regarding the adopted decision via the personal account;
Updates the registry entry.

The timeframe for the amendment procedure does not exceed 18 business days from the date of receipt of the application and the documents specified in Item 112 of the Rules No. 1684 (Item 113 of Rules No. 1684).

The procedure for introducing amendments under the EAEU law is governed by Sections V and VI of the EAEU Rules. Changes to the information regarding the Authorized Representative (name of the legal entity, registered address, sole proprietor data) are introduced via a notification procedure (Section VI, sub-item "c" of Item 87 of the EAEU Rules). The applicant is obligated to initiate the amendment procedure within 90 calendar days from the date such changes are made to the registration dossier documents (Item 66 of the EAEU Rules) and submits the following set of documents to the competent authority (expert organization) of the reference state:

Filing an application for amendments on paper and (or) in electronic form following the template in Appendix No. 9 to the EAEU Rules;
Providing a copy of the document confirming the authority of the Authorized Representative;
Supplying documents and details concerning the respective changes.

The procedure does not require coordination with the states concerned, and therefore, the states concerned are not listed in the application (Item 96 of the EAEU Rules).

Timeframes for executing the actions:

Verifying the completeness and accuracy of the information – 7 business days (Item 90);
Adopting the decision to initiate the procedure – 3 business days (Item 93);
Introducing the amendments – 15 business days from the date of adopting such a decision (Item 95 of the EAEU Rules).

If the amendments affect the information contained in the Marketing Authorization, a new authorization is issued while retaining the original number (Item 97 of the EAEU Rules).

The absence of up-to-date information regarding the Authorized Representative in the registration dossier constitutes an independent ground for suspending the validity of the EAEU Marketing Authorization (sub-item "c" of Item 114 of the EAEU Rules). An application for the cancellation (revocation) of the Marketing Authorization may only be filed by the Authorized Representative if an up-to-date document confirming its authority is present in the registration dossier, or if such a document is submitted alongside the application (Item 124 of the EAEU Rules).

It should be emphasized that the most significant risks arise in scenarios where the agreement with the previous Authorized Representative has already been terminated, yet a new one has not been appointed. Until amendments are introduced into the registration dossier and the registry entry, the regulatory authority relies on the information contained therein and continues interacting with the former Authorized Representative, even though the power of attorney issued to it may have already been revoked (sub-item 2 of Item 1 of Article 188, Item 1 of Article 189 of the Civil Code). Therefore, it is critical within a reasonable timeframe to:

Transfer the complete registration dossier, details of complaints, registered adverse reactions, initiated corrective actions, and correspondence with the regulator to the new Authorized Representative;
Notify Roszdravnadzor regarding the termination of authority;
Maintain the confidentiality of the manufacturer's information and refrain from using it for commercial advantage.

Distinguishing the Status of the Authorized Representative from Other Entities

Conflating roles in practice leads to an inaccurate assessment of risks. In this regard, it is essential to distinguish between:

The manufacturer, whose information is entered into the State Register and in whose name the Marketing Authorization is issued;
The Authorized Representative, who represents the manufacturer's interests and bears responsibility regarding the medical device circulation, but does not become the Marketing Authorization Holder;
The importer of medical devices;
The authorized organization (authorized sole proprietor), meaning the entity performing the functions of the manufacturer (seller) based on an agreement with it, and undertaking the acceptance and satisfaction of consumer claims regarding goods of inadequate quality.

The concepts of importer and authorized organization are defined in the preamble of Law of the Russian Federation No. 2300-I dated February 7, 1992, On the Protection of Consumer Rights (the "Consumer Protection Law"). A single entity may combine several roles, but it is precisely the actual set of roles that determines the scope of its civil liability to the consumer.

Legal Liability Landscape for the Authorized Representative of a Medical Device Manufacturer

The Authorized Representative bears a multi-layered liability that cannot be entirely excluded by an agreement with the manufacturer, as a substantial portion of it is of a public law nature.

In accordance with the legislation, the Authorized Representative may be subjected to the following types of liability:

1. Administrative Liability of the Authorized Representative.

The Code of Administrative Offenses of the Russian Federation (CAO RF) contains several offenses potentially applicable to the Authorized Representative:

Article 6.28 of the CAO RF "Violation of Established Rules in the Sphere of Circulation of Medical Devices". This is the primary (residual) offense, applied if the actions do not contain elements of a criminal offense. It covers a broad spectrum of violations, including the circulation of unregistered medical devices, violations of labeling, packaging, and operational documentation requirements, as well as the failure to fulfill safety monitoring obligations. Fines range from 2,000 to 4,000 rubles for citizens, from 5,000 to 10,000 rubles for officials, and from 30,000 to 50,000 rubles for legal entities.
Article 6.33 of the CAO RF "Circulation of Falsified, Counterfeit, Substandard and Unregistered Medicinal Products, Medical Devices and Turnover of Falsified Dietary Supplements". Regarding medical devices, Parts 1 and 2 of this article cover the production, sale, and importation of falsified medical devices, as well as the sale and importation of counterfeit and substandard medical devices; the circulation of unregistered medical devices is not covered by this offense. Fines range from 70,000 to 100,000 rubles for citizens, from 100,000 to 600,000 rubles for officials, from 100,000 to 600,000 rubles or administrative suspension of activities for up to 90 days for sole proprietors, and from 1,000,000 to 5,000,000 rubles or administrative suspension of activities for up to 90 days for legal entities.
Article 19.7 of the CAO RF "Failure to Provide Information to a State Body (Official) Exercising State Control (Supervision)". A warning or an administrative fine: from 100 to 300 rubles for citizens, from 300 to 500 rubles for officials, and from 3,000 to 5,000 rubles for legal entities.

It should be noted that significant factors influencing the size of the penalty include the nature of the device, the degree of public danger of the violation, the presence or absence of actual consequences for patients, and the readiness to rectify the violations. Furthermore, the Authorized Representative cannot evade administrative liability by claiming that the manufacturer failed to provide it with information or other materials.

For instance, in case No. A56-86911/2019,[5] Roszdravnadzor conducted an unscheduled inspection of a Company acting as the Authorized Representative for a Chinese medical instrument manufacturer to verify compliance with the rules for medical device circulation. During the inspection, a discrepancy was identified between the length of the medical instruments and the material from which they were manufactured, compared to the data specified in the registration dossier. Based on the identified violations, a protocol on an administrative offense was drawn up against the Company for the sale of substandard medical devices.

During the review of the administrative offense case, the court concluded that the Company, acting as the manufacturer's representative, failed to monitor the availability of accessible parameters of the medical device for compliance with the registration dossier. The Company was held administratively liable under Part 2 of Article 6.33 of the CAO RF, with a penalty imposed in the form of a fine amounting to 500,000 rubles, which is below the lowest threshold of the penalty for legal entities (1,000,000 rubles), as permitted by Parts 3.2 and 3.3 of Article 4.1 of the CAO RF.

2. Civil Liability of the Authorized Representative.

In accordance with Articles 1095 and 1096 of the Civil Code, harm caused to the life, health, or property of a citizen, or to the property of a legal entity as a result of design, formula, or other defects of medical devices, is subject to compensation at the discretion of the injured party by the seller or the manufacturer of the goods (Item 1 of Article 1096 of the Civil Code). Harm caused due to the failure to provide complete or accurate information about the goods is also subject to compensation.

The status of the Authorized Representative does not inherently make it a seller or a manufacturer. Tort liability under Articles 1095–1097 of the Civil Code arises for the Authorized Representative if it simultaneously acts as the seller (importer) of the medical device. Furthermore, if the Authorized Representative, based on an agreement with the manufacturer, accepts and satisfies consumer claims regarding goods of inadequate quality, it may be classified as an authorized organization within the meaning of the Consumer Protection Law, carrying all ensuing obligations (Articles 18, 22, and 23 of the Consumer Protection Law). As a general rule, a claim for compensation of harm may be filed within the established expiration date or service life of the goods, and if these are not established, within 10 years from the date of the goods' production. At the same time, harm is compensated regardless of the time it was caused if the expiration date (service life) was not established in violation of legal requirements or if the consumer was not provided with complete and accurate information about the goods (Article 1097 of the Civil Code).

Harm is compensated in full. The absence of fault on the part of the Authorized Representative does not relieve it of liability. Exemption from liability is only possible if it is proven that the harm occurred as a result of force majeure or the consumer's violation of the established rules for using or storing the goods (Article 1098 of the Civil Code).

In addition, the Consumer Protection Law grants the consumer the right to claim a penalty for a delay in satisfying demands to eliminate defects at the rate of 1% of the price of the goods for each day of delay, and a fine for failing to voluntarily satisfy the consumer's demands amounting to 50 percent of the sum awarded by the court in favor of the consumer (Item 1 of Article 23 and Item 6 of Article 13 of the Consumer Protection Law).

For example, in case No. 2-1708/2026,[6] plaintiff Ch. filed a lawsuit against Company B., the representative of a mammary implant manufacturer, demanding compensation for damages in the amount of the cost of a repeat surgery, and a fine amounting to 50% of the sum awarded by the court for the refusal of voluntary compliance.

The claims were based on the fact that the plaintiff underwent breast endoprosthesis surgery in a medical clinic. According to the documentation provided, the mammary implants carried a lifetime warranty. During a routine ultrasound examination, signs of damage to both implants were detected. The plaintiff did not violate the regimen prescribed by the attending physician and did not sustain any trauma or impacts. Company B. requested the dismissal of the lawsuit, arguing that it had forewarned the plaintiff of the need to provide the extracted implants to conduct its own investigation. A forensic examination was ordered, and according to its conclusion, manufacturing defects of the medical devices could be the potential cause of the damage to Ch.'s breast implants. The court concluded that the plaintiff was misled by the defendant regarding the necessity of sending the implants to the manufacturer after their removal; under the warranty terms, it was sufficient to send a video of the removal surgery. These circumstances evidenced the failure of the defendant to provide accurate information to the plaintiff as a consumer. The court satisfied the claim for damages amounting to the cost of the repeat surgery in full and reduced the fine for the refusal to voluntarily satisfy the demand.

The right of recourse against the manufacturer arises after the compensation of harm (Item 1 of Article 1081 of the Civil Code); however, the feasibility of recourse depends on the applicable law, the manufacturer's jurisdiction, the presence of an arbitration clause, and contractual warranties.

3. Criminal Penalties for the Authorized Representative.

The most severe violations in the field of medical device circulation may lead to criminal liability under Article 238.1 of the Criminal Code of the Russian Federation (CC RF), Circulation of Falsified, Substandard and Unregistered Medicinal Products, Medical Devices and Turnover of Falsified Dietary Supplements. The actus reus of this crime consists of:

Manufacturing, selling, or importing falsified medical devices into the territory of Russia;
Selling or importing substandard medical devices;
Unlawfully manufacturing, selling, or importing unregistered medical devices into the territory for the purpose of sale.

Liability arises if the act is committed on a large scale. A large scale is recognized as the value of medical devices exceeding 100,000 rubles. An aggravated offense (Part 2 of Article 238.1 of the CC RF) entails imprisonment for a term of 5 to 8 years with a fine ranging from 1,000,000 to 3,000,000 rubles; a highly aggravated offense (Part 3 of Article 238.1 of the CC RF – acts negligently causing the death of two or more persons) carries imprisonment for a term of 8 to 12 years with a fine ranging from 2,000,000 to 5,000,000 rubles. Note 3 to Article 238.1 of the CC RF must also be considered, as it precludes its application to certain instances of the sale and importation of unregistered medical devices.

Depending on the actions committed, qualification under other articles of the CC RF is also possible, such as Article 238 of the CC RF Manufacturing, Storing, Transporting or Selling Goods and Products, Performing Works or Providing Services Not Meeting Safety Requirements", Article 327 of the CC RF "Forgery, Manufacturing or Circulation of Forged Documents, State Awards, Stamps, Seals or Blanks, Article 201 of the CC RF "Abuse of Authority", or Article 159 of the CC RF Fraud. The offenses stipulated by Articles 292 and 293 of the CC RF are not applicable to the Authorized Representative, as they require a special subject – an official (a state or municipal employee).

The appointment of an Authorized Representative is mandatory for foreign manufacturers of medical devices. We reiterate that by September 1, 2026, the information regarding the Authorized Representative must be entered into the medical device registration dossier or updated.

The agreement with the Authorized Representative must be thoroughly elaborated, incorporating risk allocation and indemnity clauses. In addition to the agreement, the power of attorney is required for external representation. Its incompleteness or non-compliance can paralyze interaction with the regulator and create a risk of suspending the state registration.

One of the most critical functions of the Authorized Representative, apart from registration duties, is post-marketing monitoring. It is in this area that the Authorized Representative may incur maximum administrative liability, and the manufacturer may face maximum reputational damage in the event the system fails.

The continuous access to the medical device market in the territory of Russia and other EAEU countries depends on a well-established and competently regulated interaction between the medical device manufacturer and its authorized representative.

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References

Decree of the Government of the Russian Federation No. 1206 dated August 13, 2025, On Amending Decree of the Government of the Russian Federation No. 1684 Dated November 30, 2024.
Order of the Ministry of Health of Russia No. 980n dated September 15, 2020, On Approving the Procedure for Monitoring the Safety of Medical Devices, becomes invalid starting September 1, 2026, due to the entry into force of Order of the Ministry of Health of Russia No. 540n dated May 26, 2026, On Approving the Procedure for Monitoring the Safety of Medical Devices, Excluding Medical Devices Registered in Accordance with International Treaties and Acts Constituting the Law of the Eurasian Economic Union.
Decision of the Board of the Eurasian Economic Commission No. 174 dated December 22, 2015, On Approving the Rules for Monitoring the Safety, Quality, and Efficacy of Medical Devices.
Informational Message of Roszdravnadzor dated February 27, 2025. Official website of Roszdravnadzor: https://roszdravnadzor.gov.ru/medproducts/news/41292.
Resolution of the Thirteenth Arbitration Appellate Court No. 13AP-37786/2019 dated March 12, 2020, regarding case No. A56-86911/2019.
Decision of the Nikulinsky District Court of the City of Moscow dated February 27, 2026, regarding case No. 2-1708/2026.