Contract Manufacturing of Medical Devices: Regulatory Framework, Agreements, and Liability

July 4, 2026

BRACE Law Firm ©

Manufacturing medical devices is one of the most heavily regulated spheres of economic activity in the Russian Federation. This stems from the direct impact of medical devices on citizens' lives and health, which triggers stringent requirements for the quality, safety, and efficacy of the manufactured products. The law imposes a comprehensive set of obligations on medical device manufacturers: from implementing a Quality Management System to post-marketing monitoring, and from ensuring component traceability to participating in the safety monitoring system.

In this article, we examine:

the requirements imposed on a contract manufacturer of medical devices and its obligations;
the legal framework and models of contract manufacturing;
the specific features of a medical device contract manufacturing agreement;
the types and grounds of manufacturer liability;
the current litigation landscape illustrating the application of the law in this area.

Statutory and Regulatory Framework for Medical Device Manufacturing

We note that the regulation of medical device manufacturing in the Russian Federation occurs at two levels: (1) national and (2) supranational under EAEU law. Until the expiration of the transition period (until December 31, 2027), manufacturers may choose the rules under which to register and circulate medical devices, which dictates the applicable set of regulations. Furthermore, the Protocol dated December 29, 2025, amending the Agreement dated December 23, 2014, extended the transition period: submitting applications for the registration (expert review) of a medical device under EAEU rules or under the legislation of a Member State is permitted until December 31, 2027, whereas the re-registration of previously issued national Registration Certificates under Union rules and the amendment thereof are possible until December 31, 2028. Accordingly, the validity period of the State Registration Rules, approved by Resolution No. 1684, has been extended until December 31, 2028 (Resolution of the Government of Russia No. 2214 dated December 30, 2025).

Under Russian legislation, the primary regulatory acts governing the medical device manufacturing process include:

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");
Rules for the State Registration of Medical Devices, approved by Resolution of the Government of the Russian Federation No. 1684 dated November 30, 2024 (the "Resolution No. 1684");
Rules for Organizing and Conducting Inspections of Medical Device Manufacturing for Compliance with the Requirements for Implementing, Maintaining, and Evaluating a Medical Device Quality Management System Depending on the Potential Risk of Their Use, approved by Resolution of the Government of the Russian Federation No. 135 dated February 9, 2022 (the "Resolution No. 135");
Resolution of the Government of Russia No. 136 dated February 9, 2022, On Approving the Requirements for Implementing, Maintaining, and Evaluating a Medical Device Quality Management System Depending on the Potential Risk of Their Use (the "Resolution No. 136");
Procedure for Monitoring the Safety of Medical Devices, approved by Order of the Ministry of Health of Russia No. 980n dated September 15, 2020 (the "Order No. 980n");
Documents of the national standardization system: GOST ISO 13485-2017 "Medical devices. Quality management systems. Requirements for regulatory purposes", GOST ISO 14971-2021 "Medical devices. Application of risk management to medical devices", GOST R ISO 14155-2022 "Medical devices. Good clinical practice", and others. GOSTs are documents of voluntary application by virtue of Federal Law No. 162-FZ dated June 29, 2015, On Standardization in the Russian Federation, but in practice, compliance with them is necessary for subsequent registration.

At the supranational level, medical device manufacturing is regulated by:

Agreement on Common Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union dated December 23, 2014;
Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016, On the Rules for Registration and Examination of Safety, Quality, and Efficacy of Medical Devices (the "EEC Decision No. 46");
Decision of the Council of the EEC No. 27 dated February 12, 2016, On Approving the General Requirements for the Safety and Efficacy of Medical Devices, Requirements for Their Labeling and Operational Documentation For Them (the "EEC Decision No. 27");
Decision of the Council of the EEC No. 106 dated November 10, 2017, On the Requirements for Implementing, Maintaining, and Evaluating a Medical Device Quality Management System Depending on the Potential Risk of Their Use (the "EEC Decision No. 106");
Decision of the Board of the EEC No. 174 dated December 22, 2015, On Approving the Rules for Monitoring the Safety, Quality, and Efficacy of Medical Devices (the "EEC Decision No. 174").

Despite differences in document formats and procedures, both regulatory systems substantively rely on unified international approaches (ISO series standards), which ensures the methodological convergence of the national and Union regimes. Below, we examine the requirements for medical device manufacturing in detail.

Requirements for the Medical Device Manufacturer and Its Obligations

Manufacturer of a medical device – a legal entity or an individual registered as an individual entrepreneur responsible for the design and manufacture of a medical device, making it available for use on their own behalf, regardless of whether the medical device is designed and (or) manufactured by this entity or on its behalf by another entity (entities), and bearing responsibility for the safety, quality, and efficacy of the medical device (paragraph 12 of clause 4 of Resolution No. 1684).

A similar definition of this term is enshrined in EEC Decision No. 46.

This definition is of fundamental importance because it establishes the following premise: even if the actual production is outsourced to a contract manufacturer, the legal manufacturer and the bearer of the primary burden of liability remains the entity under whose name the device enters the market.

An analysis of the entire body of regulations shows that the following core requirements apply to the manufacturer:

1. Legal Capacity. The manufacturer must be registered as a legal entity or an individual entrepreneur in accordance with the legislation of the Russian Federation or another EAEU Member State. For foreign manufacturers intending to release their products into civil circulation on the market of the Russian Federation or the EAEU, it is mandatory to have an authorized representative – a Russian legal entity or individual entrepreneur (or a corresponding entity in an EAEU Member State). The authorized representative acts as the applicant during registration, the Marketing Authorization Holder, and the contact person for regulatory authorities, and bears responsibility for the circulation of the products within the relevant state to the extent prescribed by applicable regulations. The authority of the authorized representative must be formalized by a written agreement, notarized, and legalized in the prescribed manner.

2. Production Facilities and Qualified Personnel. Production facilities must comply with sanitary and epidemiological requirements, equipment must undergo validation, and personnel must possess confirmed qualifications.

3. Implementation of a Quality Management System (QMS). In accordance with Resolution No. 136 and EEC Decision No. 106, the manufacturer must implement, maintain, and evaluate a Quality Management System that complies with the requirements of GOST ISO 13485-2017. The QMS must cover all stages of the device's lifecycle: design, development, production, quality control, packaging, labeling, storage, delivery, and post-sales service.

4. Passing a Production Inspection. To verify the compliance of the actually implemented QMS with the documented framework, manufacturers of medical devices in potential risk classes 2a, 2b, and 3 (with some exceptions) must undergo a pharmaceutical inspection. The inspection is conducted by Roszdravnadzor or organizations authorized by it.

The nomenclature classification of medical devices under Russian legislation is governed by Order of the Ministry of Health of Russia No. 4n dated June 6, 2012, and for the EAEU procedure, by the Classification Rules approved by Decision of the Board of the EEC No. 173 dated December 22, 2015. The risk class predetermines the scope of the registration dossier, testing requirements, and production inspection criteria. More details regarding the production inspection procedure can be found in our dedicated article on this topic.[1]

5. Licensing. As a general rule, medical device manufacturing is not included in the list of activities subject to licensing in the Russian Federation. However, in certain instances, obtaining a license for related activities may be required. For example, for the maintenance of medical devices in accordance with Resolution of the Government of the Russian Federation No. 2129 dated November 30, 2021, or for activities involving the use of ionizing radiation sources in accordance with Resolution of the Government of the Russian Federation No. 45 dated January 25, 2022.

Obligations of Medical Device Manufacturers

Let us highlight the manufacturer's primary obligations across all stages of the medical device's lifecycle.

1. At the Design and Manufacturing Stage:

Ensuring the device complies with the safety and efficacy requirements established by technical regulations, GOSTs, and other regulatory documentation;
Conducting risk analysis in accordance with GOST ISO 14971-2021 at all stages of the device's lifecycle;
Drafting technical and operational documentation governing the manufacturing, storage, transportation, installation, setup, application, operation, maintenance, repair, disposal, or destruction of the medical device;
Executing technical testing, toxicological studies, and clinical trials regarding quality, safety, and efficacy (the procedure for which, for state registration purposes, is established by Order No. 885n dated August 30, 2021, and effective September 1, 2026, by Order of the Ministry of Health of Russia No. 421n dated May 13, 2026);
Safeguarding the traceability of raw materials, supplies, and components;
Validating production processes to ensure the stable quality of the manufactured products.

2. At the Circulation Stage:

Providing packaging and labeling that protects the device from damage and ensures its properties are preserved throughout its shelf life;
Navigating regulatory requirements for the mandatory identification labeling system (the "Chestny ZNAK") for specific categories of medical devices in accordance with the Resolutions of the Government of Russia;
Updating the registration dossier when implementing changes to the design, materials, manufacturing technology, scope of application, etc.;
Conducting post-marketing safety monitoring of the medical device in accordance with Order of the Ministry of Health of Russia No. 980n and EEC Decision No. 174.

The manufacturer must collect information from medical organizations regarding identified adverse events and verify the accuracy and completeness of such information. Based on the review of the received data, the manufacturer submits the following reports to Roszdravnadzor:

An initial report on the adverse event;
A report on corrective actions.

Under the EAEU registration rules, the initial incident report is submitted within the following timeframes (paragraph 6 of the Rules for Monitoring the Safety, Quality, and Efficacy of Medical Devices, approved by EEC Decision No. 174):

Within 2 calendar days in the event of a serious threat to health;
Within 10 calendar days in the event of death or an unforeseen serious deterioration in the user's state of health;
Within 30 calendar days in other cases.

Furthermore, obligations are imposed on the manufacturer to implement safety corrective actions, including market recalls, user notifications, and device modifications.

Regarding high-risk class 3 medical devices and implantable class 2b medical devices, clinical monitoring is additionally performed. Its essence is that for 3 years following the registration of the medical device, the manufacturer must collect information on its safety and clinical efficacy.

This mechanism (post-marketing clinical monitoring) is established by paragraph 19 of the Rules approved by EEC Decision No. 174 and applies within the framework of registration under EAEU rules: reports are submitted to the authorized body of the Reference state annually, no later than February 1, starting from the year following the year of obtaining the Registration Certificate, for a period of 3 years.

More details on the manufacturer's actions within the framework of post-marketing monitoring can be found in our dedicated article on this topic.[2]

Thus, across all stages of a medical device's civil circulation, a robust spectrum of obligations is imposed on the manufacturer.

Contract Manufacturing of Medical Devices: Legal Framework

Contract manufacturing is a production organization model where one entity (the legal manufacturer) engages another entity (the contract manufacturer) to perform all or part of the medical device production cycle. Russian legislation does not explicitly use the term "contract manufacturing" in relation to medical devices; however, it is widely utilized in the modern medical industry.

At the same time, certain elements of contract manufacturing are indirectly regulated. Specifically, in the definition of a manufacturing site (paragraph 4 of the State Registration Rules approved by Resolution No. 1684), the stages of the production process explicitly include "manufacturing of the entire medical device or its main components under agreements with a third-party manufacturer (contractor)" (except for components that are independently registered medical devices), as well as the sterilization and labeling of the device. Consequently, the contract manufacturer's facility is recognized as part of the production process and is subject to inclusion in the registration dossier and inspection on par with the legal manufacturer's facility.

The contract manufacturing framework is utilized in the following scenarios:

When the developer lacks its own manufacturing facilities;
To optimize costs, when in-house manufacturing is capital-intensive, especially for sterile devices and Advanced Therapy Medicinal Products (ATMP);
To localize the production of foreign devices in Russia to access government procurement preferences and reduce logistics costs;
For the viability of technological specialization, when it is economically sound to outsource specific operations to specialized entities.

Models of Medical Device Contract Manufacturing

In the contract manufacturing of medical devices, several models can be broadly distinguished. They differ based on how deeply the contractor is involved in the process and what role the customer assumes. These include:

Full-Cycle Model: The contractor handles the entire scope of work, from analyzing the technical specifications and drafting design documentation to mass production.
Partial-Cycle Model: The contractor specializes in specific stages, such as only assembly, or only labeling, or only sterilization. The customer retains control over other stages and may engage other partners for related tasks.

The following contract manufacturing models are also identified:

OEM (Original Equipment Manufacturer): The customer provides the manufacturer with the documentation for the medical device. The manufacturer solely handles physical production (assembly, molding, component mounting, testing, etc.).
ODM (Original Design Manufacturer): In this model, the customer provides a unique idea, design, or device concept. The manufacturer does not merely produce the finished device but participates in its development: creating a 3D model, developing technical documentation, and designing components.

Legal and Contract Manufacturer of Medical Devices

The key aspect of organizing contract manufacturing is the allocation of functions and responsibilities between two entities: (a) the legal manufacturer, acting simultaneously as the customer, and (b) the contract manufacturer. Undoubtedly, they may vary depending on the chosen manufacturing model. However, there are common characteristics.

The legal manufacturer acts as the applicant during state registration, the Marketing Authorization Holder, and its name is indicated on the medical device. It bears responsibility for the quality, safety, and efficacy of the device.

In accordance with paragraph 4.1.5 of GOST ISO 13485-2017, an organization that outsources processes affecting product conformity to third parties must ensure control over such processes. This means that the legal manufacturer's QMS must cover contract manufacturing processes, including quality monitoring, contractor audits, and control of incoming and outgoing materials.

The contract manufacturer of medical devices is responsible to the legal manufacturer for the quality and timeliness of the work performed, as well as strict adherence to manufacturing technologies.

Furthermore, the actual production site of the contract manufacturer is specified in the registration dossier and is subject to inspection. The contract manufacturer must maintain production records in a format that ensures the traceability of each batch of devices and must transfer them to the legal manufacturer within the timeframes stipulated by the agreement. Crucially, the contract manufacturer has no independent standing before Roszdravnadzor. All inquiries, audits, and sanctions are directed to the legal manufacturer.

In this regard, a change in the contract manufacturer or its manufacturing site specified in the registration dossier necessitates amending the registration dossier in the prescribed manner (and in the event of a change affecting the safety, quality, or efficacy of the device, the possibility of an expert review and (or) inspection).

Practice demonstrates that the most frequently arising potential pitfalls in relations with a contract manufacturer are the following:

Unauthorized changes to the technology or replacement of components by the contract manufacturer, leading to the risk of registration revocation and liability to third parties;
Conflicts of interest, when the contract manufacturer concurrently manufactures similar products for the customer's competitors;
Leaks of design and technological documentation, or other data constituting a commercial secret.

To mitigate these risks, we recommend that the legal manufacturer implement a set of organizational, technical, and legal measures, such as:

Conducting regular audits and quality control of processes and manufactured products;
Implementing a commercial secret regime, restricting the circle of the contract manufacturer's employees with access to it, and employing technical protective measures;
Drafting and negotiating the terms of the medical device manufacturing agreement in detail.

Below we review the essential provisions that must be included in such an agreement.

Medical Device Contract Manufacturing Agreement

By its legal nature, a medical device contract manufacturing agreement is a mixed contract combining elements of:

A contractor agreement (Chapter 37 of the Civil Code) – regarding the performance of work to manufacture devices with the transfer of the result to the customer;
An agreement for the performance of research, development, and technological work (Chapter 38 of the Civil Code) – if there are elements of Research and Development (R&D) or adaptation of the device;
An agreement for the paid provision of services (Chapter 39 of the Civil Code) – regarding services ancillary to manufacturing (storage, packaging, logistics);
A license agreement (Chapter 69 of the Civil Code) – regarding the grant of rights to use the results of intellectual activity (technical documentation, know-how, trademarks).

Depending on the cooperation model, the emphasis may shift in favor of one element or another.

Given the regulatory complexity and significance of the subject matter, the following sections must be detailed in the medical device contract manufacturing agreement:

1. Subject Matter and Object of the Agreement:

The name of the medical device, registration data (if any), potential risk class, and type of device;
The list of manufacturing operations outsourced to the contract manufacturer (full cycle, individual operations, assembly, packaging, sterilization, etc.);
Quality requirements and applicable regulatory documents;
Production volumes and the procedure for approving orders.

2. Technical Documentation and Intellectual Property:

The scope of the transferred technical, design, and technological documentation;
Exclusive Rights to the results of intellectual activity (typically retained by the customer, although variations exist where the manufacturer retains some rights);
Conditions for using the customer's trademarks on the devices and packaging;
The legal ownership of improvements developed during the execution of the agreement;
The commercial secret regime regarding the documentation transferred to the contract manufacturer.

3. Product Quality and Quality Management System: This section should specify:

The contract manufacturer's obligation to maintain a certified QMS;
The strict prohibition against altering manufacturing technology, materials, components, or control methods without the customer's written approval;
The procedure for the customer to conduct audits;
The requirements for providing assistance during inspections of the manufacturing sites.

4. Requirements for Raw Materials, Supplies, and Components:

The allocation of responsibility for purchasing raw materials and components (the customer or the contract manufacturer);
Stringent requirements for raw material suppliers;
The procedure for incoming material control;
Storage conditions for raw materials and the disposal procedure.

5. Requirements for Manufacturing Processes:

Technical specifications for the technological process, specifying control points;
Requirements for packaging and labeling;
The procedure for assigning serial numbers and batches.

6. Quality Control Procedure and Acceptance:

Control methodologies and standards;
The procedural framework for the customer's acceptance of finished products;
The mechanisms for filing claims regarding quality and quantity;
The protocols for handling products that fail quality control.

7. Price, Payment Procedure, and Cost Allocation:

The unit price of the product and its formation procedure;
The payment structure (prepayment, milestone payments, upon acceptance);
The allocation of costs for raw materials, packaging, sterilization, and logistics;
Conditions for price revision in the event of market fluctuations.

8. Delivery Timeframes and Procedure:

Timeframes for manufacturing a batch after receiving an order;
Commercial delivery terms;
The moment of transfer of ownership and risk of accidental loss;
The procedure for agreeing on the shipping schedule.

9. Regulatory Interaction:

The contract manufacturer's mandate to assist the customer in passing inspections;
The procedure for notifying the customer of all visits by regulatory authorities to the contract manufacturer's production site;
The interaction strategy during a product market recall;
The timeline for the prompt provision of documents for safety monitoring purposes.

10. Liability of the Parties:

The contract manufacturer's liability for product quality, technology violations, loss of documentation, and breach of confidentiality;
The procedure for reimbursing the customer's expectation damages and consequential damages incurred due to product recalls, consumer claims, and regulatory sanctions;
Liability for delays, fines, and penalties for violating deadlines and quality standards;
The framework for recourse liability for violations against third parties.

11. Term, Termination, and Transition Provisions:

The term of the agreement;
Grounds for unilateral termination;
Consequences of termination: the handling of work in progress, remaining raw materials, finished products, and technical documentation;
The retention period for documentation after the agreement expires.

12. Additional Provisions:

Compliance with the requirements of Federal Law No. 152-FZ dated July 27, 2006, On Personal Data;
An anti-corruption clause;
Sanctions clauses and compliance with export-import legislation;
Applicable substantive law and dispute resolution procedure (typically, a state Arbitration Court at the defendant's location or an agreed domestic/international arbitration tribunal).

Meticulously negotiating the contractual terms will significantly help navigate regulatory requirements and mitigate liability risks.

Enforcement Landscape: Medical Device Manufacturer Liability

The liability of a medical device manufacturer is comprehensive and encompasses civil, administrative, and criminal liability. Below, we examine the specifics of each potential type of liability.

1. Civil Liability.

The civil liability of a medical device manufacturer may arise before consumers or counterparties.

In accordance with Articles 1095–1097 of the Civil Code and Law of the Russian Federation No. 2300-I dated February 7, 1992, On the Protection of Consumer Rights, the manufacturer is liable for actual damage or harm caused to the life, health, or property of a citizen due to design, manufacturing, prescription, or other defects of the medical device, as well as due to inaccurate or insufficient information about it. Notably, the manufacturer is liable even in the absence of fault in causing the harm. Exemption from liability is possible only by proving that the harm was caused by force majeure or the consumer's violation of the established usage rules.

The limitation period for filing claims is during the warranty period or shelf life. In the presence of material defects that arose prior to the transfer of the goods, claims may be filed during the device's service life, and if such a period is not established, within 10 years from the date of manufacture (Article 19 of Law No. 2300-I).

Harm is subject to compensation in full by the tortfeasor, and the consumer also has the right to demand compensation for moral damage.

Thus, in Case No. 2-699/2020 [3], Citizen T. filed a lawsuit against the Company, an importer of blood glucose test strips, to recover moral damage compensation in the amount of 30,000 rubles and legal expenses. In support of the claims, she indicated that she suffered from diabetes mellitus. She purchased a cassette of test strips at a pharmacy. However, upon use with her existing device, the cassette malfunctioned, making it impossible to measure her glucose level and, consequently, impossible to adjust the level by administering insulin. She submitted a pre-trial claim to the defendant. In response to the claim, she was informed of the possibility of transferring 5,000 rubles to her. The refusal to satisfy her claims prompted her application to the court. Based on the principles of reasonableness and fairness, the court partially satisfied the plaintiff's claims, awarding moral damage compensation in the amount of 8,000 rubles and legal expenses.

Furthermore, the consumer protection law entitles the consumer to demand a penalty for delayed compliance with demands to eliminate defects at a rate of 1% of the item's price for each day of delay, and a fine for failing to voluntarily satisfy the consumer's demands in the amount of 50 percent of the sum awarded by the court in favor of the consumer (Articles 13 and 23 of Law No. 2300-I).

The manufacturer is also liable to its buyers (medical organizations, distributors, pharmacy organizations) for breaching the terms of supply agreements: substandard quality, missed deadlines, or failure to transfer the required documents.

For breaching contractual obligations, the manufacturer may face liability in the form of contractual penalties (fines and late payment interest), interest for the use of another's funds (under Article 395 of the Civil Code), and the recovery of damages. In these matters, courts adhere to general principles of contractual liability. The amount of damages awarded directly depends on the quality of the evidentiary base: the level of detail in the contract, the presence of discrepancy protocols, timely notifications of breaches, and documentary evidence of incurred expenses. This underscores the critical importance of properly structuring contractual relationships and maintaining primary documentation.

2. Administrative Liability.

The Code of Administrative Offenses of the Russian Federation (CAO RF) contains several offenses applicable to medical device manufacturers:

Article 6.28 of the CAO RF, Violation of Established Rules in the Sphere of Circulation of Medical Devices. This is the primary offense covering a wide range of violations: the manufacture and civil circulation of unregistered devices, and violations of labeling, packaging, and operational documentation requirements. The fine for corporate officers is from 5,000 to 10,000 rubles, and for legal entities, from 30,000 to 50,000 rubles.
Article 6.33 of the CAO RF, Circulation of Falsified, Counterfeit, Substandard, and Unregistered Medical Devices. The fine for corporate officers is from 100,000 to 600,000 rubles; for individual entrepreneurs, from 100,000 to 600,000 rubles or an administrative suspension of activities for up to 90 days; and for legal entities, from 1,000,000 to 5,000,000 rubles or an administrative suspension of activities for up to 90 days.
Article 19.7 of the CAO RF, Failure to Submit Information to a State Control (Supervisory) Body (Official). The fine for corporate officers is from 300 to 500 rubles, and for legal entities, from 3,000 to 5,000 rubles.

A significant factor influencing the size of the sanction is the nature of the device, the degree of public danger of the violation, the presence or absence of actual consequences for patients, and the manufacturer's readiness to rectify the violations.

3. Enhanced Criminal Liability Regarding Medical Device Circulation Violations.

The most severe violations in the medical device sector trigger criminal liability:

Article 235.1 of the Criminal Code of the Russian Federation (CC RF), Illegal Production of Medicinal Products and Medical Devices. The elements of Part 1 cover the manufacturing of medical devices without a special permit (license), if required. Liability under Part 1 arises for manufacturing without the appropriate permit (license) regardless of the value of the manufactured devices; committing the act as part of an organized group or on a large scale constitutes the aggravated offense under Part 2, carrying a stricter penalty. A large scale is defined as the value of medical devices exceeding 100,000 rubles. The maximum penalty in the presence of aggravating circumstances is imprisonment for up to 8 years and a fine of up to 3,000,000 rubles.

As we noted earlier, as a general rule, a license is not required to manufacture medical devices, so this provision is largely unenforced in relation to medical devices.

Article 238.1 of the CC RF, Circulation of Falsified, Substandard and Unregistered Medicinal Products, Medical Devices, and the Circulation of Falsified Dietary Supplements. The actus reus of this crime consists of:

manufacturing, selling, or importing falsified medical devices into the Russian Federation;
selling or importing substandard medical devices;
illegally manufacturing, selling, or importing unregistered medical devices into the territory for the purpose of sale.

Liability arises when the act is committed on a large scale. A large scale is defined as the value of medical devices exceeding 100,000 rubles. The aggravated offense under Part 2 (committing the act by a group of persons upon prior conspiracy or by an organized group, or negligently causing severe harm to health or death of a person) is punishable by imprisonment for a term of five to eight years and a fine ranging from one to three million rubles. At the same time, Article 238.1 of the CC RF also contains a more severe offense, where the penalty reaches up to twelve years of imprisonment.

Unlike the previous provision, enforcement practice under Article 238.1 of the CC RF is quite widespread.

For example, in Case No. 1-265/2018 [4], the general director of the Company, lacking the actual capability to manufacture the "Infusion System" medical device at his own production site, entered into a manufacturing agreement in China. Subsequently, the medical devices were imported into Russia and sold as proprietary products, under the Company's trademark, and indicating a Russian manufacturing location. The court concluded that the director was guilty of committing the crime stipulated by Article 238.1 of the CC RF. Due to the voluntary compensation of damages, the criminal case was dismissed, and a court fine of 150,000 rubles was imposed.

In another Case No. 1-11/2022 [5], the general director of the Company orchestrated the purchase of critical components for X-ray machines in Italy. Then, under his instructions, the factory labels on the purchased components were replaced with the Company's labeling stickers. Subsequently, the X-ray machines were supplied under the guise of original products from a Russian manufacturer. The director was found guilty of committing a crime under Part 1 of Article 238.1 of the CC RF, and sentenced to forced labour for a term of 3 years with a 10% deduction of earnings to the state.

Criminal liability is imposed on individuals – executives and responsible corporate officers of the manufacturer. In Russian criminal law, a legal entity is not a subject of liability, but it may be simultaneously prosecuted under administrative offenses.

Furthermore, prosecution under other articles of the CC RF is not excluded depending on the actual circumstances of the committed acts, such as under Article 159 of the CC RF, "Fraud", as well as qualification under Article 327.2 of the CC RF, "Forgery of Documents for Medicinal Products or Medical Devices or Packaging of Medicinal Products or Medical Devices."

We note that criminal enforcement practice under Article 238.1 of the CC RF has intensified significantly in recent years. When sentencing, courts consider the scale of the illegal activity, the presence or absence of victims, the amount of damage caused, the degree of the defendants' awareness, and their role in organizing the activity.

Allocation of Liability in Contract Manufacturing of Medical Devices

In contract manufacturing relationships, the allocation of liability before regulators and third parties has specific characteristics.

The legal manufacturer bears primary liability to regulatory authorities and consumers since its name is indicated on the device. The contract manufacturer is liable to the customer under its contractual obligations, and to third parties – only in cases where its actions qualify as an independent offense (e.g., violation of sanitary and epidemiological rules at the production site, breach of labour legislation, etc.).

However, it is essential to note that if the manufacture of falsified or unregistered medical devices is uncovered, corporate officers of the contract manufacturer may also face liability under Article 238.1 of the CC RF if their conscious participation in the illegal activity is proven.

Litigation Landscape Regarding Medical Device Manufacturer Obligations

In addition to disputes over liability, regulatory enforcement measures can be applied to a manufacturer. Although not formally classified as liability measures, they carry significant consequences: suspension of circulation, market recall, or cancellation of the Marketing Authorization.

If the manufacturer disagrees with Roszdravnadzor's decision, it is entitled to appeal this decision in court. Challenging the decision is carried out under the rules of Chapter 24 of the Arbitration Procedure Code of the Russian Federation (APC RF), "Consideration of Cases on Challenging Non-Normative Legal Acts, Decisions, and Actions (Inaction) of Bodies Exercising Public Powers and Officials."

For the court to satisfy the application, it will be necessary to cumulatively prove the following circumstances:

the non-conformity of the challenged decision, action (inaction) with the law or other legal act;
a violation of the applicant's rights and legitimate interests in the sphere of entrepreneurial and other economic activities, or the unlawful imposition of any obligations upon it, or the creation of other obstacles to conducting entrepreneurial and other economic activities.

Let us examine disputes related to challenging Roszdravnadzor decisions using typical case categories as examples.

Thus, in Case No. A40-41621/2024 [6], Roszdravnadzor issued a Marketing Authorization to the Company for the medical device "Medical diagnostic (examination) non-sterile nitrile gloves." The registration was conducted via a simplified procedure, which subsequently required the submission of documents to conduct an expert review of quality, efficacy, and safety. Based on the analysis of the submitted documents, the registering authority notified the applicant of the need to amend the technical documentation regarding the name of the medical device, and the description of the packaging and labeling. The documents submitted by the applicant in response to the request were forwarded to the expert organization. The expert organization issued a negative opinion, which served as grounds for canceling the registration. The Company applied to the court to challenge the expert opinion and the order canceling the state registration of the medical device. During the court hearing, it was established that the reason for the negative opinion was the Company's failure to resolve the deficiencies. Specifically, the medical device labeling lacked sufficient information for the safe intended use of the device, there were no instructions for use, and information on the device disposal method was not provided. The court concluded that the quality, efficacy, and safety of the medical device were not confirmed, and there was a risk of causing harm to the health of citizens and medical workers as a result of using the medical device. The decision to cancel the registration was deemed lawful and justified.

In Case No. A40-46962/2021 [7], the manufacturer applied to the Arbitration Court seeking to invalidate Roszdravnadzor's actions to effectively withdraw goods from circulation, expressed in the issuance of informational letters. The regulator's letter reported the discovery of an X-ray machine in circulation that did not match the registration documentation set for the medical device and posed a health threat upon use. The subjects of medical device circulation were advised to check for its presence and take measures to prevent its circulation. The applicant argued that by issuing the letters, Roszdravnadzor took actions to withdraw the goods from circulation. The court denied the claims, reasoning as follows: the said Roszdravnadzor letters were issued within the scope of the control body's powers based on the results of an expert review of quality, efficacy, and safety conducted by the Center for Expertise (FSBI "VNIIIMT" of Roszdravnadzor). Furthermore, during the expert reviews, discrepancies with the requirements of the operational documentation were indeed identified. The claim was denied.

As the analysis of enforcement practice shows, Arbitration Courts consistently adhere to the position that regulatory requirements must be strictly observed: technical violations when compiling the registration dossier, discrepancies between the device's technical specifications in different documents, inconsistencies between the device's characteristics and the documentation in the registration dossier, and the lack of required testing are sufficient grounds for adopting regulatory enforcement measures.

In summary, we note that medical device manufacturing in the Russian Federation is a strictly regulated sphere where norms of national law, EAEU legislation, and standardization documents intertwine.

The manufacturer bears a broad set of obligations spanning the entire product lifecycle: from R&D and testing to post-marketing surveillance and safety corrective actions. For failing to fulfill these obligations, the manufacturer may be held liable, up to and including criminal prosecution of its executives. Meanwhile, the contract manufacturing model, actively utilized in the modern medical industry, does not exempt the legal manufacturer from its regulatory burden and liability.

To mitigate adverse consequences, the parties to the contract manufacturing of medical devices must:

Implement and maintain a certified QMS;
Structure and negotiate contractual relationships with all participants in the supply chain in detail;
Ensure continuous safety monitoring and promptly report adverse events; maintain and preserve complete manufacturing and regulatory documentation;
Navigating the evolving regulatory environment by constantly monitoring changes and proactively adapting processes to new requirements;
Perform any other actions necessary to ensure the contract manufacturing of medical devices complies with legislative requirements.

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References

See the BRACE Law Firm website: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/inspektirovanie-proizvodstva-medicinskih-izdelij.
See the BRACE Law Firm website: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/monitoring-bezopasnosti-medicinskih-izdelij-rf-eaes.
Decision of the Oktyabrsky District Court of the City of Stavropol dated March 10, 2020, in Case No. 2-699/2020.
Judgment of the Berdsk City Court of the Novosibirsk Region dated September 12, 2018, No. 1-265/2018.
Verdict of the Istra City Court of the Moscow Region dated October 5, 2022, in Case No. 1-11/2022.
Ruling of the Supreme Court of the Russian Federation No. 305-ES25-3257 dated May 6, 2025, in Case No. A40-41621/2024.
Ruling of the Supreme Court of the Russian Federation No. 305-ES22-8241 dated May 17, 2022, in Case No. A40-46962/2021.