Importation of Medical Devices into Russia: Legal, Tax, and Customs Guide

 

May 26, 2026

BRACE Law Firm©

 

Despite the intensive import substitution policy implemented in recent years, domestic medical device manufacturers cannot fully meet the demands of Russian healthcare. The Russian market remains dependent on foreign supplies. However, due to the altered geopolitical landscape and increasing attempts by importers to seek alternative channels and utilize semi-legal import schemes, the state has recently intensified control over the importation of medical devices into Russia.

Attorneys within the Healthcare and Pharmaceuticals practice at BRACE Law Firm, who specialize in the circulation of medical devices, have developed a comprehensive overview of the regulatory framework and enforcement landscape regarding medical device imports. Companies importing medical devices into the Russian Federation must consider these factors to properly structure business processes, comply with all import documentation requirements, and minimize the risks of losses, as well as administrative and criminal liability.

Regulatory Framework for Medical Device Imports

To begin this overview, we outline which products qualify as medical devices, as this classification determines whether specific regulatory requirements apply to the imported goods.

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"), medical devices comprise any instruments, apparatus, appliances, equipment, materials, and other products used for medical purposes separately or in combination with one another. These products must be intended by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring of the human body condition, medical research, restoration, replacement, or alteration of the anatomical structure or physiological functions of the body, or the prevention or termination of pregnancy, provided that their primary intended function is not achieved through pharmacological, immunological, genetic, or metabolic effects on the human body.

Under Part 4 of Article 38 of the Law on Health Protection, the circulation of medical devices within the Russian Federation is permitted only if they have undergone State registration in accordance with the procedure established by the Government of the Russian Federation, or registration pursuant to international treaties and acts constituting the law of the Eurasian Economic Union. Consequently, generally, the importation of falsified, substandard, counterfeit, or unregistered medical devices into the Russian Federation is prohibited (Part 16 of Article 38 of the Law No. 323-FZ). Part 5 of Article 38 of the Law No. 323-FZ and the implementing regulations adopted by the Government of Russia and the Ministry of Health of Russia explicitly provide for exceptions.

Below, we examine the specific requirements governing the importation of both registered and unregistered medical devices.

Importation Procedure for Registered Medical Devices into Russia

Medical devices properly registered within the Russian Federation or under Eurasian Economic Union law do not require any special permits from healthcare authorities.

A national Marketing Authorization, an extract from the State Register of Medical Devices, or a unified EAEU registration certificate serves as the legal basis for importation, confirming product registration alongside standard shipping documentation:

• A foreign trade contract confirming the sale;
• Transportation documents;
• Other documents are required to verify the transaction for customs clearance or prescribed by legislation for specific types of medical devices.

The specific requirements for these documents are detailed in the subsequent sections of this article.

Importers of registered medical devices must verify that the Marketing Authorization remains valid, that all intended models (brands) and components are explicitly listed in the registration files, and that the cargo is accompanied by mandatory technical and operational documentation.

Parallel Importation of Registered Medical Devices

In recent years, attempts to import registered medical devices via parallel channels have become increasingly common. Parallel import refers to the importation of genuine goods bearing a right holder's trademark without their express authorization. This practice became permissible in Russia in 2022 following Decree of the Government of the Russian Federation No. 506 dated March 29, 2022, On Goods (Groups of Goods) in Respect of Which Certain Provisions of the Civil Code of the Russian Federation on the Protection of Exclusive Rights to Results of Intellectual Activity Expressed in Such Goods and Means of Individualization with Which Such Goods Are Marked Cannot Be Applied. Order of the Ministry of Industry and Trade of Russia No. 2701 dated July 21, 2023, subsequently approved the List of Goods (Groups of Goods) Eligible for Parallel Import.

As of the compilation of this article, the List includes only reagents and consumables for cancer treatment equipment manufactured by Miltenyi Biotec, which is utilized in bone marrow transplants. However, specific exclusionary clauses remove all other medical devices from the List. Consequently, parallel import of medical devices remains generally unauthorized, save for specific items explicitly designated within the List of the Ministry of Industry and Trade of Russia with an express proviso rendering them applicable to medical devices.

Parallel importation of medical devices inevitably triggers legal disputes between trademark owners and importers, while also exposing businesses to operational risks, such as a customer's refusal to accept the delivered goods.

For example, in Case No. A21-3725/2023, [1] a business entity filed a lawsuit in an arbitration court against an individual entrepreneur. The claimant sought to declare in vitro diagnostic medical devices counterfeit, which bore the trademarks R., and were supplied to a hospital under a contract, and demanded their seizure and destruction. During the proceedings, the court established that the claimant was the sole authorized importer of these products within the Russian Federation and the exclusive licensee authorized to use the trademarks "R.". Crucially, neither the right holder nor the claimant had released the contractually supplied goods into civil circulation within the Russian Federation. The court issued an inquiry to the manufacturer, whose response confirmed that the items were produced specifically for the US market. The supply chain was traced from a Polish company to a Kazakh company, then to the Russian company that handled the actual import, and ultimately to the defendant. Since the manufactured goods were not intended for sale in Russia, the individual entrepreneur had applied additional self-adhesive labeling containing product descriptions in Russian. The court concluded that the packaging failed to match the registration dossier for the medical device and the instructions for use approved for distribution within the Russian Federation.

Following the review of the case, the court ruled that genuine goods bearing the disputed trademarks and imported into the Russian Federation without the authorization of the right holders are counterfeit. The court clarified that in parallel import disputes, the unlawful use of a trademark does not stem from illegal application of the marks to unoriginal (fake) products, but rather from the unauthorized importation and subsequent commercialization of the goods within the Russian Federation. The court sustained the claim in its entirety.[2]

Notably, when Roszdravnadzor detects non-compliance with labeling or packaging requirements, it typically classifies the product as a substandard medical device, [3] given that a finding of counterfeit status falls exclusively within the purview of the judiciary.

Consequently, when importing registered medical devices into the Russian Federation, the importer must thoroughly verify the accuracy and validity of the product documentation, as well as the absolute legality of the import channel.

Importation of Unregistered Medical Devices for State Registration Purposes

If a company intends to register a foreign medical device in Russia, it must import a specified volume of samples to complete mandatory pre-registration procedures, including technical testing, toxicological evaluation, clinical trials, and pattern approval testing for measuring instruments.

Order of the Ministry of Health of Russia No. 201n dated May 2, 2023, On Approval of the Procedure for the Importation of Medical Devices into the Russian Federation for the Purpose of State Registration regulates the importation of such devices. This regulation also applies to the importation of already registered medical devices when updates are required for documents contained within the medical device registration dossier.

The right to import samples extends to the manufacturer of the medical device, its authorized representative, or any other party executing the importation into the Russian Federation for State registration purposes.

The total volume of imported samples depends on the recommendations of the institutions conducting the designated tests and studies.

Importers may introduce these medical devices only after providing a notification to Roszdravnadzor. To execute this, the applicant submits a notification of intent to import the medical device through the applicant's personal account on the State Services Portal (Gosuslugi), specifying information regarding:

• The medical device (the name of the medical device, model, configuration, quantity, serial number, manufacture date, expiration date, and intended use);
• The applicant;
• The manufacturer;
• The facilities where the tests and studies are scheduled to take place.

Roszdravnadzor acknowledges receipt of the notification within one business day. The authority logs the details of the submitted notification into the Register of Notifications, maintained on its official website. If an additional volume of samples is required for testing or evaluation, the applicant must resubmit the notification.

According to data provided by Roszdravnadzor, [4] common errors committed by applicants include:

• Incomplete data regarding the device configuration or discrepancies between the sample details in the application and the testing agreement (such as batch/lot numbers, serial numbers, etc.);
• Discrepancies between applicant details and official company documents (the Unified State Register of Legal Entities, Taxpayer Identification Number, Main State Registration Number, etc.), or the absence of power of attorney for the signatory;
• Failure to provide a Russian translation of the document verifying the authority of the manufacturer's authorized representative, or a translation that is not properly notarized;
• Omission of an explicit clause in the representative's authorization granting the right to represent interests regarding "the circulation of medical devices within the Russian Federation".

Importation of Exempt Unregistered Medical Devices

Part 5 of Article 38 of the Law on Health Protection specifies the categories of medical devices exempt from State registration within the Russian Federation. These exemptions include:

1. Medical devices imported for:

• Conducting research and trials, including scientific research;
• Rendering medical assistance to participants in international cultural or sporting events and international expeditions, or for exhibition purposes;
• Delivering humanitarian aid.

2. Medical devices manufactured within a member state under custom patient orders exclusively for personal use, which meet specific requirements outlined in a prescription issued by a healthcare professional.
3. Medical devices configured as first-aid kits, sets, packs, and combinations consisting of registered medical devices (excluding power-dependent or energy-sourced medical devices) or medicinal products united in common packaging, provided that the secondary (consumer) packaging – or primary packaging if secondary packaging is not envisaged – and its labeling remain intact.

Russian legislation permits the importation of such medical devices for purposes unrelated to their State registration. Decree of the Government of the Russian Federation No. 1321 dated August 9, 2021, On Approval of the Rules for the Importation into the Russian Federation of Medical Devices Specified in Clauses 1, 2, and 5 of Part 5 of Article 38 of the Federal Law On the Fundamentals of Health Protection of Citizens in the Russian Federation governs this importation procedure (the "Decree No. 1321"). Below, we examine the distinct features of imports under these grounds.

Only legal entities or individual entrepreneurs who have filed a notification of business activity in the sphere of medical device circulation pursuant to Decree of the Government of the Russian Federation No. 584 dated July 16, 2009, [5] may execute the importation of custom-made medical devices and first-aid kits.

For custom-manufactured medical devices, the accompanying documentation must include a copy of the prescription issued by a healthcare professional, which confirms the necessity of utilizing the imported medical device for the specific patient and clearly states their full name.

Participants and organizers of exhibitions, international cultural or sporting events, and international expeditions manage the importation of medical devices intended to provide medical assistance to event participants.

Decree of the Government of the Russian Federation No. 1335 dated December 4, 1999, On Approval of the Procedure for Providing Humanitarian Aid (Assistance) to the Russian Federation governs the importation of medical devices as humanitarian assistance. To clear customs, the importer must present a certificate confirming the status of the goods as humanitarian aid (assistance), issued by the Commission on International Humanitarian and Technical Assistance under the Government of the Russian Federation.

Within three business days following the actual import date, the importer must submit the following data to Roszdravnadzor via its automated information system:

1. Information regarding the imported medical device:

• The name, variation or model, configuration, and list of components (if any), as well as the serial (batch/lot) or factory identification number for each device;
• Registration records in the country of origin or country of manufacture (if the device is subject to registration);
• The name and country of the manufacturer, alongside the manufacturing facility address;
• The total volume of the imported batch or lot (in units);
• The date of manufacture;
• The expiration date or service life of the medical device;
• The projected duration of the imported medical devices' stay within the Russian Federation;
• The scheduled dates and volumes for the subsequent re-exportation, disposal, or destruction of the imported items.

2. Information regarding the importing party:

• The full and abbreviated name, corporate legal form, address, Taxpayer Identification Number, and Main State Registration Number of the legal entity;
• The full name, residential address, identity document details, Main State Registration Number, telephone number, and email address of the individual entrepreneur.

3. Identical information regarding the end recipient or user of the medical device.

4. Other data:

• A digital copy of the prescription issued by a healthcare professional, confirming that the imported device is intended exclusively for the personal use of the patient;
• Information regarding the organizer or the authorized representative of the organizer of the international cultural or sporting events, expeditions, and exhibitions;
• Details concerning the specific purpose of the trials, testing, or scientific research motivating the import. Crucially, the objective of such testing cannot be to determine the feasibility of registering the medical device under EAEU law.

Importation of Unregistered Medical Devices on Compassionate Grounds for Specific Patients

Decree No. 1321 establishes another mechanism for importing unregistered medical devices: to provide medical care on compassionate grounds (life-saving indications) for a specific patient. Unlike the aforementioned scenarios, however, this importation requires an explicit permit from Roszdravnadzor.

Decree of the Government of the Russian Federation No. 1590 dated September 22, 2021, On Approval of the Rules for Issuing a Permit for the Importation of a Medical Device into the Russian Federation to Provide Medical Care on Life-Saving Indications for a Specific Patient governs the permit acquisition procedure.

Only a legal entity or an individual entrepreneur that has submitted a notification of activity in the sphere of medical device circulation may obtain the import permit. To initiate this, the applicant submits an electronic application to Roszdravnadzor via the Single Portal of State Services. The application must include the following supporting documents:

1. A copy of the minutes of the medical commission's conclusion or a consultation of physicians from the healthcare institution providing medical assistance to the patient regarding the prescription of the medical device (stating the product name, the required quantity, and the specific condition for which the unregistered device is imported), or a copy of the decision of the expert council of the Circle of Kindness Foundation to provide an unregistered medical device to a specific child with a severe life-threatening or chronic illness.

The board of the Circle of Kindness Foundation defines the list of medical devices purchased by the foundation to deliver medical care to children with severe life-threatening or chronic conditions. Specifically, this list includes wound dressings, absorbent products, Stanmore Implants extendable endoprostheses, bone compression-distraction appliances, and similar items. As a general rule, the criteria for a favorable procurement decision are as follows:

• The child's condition is included in the List of Life-Threatening and Chronic Illnesses approved by the foundation;
• Clear medical indications necessitate this specific medical device;
• A registered equivalent cannot substitute for the device, or no analog exists within the Russian Federation;
• The medical device is registered by the regulatory authorities of its country of origin.

2. A copy of the manufacturer's operational documentation for the medical device.
3. Full-view photographic images of the medical device along with all components required for its intended application, which must clearly display the labeling text.

Within three business days, Roszdravnadzor verifies the passport data or state birth registration records of the patient prescribed the device, along with all submitted documentation.

Following verification, the state authority executes the following actions within two business days:

• Issues a decision to grant the permit or refuses issuance, stating the specific grounds for refusal;
• Logs the corresponding entry into the Register of Permits, maintained within the automated information system of Roszdravnadzor.

The permit becomes legally valid upon entry into the register. The permit remains effective for 30 days, and no issuance fee is charged.

The grounds for refusing permit issuance comprise:

• Detection of incomplete or inaccurate data within the application and attached documents during the verification process;
• Submission of an application and import documents for products that do not qualify as medical devices;
• Possession by Roszdravnadzor of safety monitoring data indicating adverse reactions, side effects, or specific drug-device interactions that pose a threat to the life and health of citizens or medical personnel, provided the manufacturer has not clarified the measures deployed to eliminate such risks;
• Non-compliance of the applicant's enhanced qualified electronic signature with the requirements of the Federal Law On Electronic Signatures.

A refusal to issue the permit does not preclude the applicant from resubmitting the application.

The party executing the importation of medical devices intended for healthcare provision must file a notification via the automated information system to Roszdravnadzor within three business days, adhering to the procedure established by Decree No. 1321.

Importation of Unregistered Medical Devices for Emergency Prevention and Treatment of Contagious Diseases

In response to the coronavirus pandemic in 2020, Decree of the Government of the Russian Federation No. 430 dated April 3, 2020, [6] introduced specific regulations governing the circulation of medical devices, which established certain relaxations for importing unregistered products.

Pursuant to Clause 10 of the designated act, the importation of unregistered single-use medical devices listed in Annex No. 1 to Decree No. 430 is permitted without a Roszdravnadzor permit, provided that these items are properly registered in their country of manufacture.

The party executing the import must transmit data regarding the batches or lots of the imported medical devices to Roszdravnadzor within three business days of import, matching the scope detailed in Annex No. 2 to Decree No. 430. Importers must submit this information through the electronic service on the Roszdravnadzor website titled Importation of Unregistered Medical Devices.

Furthermore, the applicant remains under a weekly obligation until January 1, 2028, to submit records regarding the commercialization, re-exportation, or destruction of these items through the aforementioned digital service.

Supply Contracts for Medical Device Importation

Structurally, a medical device supply contract operates as an international contract of sale. Consequently, parties must explicitly define the governing law to resolve any issues omitted from the core text of the agreement.

When drafting the contract, we recommend including the following provisions:

• The subject matter of the contract (detailing the name, model, configuration, quantity, country of origin, and Marketing Authorization number of the purchased medical device);
• Quality requirements (applicable standards, shelf life or warranty periods, and specifications for accompanying documentation, labeling, and packaging);
• Delivery terms;
• Pricing and payment terms;
• Dispute resolution procedures.

Further details on international contracting are available in our dedicated practice area International Trade and Customs Law: Legal Analysis and Practice.[7] However, to effectively mitigate commercial exposure, businesses should retain legal counsel specializing in cross-border trade and Life Sciences law.

Customs Clearance and Documentation Requirements for Medical Devices

When importing medical devices for commercial distribution, the importer must file a goods declaration (customs declaration) – a comprehensive document detailing the imported cargo. Additionally, the importer must submit the following records to customs authorities:

• A foreign trade contract confirming the transaction;
• Transportation documentation;
• A valid Marketing Authorization or an extract from the State Register of Medical Devices;
• A Roszdravnadzor permit or notification for unregistered devices, where mandated by Russian legislation;
• An import license from the Ministry of Industry and Trade of Russia if the cargo falls under radio-electronic equipment or high-frequency devices (the list of such goods is established by Decision of the Collegium of the Eurasian Economic Commission No. 30 dated April 21, 2015.[8] For example, high-frequency devices include MRI machines and pacemakers. Decision of the Council of the EEC No. 125 dated November 24, 2023, governs the license issuance procedure. [9] The issuance follows product testing at Radio Frequency Center laboratories. Consequently, the importer must initially introduce product samples for testing. A license is unnecessary if data on the imported device is already listed in the Unified Register of Radio-Electronic Equipment and High-Frequency Devices for Civil Use);
• Alternative documents required to substantiate the transaction and facilitate customs clearance.

Tax and Customs Landscapes Governing Medical Device Importation

The importation of medical devices into the Russian Federation entails the payment of mandatory customs charges: (1) import customs duties and (2) value-added tax (the "VAT").

Although legislation grants several customs, tariff, and tax preferences for medical devices, their practical implementation triggers substantial litigation. These disputes primarily stem from the classification of goods under the Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union (the "TN VED EAEU"). Below, we examine the core rules and established judicial trends.

Tariff Regulation Framework for Medical Devices

Import customs duties are collected pursuant to the Unified Customs Tariff of the Eurasian Economic Union, approved by Decision of the Council of the Eurasian Economic Commission No. 80 dated September 14, 2021, On Approval of the Unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union and the Unified Customs Tariff of the Eurasian Economic Union. The vast majority of medical devices are classified under Chapter 90 of the TN VED EAEU (specifically, heading 9018 – instruments and appliances used in medical, surgical, dental, or veterinary sciences; as well as headings 9019, 9020, 9021, and 9022; alongside specific entries in Chapters 30, 38, 39, 84, 85, and 94). Zero or preferential import duty rates apply to numerous headings within Chapter 90 of the TN VED EAEU.

Under Article 20 of the Customs Code of the Eurasian Economic Union (the "CC EAEU"), the declarant independently classifies goods under the TN VED EAEU during declaration. Upon detecting an incorrect classification, the customs authority may issue a formal classification decision pursuant to Article 21 of the CC EAEU. The declarant must execute this decision, though it remains subject to appeal under Chapter 51 of Federal Law No. 289-FZ dated August 3, 2018, On Customs Regulation in the Russian Federation and on Amending Certain Legislative Acts of the Russian Federation. When classifying specific product lines, customs authorities rely on the Clarifications of the FCS of Russia on the Classification of Certain Types of Goods in Accordance with the TN VED EAEU, approved by Order of the FCS of Russia No. 995 dated November 17, 2021.

For distinct classes of medical goods, EAEU law establishes tariff preferences. Specifically, under Clauses 7.1.32 and 7.1.33 of Decision of the Commission of the Customs Union No. 130 dated November 27, 2009, On Unified Customs and Tariff Regulation of the Eurasian Economic Union, imports designed for emergency response or categorised as critical imports are eligible for an exemption from import duties. A distinct framework governs items imported as gratuitous aid (assistance) to the Russian Federation under Federal Law No. 95-FZ dated May 4, 1999, provided the importer secures a matching certificate from the Commission on International Humanitarian and Technical Assistance under the Government of the Russian Federation.

VAT Exemptions on Medical Device Importation

VAT Exemption (Zero Rate). The importation of goods into the Russian Federation constitutes an event subject to VAT under Subclause 4 of Clause 1 of Article 146 of the Tax Code of the Russian Federation (the "TC RF"). Concurrently, Subclause 2 of Article 150 of the TC RF, read in conjunction with Subclause 1 of Clause 2 of Article 149 of the TC RF, exempts the importation of domestic and foreign medical products listed by the Government of the Russian Federation from VAT. To claim this exemption, the importer must present a valid Marketing Authorization issued under EAEU law or Russian legislation to the customs or tax authority.

Decree of the Government of the Russian Federation No. 1042 dated September 30, 2015, On Approval of the List of Medical Goods the Sale of Which in the Russian Federation and the Importation of Which into the Russian Federation and Other Territories Under Its Jurisdiction Are Exempt from Value-Added Tax establishes the relevant list (the "List No. 1042"). Within the List No. 1042, medical goods codes are mapped simultaneously to the TN VED EAEU and the All-Russian Classifier of Products by Economic Activity (OKPD 2; for products registered prior to January 1, 2017, the All-Russian Product Classifier code OK 005-93 is factored in).

Judicial practice and administrative guidance outline the conditions required to secure a VAT exemption upon importation:

1. The goods declaration must state a TN VED EAEU code explicitly included in Section I of the List No. 1042;
2. The OKPD 2 code (or OK 005-93 code for legacy certificates) specified in the Marketing Authorization must perfectly match the code cross-referenced in the List No. 1042 against the corresponding TN VED EAEU code;
3. The Marketing Authorization must remain fully effective on the date of entry. Decision of the Supreme Court of the Russian Federation No. AKPI16-289 dated May 25, 2016, emphasized that the TN VED EAEU and OKP/OKPD 2 codes must match concurrently within the List No. 1042. Because the List No. 1042 serves as the unified basis for tax exemptions both at the border and throughout the domestic trade environment, companies must also satisfy these cumulative criteria during subsequent commercial distribution (Ruling of the Supreme Court of the Russian Federation No. 305-KG18-19119 dated March 14, 2019).

Reduced 10% VAT Rate. If a medical device is not fully exempt under the List No. 1042, a reduced 10% VAT rate may apply during importation and domestic distribution pursuant to Subclause 4 of Clause 2 and Clause 5 of Article 164 of the TC RF. Decree of the Government of the Russian Federation No. 688 dated September 15, 2008, On Approval of the Lists of Medical Goods Codes Taxed with Value-Added Tax at a 10 Percent Tax Rate sets forth the classifications eligible for this preferential treatment (the "List No. 688").

The List No. 688 contains two separate tables: one arranged by OKPD 2 codes (applicable to domestic sales) and another by TN VED EAEU codes (applicable to import transactions). Availing of the reduced tax rate is strictly conditional upon presenting a valid Marketing Authorization for the medical device.

Standard 22% VAT Rate. Medical devices omitted from both the List No. 1042 and the List No. 688 face the standard 22% VAT rate upon import and subsequent domestic commercialization.

Common Customs Disputes and Corporate Risk Mitigation

The most frequent catalyst for litigation is a mismatch between the TN VED EAEU code declared by the importer (or reassigned by customs) and the tariff code matched against the corresponding OKPD 2 entry in the List No. 1042 or the List No. 688. A post-entry reclassification by customs authorities can result in a total forfeiture of the tax exemption or preferential rate, leading to retroactive assessments at the standard 22% VAT rate along with late payment penalties. If the judiciary subsequently voids the customs decision, the overpaid VAT sums are refundable under Chapter 11 of Federal Law No. 289-FZ dated August 3, 2018, provided the importer amends the initial goods declaration accordingly (Clause 29 of Decree of the Plenum of the Supreme Court of the Russian Federation No. 18 dated May 12, 2016, On Certain Issues of the Application of Customs Legislation by Courts).

The importation of incomplete medical systems and standalone components presents a distinct regulatory hurdle. According to the consistent stance of the Ministry of Finance of Russia, because the terms incomplete medical device and components are absent from Subclause 1 of Clause 2 of Article 149 of the TC RF, Article 38 of the Law No. 323-FZ, and the product nomenclature approved by Order of the Ministry of Health of Russia No. 4n dated June 6, 2012, extending preferential VAT treatment to these items is impermissible without formal amendments to the Code (Guidance Letter of the Ministry of Finance of Russia No. 03-07-07/14844 dated February 26, 2026). Conversely, judicial bodies occasionally adopt a more flexible approach, evaluating the actual functional purpose of the goods and the records within the registration dossier.

For legacy certificates detailing OK 005-93 (OKP) codes rather than OKPD 2 classifications, importers must utilize the OKP-OKPD 2 correlation keys published on the official website of the Ministry of Economic Development of Russia to cross-reference entries against the List No. 1042 and the List No. 688 (Letter of the Federal Tax Service No. SD-4-3/8670@ dated July 30, 2024). If an unambiguous correlation cannot be established, the importer should seek formal clarification from the Ministry of Health of Russia regarding product qualification, or from the Ministry of Industry and Trade of Russia as the primary architect of the List No. 688. Submitting an individual petition to the Ministry of Finance of Russia under Subclause 2 of Clause 1 of Article 21 of the TC RF yields binding written guidance, which legally isolates the taxpayer from liability for tax offenses under Subclause 3 of Clause 1 of Article 111 of the TC RF.

Strategic Protocols for Mitigating Tariff and Fiscal Risks

To navigate the current enforcement landscape effectively, medical device importers should implement the following protocols:

1. Reconcile the OKPD 2 (OK 005-93) codes listed in the Marketing Authorization against the latest versions of the List No. 1042 and the List No. 688 prior to submitting the customs declaration, ensuring absolute alignment with the intended TN VED EAEU classification;
2. Evaluate established customs enforcement trends, administrative rulings from the FCS of Russia, and judicial precedents regarding identical or structurally similar commodity groups;
3. Assess the viability of securing a binding pre-entry classification ruling under Article 18 of the CC EAEU and Chapter 9 of Federal Law No. 289-FZ dated August 3, 2018, if a substantial risk of tariff reclassification exists;
4. Maintain a meticulous audit trail, including all commercial, shipping, and regulatory files, to facilitate the recovery of overpaid taxes should retroactive adjustments become necessary.

Liability and Enforcement Risks for Importation Violations

Parties executing the importation of medical devices into the Russian Federation in violation of statutory rules face severe exposure to both administrative and criminal penalties.

Specifically, Article 238.1 of the Criminal Code of the Russian Federation establishes criminal liability for the importation of falsified or substandard medical devices, as well as the illicit import of unregistered medical devices for distribution purposes, when executed on a large scale. Statutory provisions define a large scale as any transaction where the total value of the medical devices exceeds 100,000 rubles.

An intent to distribute the imported products represents an essential element of the offense. Notably, this criminal provision does not apply if healthcare legislation expressly permits the importation of the unregistered items. Furthermore, pursuant to Note 3 of Article 238.1 of the Criminal Code, criminal exposure is negated if the unregistered devices are not manufactured within the Russian Federation, if their distribution or importation is authorized under domestic health law, or if the World Health Organization has recommended them for therapeutic use.

The maximum penalty for a base offense committed without aggravating factors is imprisonment for up to 5 years. Concurrently, courts may assess ancillary penalties, including criminal fines reaching 2,000,000 rubles (or an amount equivalent to the defendant's wages for up to 2 years), alongside a professional disqualification barring the individual from holding specific offices or engaging in designated business activities for up to 3 years.

Prosecutorial records confirm robust enforcement under Article 238.1 of the Criminal Code. For instance, in Case No. 1-271/2019,[10] the defendant, acting as the general director of a corporate entity, executed a supply contract with Chinese nationals for dental treatment units. During border clearance, customs authorities determined that the imported units lacked valid registration within the Russian Federation.

At trial, the defendant argued that the delivered models did not match his original order due to a warehouse dispatch error in China. The court rejected this defense, noting information from the manufacturer indicating that the units allegedly intended for shipment had never been supplied to the company or its Chinese partner. By judicial verdict, the defendant was convicted under Part 1 of Article 238.1 of the Criminal Code for the illicit importation of unregistered medical devices on a large scale for distribution purposes. The court handed down a 3-year suspended prison sentence with a 2-year probationary term and a fine of 500,000 rubles.

If identical acts lack the thresholds required for criminal prosecution (e.g., fall below the large-scale monetary limit), the party faces administrative exposure under Part 2 of Article 6.33 of the Code of Administrative Offenses of the Russian Federation (the "CAO RF"). The statutory penalties under this provision encompass administrative fines ranging from 70,000 to 100,000 rubles for citizens; 100,000 to 600,000 rubles for corporate officers and individual entrepreneurs; and 1,000,000 to 5,000,000 rubles for corporate entities. Alternatively, corporate entities and individual entrepreneurs may face a compulsory administrative suspension of business operations for up to 90 days. The explicit statutory Note to Article 6.33 of the CAO RF clarifies that the commercialization or importation of unregistered medical devices does not constitute an administrative infraction if the activities are sanctioned under public health legislation, the devices are not produced domestically, or they are explicitly recommended for use by the World Health Organization.

In summary, importing medical devices remains an intricate regulatory procedure requiring deep legislative expertise, precise documentation management, and a complete understanding of procedural nuances. Compliance errors or cost-cutting strategies frequently trigger immediate financial losses, alongside severe exposures to administrative or criminal liability. We highly recommend engaging qualified legal specialists to structure and guide all medical device import operations.

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References

[1] Ruling of the Supreme Court of the Russian Federation No. 307-ES24-15984 dated October 1, 2024, in Case No. A21-3725/2023.

[2] Ibid.

[3] Letter of Roszdravnadzor No. 01I-1483/24 dated December 26, 2024, On a Substandard Medical Device; Letter of Roszdravnadzor No. 01I-1484/24 dated December 26, 2024, On a Substandard Medical Device.

[4] Roszdravnadzor Official Website: https://roszdravnadzor.gov.ru/medproducts/import/news/26149.

[5] Decree of the Government of the Russian Federation No. 584 dated July 16, 2009, On the Notification Procedure for Commencing Certain Types of Entrepreneurial Activity.

[6] Decree of the Government of the Russian Federation No. 430 dated April 3, 2020, On Specifics of the Circulation of Medical Devices, Including State Registration of a Batch (Lot) of a Medical Device.

[7] See: https://brace-lf.com/informaciya/pravo-i-mezhdunarodnaya-torgovlya.

[8] Decision of the Collegium of the Eurasian Economic Commission No. 30 dated April 21, 2015, On Non-Tariff Regulation Measures.

[9] Decision of the Council of the EAEU No. 125 dated November 24, 2023, On Approval of the Rules for Issuing Licenses and Permits for the Export and (or) Import of Goods Included in the Unified List of Goods to Which Non-Tariff Regulation Measures Are Applied in Trade with Third Countries.

[10] Appellate Ruling No. 22-3189/2020 dated July 21, 2020, in Case No. 1-271/2019.