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We present an overview of the most significant regulatory updates, legislative amendments, and statutory clarifications governing the market circulation of medical devices. Notably, regulatory bodies introduced a substantial volume of normative legal acts across the Life Sciences sector, both at the national level within the Russian Federation and supranationally within the Eurasian Economic Union (EAEU).
In compiling this digest, our legal counsel evaluated the operational impact of these legislative adjustments on the industry, specifically focusing on the compliance risks and practical challenges that medical device market participants may encounter.
This digest provides a comprehensive legal analysis of these critical regulatory shifts and other milestone industry developments.
1. Approval of the Standardized Medical Device List for Upgrading State-Subvented Oncology Facilities
Order of the Ministry of Health of the Russian Federation No. 56n, dated February 12, 2019, “On Approval of the List of Medical Devices for Re-equipping Medical Organizations Subordinate to the Executive Authorities of the Constituent Entities of the Russian Federation that Provide Medical Care to Patients with Oncological Diseases”
Pursuant to the Rules for Providing and Distributing Interbudgetary Transfers from the Federal Budget to the Budgets of the Constituent Entities of the Russian Federation for Re-equipping Medical Organizations Providing Medical Care to Oncology Patients, approved by Government Decree No. 1772, the federal government allocates these funds to co-finance regional expenditures. These obligations arise as regional authorities establish conditions within their statutory powers to improve healthcare accessibility and re-equip medical facilities with specific medical devices designated by the Ministry of Health of the Russian Federation.
To execute this regulatory mandate, the Ministry approved a comprehensive list comprising 147 categories of medical devices, including continuous mechanical ventilation and anesthesia machines, radiotherapy systems, and endovideosurgery complexes.
2. Ministry of Health Issues Guidance on the Distribution of Medical Consumables for Diabetic Patients
Recommendations on Organizing the Provision of Consumables to Citizens with Diabetes Mellitus Who Have Installed Insulin Pumps, Approved by the Ministry of Health of the Russian Federation
On March 28, 2019, the Ministry of Health published official guidance on its website clarifying that the statutory Nomenclature of Medical Services (approved by Ministry of Health Order No. 804n) does not encompass the service of providing consumables for insulin pumps.
Consequently, the Compulsory Medical Insurance (OMS) fund does not cover monthly insulin pump consumables, whether distributed during round-the-clock inpatient treatment or day hospital stays.
Nevertheless, specific categories of citizens, including individuals and children with disabilities, retain the legal right to claim a statutory package of social services. This package grants them federal budget-funded medical devices prescribed by licensed physicians.
Government Decree No. 3053-r explicitly includes insulin pump consumables within the approved schedule of prescription-based medical devices available under this social safety net.
Furthermore, the guidelines underscore that regional state authorities possess the discretionary power, under the Territorial Programs of State Guarantees, to integrate insulin pump consumables into local lists of medical devices distributed to specific patient populations either entirely free of charge or at a 50% discount during outpatient treatment.
3. Mandatory Standardized Equipment Requirements Imposed on Mobile Medical Units
Order of the Ministry of Health of the Russian Federation No. 164n, dated March 27, 2019, “On Amending the Regulation on Organizing the Provision of Primary Health Care to the Adult Population, Approved by Order of the Ministry of Health and Social Development of the Russian Federation No. 543n, Dated May 15, 2012” (Registered with the Ministry of Justice of the Russian Federation on April 22, 2019, Registration No. 54470)
The updated Regulation introduces concrete equipment standards for mobile medical teams, filling a previous regulatory void where no explicit hardware mandates existed.
The current framework establishes five separate equipment standards tailored to distinct medical activities: primary healthcare delivery, preventative medical examinations, initial-stage health screenings, fluorography, and mammography.
Healthcare operators must equip every mobile medical unit with a specialized mobile medical vehicle. The technical specifications and internal diagnostic devices vary depending on the intended clinical procedures.
To deliver primary medical care, the vehicle must house 32 distinct categories of equipment. Essential instruments include:
• A portable three- or six-channel electrocardiograph integrated with a remote telemetry system;
• A handheld blood glucose analyzer complete with corresponding diagnostic test strips;
• An automated external defibrillator (AED);
• Disposable cricothyrotomy kits for emergency airway management;
• Medical oxygen inhalers;
• Ultraviolet germicidal air irradiation systems;
• Manual resuscitators (Ambu bags).
Medical staff can perform preventative check-ups provided the vehicle contains the primary healthcare equipment alongside three additional specialized instruments: a rapid cholesterol analyzer with test strips, a transpalpebral tonometer for intraocular pressure tracking, and a mobile fluorograph.
Conducting initial-stage health screenings requires occult blood fecal test strips and a mammography unit in addition to the standard baseline setup.
Dedicated mobile teams must utilize specialized vehicles equipped with a heavy-duty fluorograph or mammograph respectively, depending on their specific screening mission.
Regulators require all mobile medical vehicles to feature radio communication hardware and an automated navigation and dispatch system terminal compatible with GLONASS and GPS, complete with emergency panic button capabilities.
4. Statutory Rules Enacted for Tracking the Turnover Volume of Pharmaceutical Alcohol and Medicated Products
Decree of the Government of the Russian Federation No. 472, dated April 20, 2019, “On the Procedure for Accounting and Declaring the Volume of Production, Turnover, and (or) Use of the Pharmaceutical Substance of Ethyl Alcohol (Ethanol), as well as the Production, Manufacture, and (or) Turnover (Except for Retail Sale) of Alcohol-Containing Medicinal Products and (or) Alcohol-Containing Medical Devices and on Amending Decree of the Government of the Russian Federation No. 380, Dated June 19, 2006” (together with the “Rules for Accounting for the Volume of Production, Turnover, and (or) Use of the Pharmaceutical Substance of Ethyl Alcohol (Ethanol), as well as the Production, Manufacture, and (or) Turnover (Except for Retail Sale) of Alcohol-Containing Medicinal Products and (or) Alcohol-Containing Medical Devices”)
These regulations enable pharmaceutical manufacturers, distributors, healthcare institutions, and licensed pharmacies to fulfill tracking mandates originally introduced in January 2018.
Two separate legal acts entered into force on May 8, 2019.
The first decree establishes the framework for volume accounting regarding:
• The manufacturing, turnover, and utilization of bulk ethanol pharmaceutical substances;
• The commercial production, compounding, and wholesale distribution of alcohol-containing pharmaceuticals and medical devices.
To log ethanol turnover, companies must deploy certified data recording hardware that transmits real-time information to the Unified State Automated Information System (EGAIS).
The law carves out narrow exceptions. Pharmacies and medical clinics purchasing ethanol as raw material or excipient for compounding medicinal preparations or medical devices must manage their tracking obligations based on threshold volumes:
• Utilizing automated recording and telecommunication hardware if annual purchasing volumes exceed 200 decaliters;
• Maintaining manual logs without automated infrastructure if annual volumes remain at or below 200 decaliters.
Ethanol substance manufacturers must account for and declare all production, supply, and internal consumption volumes under these newly instituted reporting guidelines.
The secondary document outlines the technical procedures for submitting production and turnover declarations. The Government will subsequently release specific exempt lists detailing which alcohol-containing medicines and medical devices fall outside these requirements.
5. Implementation of EAEU Classification Criteria for Demarking Medical Devices
Recommendation of the Board of the Eurasian Economic Commission No. 25, dated November 12, 2018, “On Criteria for Classifying Products as Medical Devices Within the Framework of the Eurasian Economic Union”
The Board of the Eurasian Economic Commission recommended the application of these guidelines starting May 16, 2019. This framework assists manufacturers preparing technical documentation for registration and expert evaluation under unified EAEU protocols.
The guidance delineates 12 distinct product categories:
• Cosmetics, perfumery, and personal hygiene products;
• Disinfection agents and specialized sterilization equipment;
• General-purpose commodities and utilities;
• Assistive and rehabilitative devices for individuals with disabilities;
• Sports equipment and physical therapy systems;
• Personal protective equipment (PPE);
• Standalone and embedded software solutions;
• Specialized packaging and storage units for medical devices;
• Physiotherapy devices and consumer health products;
• Specialized medical furniture;
• Drug-device combination products;
• In vitro diagnostic (IVD) systems.
The document details specific functional attributes for each category to clarify whether a product meets the legal definition of a medical device.
6. Roszdravnadzor Vested with Medical Device Manufacturing Inspection Authority
Decree of the Government of the Russian Federation No. 685, dated May 29, 2019, “On Amending Certain Acts of the Government of the Russian Federation”
The Russian Government officially authorized Roszdravnadzor to organize production site inspections and audit independent inspecting bodies. These activities must align with the Requirements for the Implementation, Maintenance, and Evaluation of Quality Management Systems for Medical Devices Based on Potential Risks, approved by EAEU Council Decision No. 106.
7. Methodological Guidelines Introduced for EAEU Medical Device Safety and Efficacy Assessments
Recommendation of the Board of the Eurasian Economic Commission No. 14, dated May 21, 2019
Regulators assess and verify the safety, quality, and clinical efficacy of a medical device through a comprehensive review of:
• Complete regulatory registration dossiers;
• Manufacturer site inspection reports;
• Post-market surveillance plans for new devices, or historical adverse event logs for products already in circulation;
• Records of adverse events, product recalls, and subsequent field safety corrective actions (FSCAs);
• Post-marketing clinical follow-up (PMCF) reports.
Experts must employ a stringent risk-oriented methodology during evaluation. The depth, volume, and granularity of the evidentiary materials requested by regulators must remain strictly proportional to the potential risk classification of the device.
8. EAEU Codifies Unified Medical Device Classification Framework
Decision of the Board of the Eurasian Economic Commission No. 62, dated April 16, 2019
Market participants must utilize this standardized classifier when drafting registration dossiers and submitting official documentation to EAEU member state regulators. The decision became effective on May 19, 2019, and remains in force.
9. Harmonized Structural Requirements Established for EAEU Registration Dossiers
Recommendation of the Board of the Eurasian Economic Commission No. 29, dated October 8, 2019, “On Methodological Guidelines for the Content and Structure of Medical Device Registration Dossier Documents”
To initiate expert evaluation and registration, the applicant must submit a complete electronic registration dossier alongside proof of statutory fee payments to the chosen reference state.
The guidelines specify explicit dossier contents. Applicants are legally required to file:
• A formal application for registration and expert evaluation;
• An executed Power of Attorney (PoA) from the manufacturer authorizing local representation;
• Certified copies of manufacturing licenses issued by the country of origin, including all appendices (where available);
• Valid Quality Management System (QMS) certificates of the manufacturer;
• An official Declaration of Conformity to essential safety and performance requirements or equivalent documentation (where available);
• Copies of current Certificates of Free Sale (CFS) or Export Certificates;
• Foreign registration approvals from other global jurisdictions (where available);
• A technical monograph detailing the medical device's scope, clinical indications, and essential baseline characteristics (including labeling and packaging data);
• Engineering and design details (process flowcharts detailing manufacturing phases, packaging workflows, and final release protocols);
• Corporate background data regarding the manufacturer (legal name, commercial activities, registered office, ownership type, and executive leadership);
• Historical commercialization logs if the device has been actively marketed for over two years;
• Adverse clinical event reporting and product recall operations, with an explicitly defined historical tracking timeline;
• A comprehensive compliance matrix listing all international standards met by the medical device;
• Detailed evidence demonstrating conformity to global safety parameters and clinical performance rules;
• Technical specification sheets establishing baseline product requirements;
• Formal laboratory reports covering technical, biocompatibility, and toxicological testing;
• Clinical evaluation reports (CER) validating safety and efficacy, alongside complete risk assessments.
The regulation affirms that clinical data obtained outside EAEU member states can be integrated into the clinical evaluation report to substantiate safety and efficacy, provided the foreign data fully aligns with the device's intended use and clinical indications.
10. EAEU Clarifies Protocols for Interacting with the Medical Device Nomenclature Operator
Recommended Procedure for Interaction Between the Operator of the Medical Device Nomenclature of the Eurasian Economic Union and Legal Entities, Individual Entrepreneurs, and Authorized Bodies of EAEU Member States (Appendix No. 2 to the Protocol of the Seventh Meeting of the Working Group on Coordination of Work on the Creation and Maintenance of the Medical Device Nomenclature of the Eurasian Economic Union No. 1-NMI, Dated July 17, 2019)
To ascertain a device's specific classification or confirm that the current nomenclature lacks a corresponding category, applicants may petition the Nomenclature Operator. The Operator has a statutory 20-day window to review the file and issue a binding determination regarding the presence or absence of the relevant code.
Upon formal confirmation that no suitable category exists, the applicant can request the creation of a new medical device code within the EAEU nomenclature.
The application must include the following supporting documentation:
• A copy of the initial classification determination request filed under the standard nomenclature;
• The exact product name and model designations in English;
• Detailed technical descriptions in both Russian and English highlighting the novel features that mandate a new classification;
• Comprehensive Instructions for Use (IFU) in both official languages.
The Operator routes the application file to the Federal State Budgetary Institution (FSBI) for expert review. This evaluation proceeds under a commercial contract executed between the applicant and the FSBI in accordance with the host member state's national laws where the Operator is registered.
11. Implementation of Track-and-Trace Pilot Program for Wheelchairs
Decree of the Government of the Russian Federation No. 1028, dated August 7, 2019, “On Conducting a Pilot Program within the Russian Federation for Labeling Wheelchairs Classified as Medical Devices with Identification Marks and Monitoring Their Turnover” (together with the “Regulation on Conducting a Pilot Program within the Russian Federation for Labeling Wheelchairs Classified as Medical Devices with Identification Marks and Monitoring Their Turnover”)
The Russian Government mandated a pilot identification program running from September 1, 2019, to June 1, 2021, to track the commercial turnover of medical wheelchairs using secure digital serialization markers.
The designated information system operator, in coordination with the Ministry of Industry and Trade, must draft technical system specifications, data security protocols, and cyber security rules to safeguard information processed during the pilot.
The Government instructed the Ministry of Industry and Trade to secure inter-agency approval and release comprehensive methodological guidelines, implementation timelines, system architectures, and strict information protection frameworks by December 1, 2019.
The enforcement landscape dictates a two-phased roll-out: Phase 1 targets manual wheelchairs (lacking mechanical propulsion), while Phase 2 extends the mandate to motorized or electrically propelled units.
12. Federal Subsidy Framework Approved for High-Tech Medical Device Development
Decree of the Government of the Russian Federation No. 1463, dated November 16, 2019, “On Approval of the Rules for Providing Subsidies from the Federal Budget to Russian Organizations to Financially Support Part of the Costs of Implementing Projects for the Development of Modern Technologies, Organizing Production, and Launching Competitive Medical Devices Based on Them, and on Recognizing Certain Acts of the Government of the Russian Federation as Invalid”
The federal government provides these subsidies to support domestic industrial manufacturers registered in the Russian Federation that are engaged in high-tech research, manufacturing scaling, and commercializing competitive medical devices.
Approved funding offsets specific operational expenditures, including:
• Employee payroll obligations and mandatory state insurance contributions (medical, social, and pension funds);
• Direct material costs excluding VAT and capital expenditures in fixed assets of the manufacturer;
• General overhead expenses capped at 60% of total project costs, excluding business entertainment, leisure travel, or trade show booth rentals;
• Fees paid to third-party contractors for domestic or international project support, capped at 80% of the total subsidy, including foreign clinical trials and international registration costs (excluding VAT).
Recipients cannot use subsidy funds to purchase foreign currency, unless executing transactions strictly compliant with Russian currency laws for importing high-tech equipment, raw materials, or sub-assemblies critical to the project.
The Ministry of Industry and Trade awards these subsidies through a rigorous competitive tender process.
13. Ministry of Health Releases Clarifications on Weighted Average Pricing for State Procurements
Letter of the Ministry of Health of the Russian Federation No. 25-3/I/2-11362, dated November 29, 2019, “On Weighted Average Prices for Medical Devices Subject to Admission Restrictions for the Purpose of Procurement to Meet State and Municipal Needs”
To calculate the initial maximum contract price (NMCK) for single-use PVC medical devices originating from foreign states subject to national procurement restrictions under Decree No. 102, this document provides updated parameters for the statutory localization coefficient (Kl).
The letter details the mathematical formula used to compute localization variables and publishes specific coefficients for 2019 product types (e.g., a Kl of 1.00 for blood transfusion and infusion systems; 0.99 for leukocyte filters with collection bags; and 0.98 for urinary/ostomy pouches).
14. State Expands Approved List of Free Implantable Medical Devices
Government Directive No. 2333-r, dated October 8, 2019, “On Amending Government Directive No. 3053-r, Dated December 31, 2018”
The expanded schedule now incorporates advanced implantable devices distributed under state guarantees, including:
• Bioabsorbable synthetic polymer ligation clips;
• Endoscopic ligation loops;
• MRI-compatible, rate-adaptive, dual-chamber implantable pacemakers;
• MRI-compatible endocardial pacemaker leads.
15. Ministry of Finance Granted Oversight Veto on Medical Procurement Schedules
Decree of the Government of the Russian Federation No. 1306, dated October 10, 2019, “On Amending Paragraph 20 of the Rules for Forming Medical Device Lists”
Draft schedules detailing implantable devices distributed under state guarantee programs, alongside prescription-only items available through social welfare networks, must now secure formal fiscal clearance and approval from the Ministry of Finance.
16. Government Codifies Standardized Spending Caps for Subsidized Medical Allocations
Decree of the Government of the Russian Federation No. 1554, dated November 30, 2019, “On Amending Decree of the Government of the Russian Federation No. 864, Dated December 29, 2004”
As of January 1, 2020, the statutory monthly financial allowance per citizen eligible for state social assistance (including prescription medical devices, pharmaceuticals, and specialized medical nutrition for disabled children) is established at RUB 860.60, calibrated against clinical treatment standards.
17. Roszdravnadzor Issues Compliance Guidelines for Oncology Care Licensing
Letter of Roszdravnadzor No. 01i-2204/19, dated September 10, 2019, “On Compliance with Licensing Requirements in the Provision of Medical Care in Oncology”
The agency update notes that under the federal “Combatting Oncological Diseases” initiative, regional programs aim to modernize over 160 licensed oncology and pathology facilities. All procured hardware and installations must strictly comply with the mandated medical device procurement schedule authorized under Ministry of Health Order No. 56n.
18. Legal Protocols Codified for Distributing Home-Use Palliative Life-Support Systems
Order of the Ministry of Health of the Russian Federation No. 831, dated October 3, 2019, “On Approval of the Departmental Target Program: Development of the Palliative Care System”
Order of the Ministry of Health of the Russian Federation No. 348n, dated May 31, 2019, “On Approval of the List of Medical Devices Designed to Support the Functions of Organs and Systems of the Human Body Provided for Home Use”
Order of the Ministry of Health of the Russian Federation No. 505n, dated July 10, 2019, “On Approval of the Procedure for Transferring Medical Devices Designed to Support the Functions of Organs and Systems of the Human Body from a Medical Organization to a Patient (or Their Legal Representative) for Home Use in the Provision of Palliative Care”
The program allocates federal budget subsidies to co-finance regional initiatives focused on modernizing outpatient and home-based palliative care facilities with vital life-support technologies.
Regulators intend to enhance the accessibility and standard of regional palliative care by reinforcing the material and technical infrastructure of clinics managing patients across outpatient, home, day-hospital, and inpatient settings.
The authorized list of home-use life-support devices includes advanced anesthetic systems, medical inhalers, mechanical ventilators, and infusion pumps.
The medical institution's internal clinical review board must authorize the device transfer within three business days following the submission of the patient’s informed voluntary consent and a home environment suitability checklist. When distributing hardware for long-term respiratory support, the facility must supply a secondary backup ventilator if the patient cannot maintain spontaneous ventilation independently for a duration of 2 to 4 hours.
19. FMBA Enacts Operational Directives for Donor Blood Storage and Logistics
Recommendations on the Execution of Necessary Measures by Entities Engaged in the Turnover of Donor Blood and its Components, Directed at the Implementation of and Compliance with the Rules for Procurement, Storage, Transportation, and Clinical Use of Donor Blood and its Components, Approved by the FMBA of Russia
The operational directives specify rigorous compliance measures for blood product logistics, focusing on:
• Deploying certified medical devices capable of maintaining mandatory temperature configurations;
• Provisioning specialized temperature-logging instruments for any transit duration exceeding 30 minutes.
20. Roszdravnadzor Codifies Federal Enforcement Prevention Program to Curb MedTech Market Violations
Order of Roszdravnadzor No. 507, dated July 8, 2019, “On Approval of the Departmental Program for the Prevention of Violations of Mandatory Requirements in the Exercise of State Quality and Safety Control of Medical Activities, Federal State Supervision over the Turnover of Medicines, and State Control over the Turnover of Medical Devices”
The agency highlights core market infractions, including the breach of statutory limits on interacting with MedTech or pharmaceutical corporate representatives, accepting prohibited corporate gifts or financial considerations, entering into non-compliant prescribing agreements designed to favor specific devices, or receiving promotional commercial samples for patient distribution.
This preventive framework aims to structurally minimize operational infractions across clinical settings while scaling the efficiency of federal healthcare surveillance. Furthermore, it aims to optimize the working conditions of Roszdravnadzor's field inspectorate and incentivize audited entities to strictly adhere to prevailing Life Sciences laws and state safety parameters.
