Russian medical procurement splits further under 44-FZ and 223-FZ.
What changed for hospitals and clinics in 2026.
In 2026, the head of procurement at a state clinical hospital and the owner of a private clinic down the block buy the exact same ultrasound machine under formally different rules. Yet these rules are quietly converging. The state has expanded the window of flexibility for budgetary institutions within 44-FZ while simultaneously drawing private clinics operating under the Compulsory Health Insurance (CHI) system closer to the logic of state oversight that previously applied only to public sector entities.
For suppliers of medical devices and pharmaceuticals, this means the old market division into «public» (44-FZ) and «free» (223-FZ) no longer captures the full reality. Forked paths have emerged within each law, and a unified national regime framework has hung over both since 2025. Let us break down what is already in force today and what still remains only a draft proposal.
Who Procures Medical Devices and Pharmaceuticals and on What Grounds
State Clinical Hospitals (GKB) most often operate as State Budgetary Healthcare Institutions (GBUZ). The bulk of their procurement is financed through subsidies for state assignments and is conducted strictly under Federal Law No. 44-FZ. This entails electronic procedures, small business quotas, justification of every price, and rigid alignment with the procurement plan-schedule.
Autonomous Healthcare Institutions (AUZ) procure under Federal Law No. 223-FZ and determine their own procurement methods via their internal Procurement Regulations. The law explicitly names tenders, auctions, requests for quotations, and requests for proposals, while also allowing the buyer to write any other method into their Regulations at their discretion. In practice, clinics often embed «competitive negotiations» in their Regulations, enabling them to clarify technical parameters of complex equipment prior to submitting final price offers, something an auction under 44-FZ does not allow.
Private clinics, including those operating within the CHI system, are not bound by either 44-FZ or 223-FZ at all; they purchase equipment and consumables based on the Civil Code.
There is also an intermediate case. Article 15 of 44-FZ permits a budgetary institution to procure under the rules of 223-FZ if the source of funding falls into one of three categories: grants and donations, funds earned as an executing contractor under someone else’s contract, or revenue from income-generating activities. The condition is straightforward: the legal act transitioning the entity to 223-FZ (the Procurement Regulations) must be adopted and published in the Unified Information System (UIS) prior to the start of the calendar year.
Here lies a detail that is frequently overlooked. The law explicitly excludes funds received for rendering and paying for medical care under CHI from the third category. Out-of-pocket paid services provided to patients outside the CHI program grant a GBUZ the right to transition to 223-FZ. Money from the CHI fund gives no such right; therefore, a hospital cannot procure a tomography scanner under the flexible rules of 223-FZ simply because it paid for it using CHI tariff funds.
Regarding the entry of private clinics into the registry of CHI medical organizations, the current edition of Federal Law No. 326-FZ remains notification-based. A clinic submits a notification to the Territorial CHI Fund (TFOMS) by September 1 of the year preceding the operational year, and the fund cannot legally refuse entry into the registry. This rule has not changed yet, although the Ministry of Health has drafted stricter selection criteria.
What Changed in Procedures by 2026
The request for quotations has become the primary tool for small procurements without volume caps. Until the end of 2025, temporary relief measures were in effect. As of January 1, 2026, Federal Law No. 494-FZ of 26.12.2024 permanently abolished the annual volume restriction on electronic requests for quotations (ERQ). Previously, the annual total for such procurements could not exceed 20% of the buyer’s total annual procurement volume (SGOZ) or 100 million rubles. The threshold per single procurement remains at up to 10 million rubles per contract, with the government retaining the right to raise it for specific categories of medical devices. For a state hospital, this means an out-of-stock item can be resolved in a matter of days rather than spending a month on an auction, and this can be done repeatedly throughout the year.
The National Regime was consolidated into a single document and renamed. Effective January 1, 2025, Decree of the Government of the RF No. 1875 of 23.12.2024 replaced fragmented regulations on domestic product preferences with a unified three-tier scheme. The first tier (Annex No. 1) imposes an outright ban on foreign goods across specific positions. The second tier (Annex No. 2), covering roughly 430 items, primarily medical devices and pharmaceuticals from the Vital and Essential Drugs (VED) list, operates on the mechanism industry professionals call the «third excess» rule (третий лишний): if at least one qualifying bid offering Russian or Eurasian Economic Union (EAEU) origin is submitted, all foreign bids are rejected. The third tier provides a 15% price preference for Russian goods during bid evaluation when both Russian and foreign offers compete.
Decree No. 1875 covers procurement under both 44-FZ and 223-FZ. There is one notable exception: retail pharmacy organizations procuring pharmaceuticals and medical devices for resale under 223-FZ are exempt from bans, restrictions, and price preferences. However, if a hospital or clinic buys medical devices for its own clinical operations under Procurement Regulations, it falls under the «third excess» rule on equal footing with 44-FZ buyers.
The pricing methodology for medical devices is mandated only for 44-FZ. Order of the Ministry of Health of Russia No. 450n of 15.05.2020 establishes unified rules for determining the initial (maximum) contract price for medical devices for state and municipal needs: using the comparable market price method, the tariff method, or the weighted average price based on registry contract data, depending on the item type. A buyer under 223-FZ is not bound by this methodology. They establish price justification procedures independently within their own Procurement Regulations. This offers greater flexibility, and the burden of proof during audits rests squarely on how convincingly those Regulations are drafted.
Specifying a specific trademark is permitted under both laws, each with caveats. Under 44-FZ, the description of the procurement object generally must not contain a specific trademark if doing so unreasonably restricts competition, and any trademark mention requires the clause «or equivalent.» Federal Antimonopoly Service (FAS) Russia Letter No. GR/48883/25 of 26.05.2025 explicitly grants an exception: when procuring consumables for existing equipment, the buyer may specify the precise trademark of the consumable if required by the technical documentation of the equipment. Under 223-FZ, a similar logic applies: trademarks are permissible in procurement descriptions if there is no other way to accurately describe the required specifications and it does not create unjustified barriers to entry. The principle is shared across both laws; the difference is that under 223-FZ, the buyer justifies the choice internally and to regulators using custom rules, whereas under 44-FZ, it relies on a single federal template.
Abnormally low bids (anti-dumping) are regulated by federal law only in 44-FZ. If the initial (maximum) contract price exceeds 15 million rubles and the winner offers a price drop of 25% or more, Article 37 of 44-FZ requires contract performance security 1.5 times higher than the standard amount. The floor for such security is fixed separately at 10% of the total contract price. For smaller initial prices, the winner can, instead of providing increased security, prove good standing by presenting three successfully performed contracts without penalties over the past three years, with at least one contract valued at no less than 20% of the new procurement’s initial price.
For pharmaceuticals on the VED list, anti-dumping rules do not apply at all if the price reduction does not exceed 25% relative to the drug’s registered maximum selling price. The logic is clear: VED items already have a state price ceiling, making additional anti-dumping checks redundant. Under 223-FZ, federal law mandates no such mechanism. Buyers may choose to incorporate similar logic into their Procurement Regulations voluntarily, or leave procurement of medical devices and drugs without formal anti-dumping protections.
The VAT rate increase to 22% requires different solutions across the two laws. Federal Law No. 425-FZ of 28.11.2025 raised the standard VAT rate from 20% to 22% as of January 1, 2026 without a transition period. Under 44-FZ, essential terms of a contract cannot be altered, and contract price is classified as essential. The Ministry of Finance maintains that the specific VAT rate itself is not an essential term and can be adjusted via a supplementary agreement. Under 223-FZ, the buyer can proactively outline price adjustment mechanisms in their Procurement Regulations for tax rate changes, enabling recalculation without supplier disputes.
The equipment purchase limit for private CHI clinics has been raised. The territorial program of state guarantees for 2026 increased the ceiling for purchasing medical equipment using CHI funds from 100,000 to 400,000 rubles per unit, provided it matches the official equipment standard for the care profile. This allows clinics to upgrade mid-tier machinery without resorting to loans or leasing.
Oversight regarding the targeted use of these funds remains strict. The Supreme Court of the Russian Federation, in Ruling No. 302-ES26-857 of 12.03.2026, upheld a Territorial CHI Fund’s decision ruling the purchase of a video colonoscope worth 990,000 rubles as non-targeted spending. The clinic had purchased it above the cost threshold and outside its approved equipment standards.
Comparison of Procedures by Buyer Type
| Parameter | State Hospital under 44-FZ (GBUZ) | Autonomous Institution under 223-FZ or GBUZ under Art. 15 | Private Clinic (CHI & Civil Code) |
|---|---|---|---|
| Supplier selection method | Auction, tender, ERQ up to 10M RUB | Method per internal Procurement Regulations | Direct contract, free selection |
| Price justification | Method under Order No. 450n (medical devices) | Methodology per internal Procurement Regulations | Market price, CHI tariff cap |
| Trademark in description | Requires «or equivalent,» except consumables for existing equipment (Letter No. GR/48883/25) | Permissible with documented necessity | Not regulated by a separate procurement law |
| National regime | Decree No. 1875 («third excess» rule applies) | Decree No. 1875 applies, except retail pharmacy sales | Does not apply directly |
| Anti-dumping for 25%+ price cuts | Mandatory under Art. 37 of 44-FZ | Governed by internal Procurement Regulations | Unregulated |
| Equipment cap | Limited only by SGOZ and the budget | Limited by the institution’s own funds | Up to 400,000 RUB per unit (CHI funds) |
| Regulatory oversight | FAS, Treasury, Accounts Chamber | FAS via complaints or planned audits | TFOMS, insurance companies, Prosecutor’s Office |
Action Plan
Verify which portion of the state hospital budget falls under Article 15. Separate funding sources into three streams: grants and donations, performance of third-party contracts, and commercial revenue outside CHI. Ensure the Procurement Regulations covering these streams are formally adopted and posted in the UIS before the start of the year, since switching to 223-FZ mid-year is not an option.
Cross-reference your medical device and drug portfolio with the annexes of Decree No. 1875. Identify which items face a total ban, which trigger the «third excess» rule, and which qualify only for a price preference. For items listed under Annex No. 2, request confirmation from the State Information System of Industry (GISP) well in advance: without confirmed Russian origin, the bid is rejected automatically.
Prepare supplementary agreements for contracts transitioning through the VAT increase (20% to 22%). For 44-FZ contracts, formalize the position that the tax rate is not an essential term, and agree on price adjustments with suppliers before shipment after January 1, 2026. For 223-FZ, check whether your Procurement Regulations already cover statutory tax changes, and add such a clause if they do not.
For private CHI clinics, fix the 400,000-ruble cap and equipment standard in your process. Before acquiring equipment, cross-check the item against the official equipment standard for your medical care profile. Fund any purchase above the cap or outside the standard exclusively from the clinic’s own resources, keeping it separate from the CHI tariff, to avoid repeating the outcome of Ruling No. 302-ES26-857.
Track the Ministry of Health’s draft criteria for CHI private clinic selection. Entry into the CHI registry currently remains notification-based. In parallel, stricter criteria are being drafted, covering license tenure, the volume of care rendered, and Roszdravnadzor violations over the preceding two years. Compile documentation on these points in advance to protect your standing in the CHI system once the rules change.
Formally, 44-FZ and 223-FZ remain distinct laws built on different philosophies. In practice, both are now held to the same national regime, the same VAT rate, and an increasingly similar standard of control over targeted spending. The procedural gap between «public» and «private» procurement in medicine persists. The gap in what is expected of the result is closing fast.
Regulatory Framework:
1. Ruling of the Supreme Court of the RF No. 302-ES26-857 of 12.03.2026
2. Federal Law No. 44-FZ of 05.04.2013 «On the Contract System in the Field of Procurement of Goods, Works, and Services for State and Municipal Needs»
3. Federal Law No. 223-FZ of 18.07.2011 «On Procurement of Goods, Works, and Services by Certain Types of Legal Entities»
4. Federal Law No. 326-FZ of 29.11.2010 «On Compulsory Health Insurance in the Russian Federation»
5. Federal Law No. 494-FZ of 26.12.2024 «On Amendments to Certain Legislative Acts of the Russian Federation»
6. Article 37 of Federal Law No. 44-FZ (anti-dumping measures)
7. Federal Law No. 425-FZ of 28.11.2025 (raising the VAT rate to 22%)
8. Decree of the Government of the RF No. 1875 of 23.12.2024 «On Measures for Providing National Regime in the Procurement of Goods, Works, and Services for State and Municipal Needs, and Procurement of Goods, Works, and Services by Certain Types of Legal Entities»
9. Order of the Ministry of Health of Russia No. 450n of 15.05.2020 «On Approval of the Procedure for Determining the Initial (Maximum) Contract Price… for Medical Devices»
10. Letter of FAS Russia No. GR/48883/25 of 26.05.2025