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VIENA MEDICAL
Projects·MoH BY · Since 2018

8 years of dialogue
on reforming the system.

Systemic letters to the Ministry of Health, the antimonopoly authority, the State Control Committee, the State Security Committee and the President of the Republic of Belarus — on demonopolising the medical-device market, switching to procurement of medical investigations, registration of devices, licensing of medical activities and Point-of-Care Testing.

10+
years
2018–2026
11
letters
on substance
21
agencies
addressees
6
topics
systemic directions
Demonopolisation · Procurement of investigations · POCT
Systemic work
Demonopolisation · Procurement of investigations · POCT
9 letters · 6 directions

What we proposed to the system

  • Switching from procurement of equipment and reagents to procurement of medical investigations
  • Admitting analog devices to «closed» laboratory systems
  • Reforming registration of medical devices and after-sales service
  • Outsourcing of laboratory services and home-based diagnostics
  • POCT as a standalone regulatory category
  • Professional dialogue between the regulator and innovative projects
Timeline

From the first “Action plan” to POCT.
Newest first.

2026 → 2016
2026
2 letters
2026Meetings with MoH · 2026

POCT equipment: adapting the regulatory requirements

↳ Ministry of Health · I. Abelskaya

A proposal to make Point-of-Care Testing a separate regulatory category and to exempt closed-cycle devices from the rules designed for stationary laboratories.

POCTRegulationAccess
Key points · 5▾
  1. A closed analytical cycle removes the contamination risks that today’s lab requirements were designed for.
  2. POCT does not need zoning, special premises or a separate licence — the device is used by the physician at the patient’s bedside.
  3. Regulatory precedents: the FDA cleared home-use POCT PCR (LUCIRA); the WHO recommends GeneXpert; the EU, the UK and Australia have dedicated POCT frameworks.
  4. GeneXpert has been operated safely in Belarus for more than 12 years — a practical argument for treating POCT as its own class.
  5. We propose a single regulatory document: criteria for the closed cycle, registration requirements, quality control, disposal of consumables.
2026Meetings with MoH · 2026

Systemic issues in medical-activity licensing

↳ Ministry of Health · I. Abelskaya

The MyLab case (Medex-Lab LLC): the licence was suspended on 9 October 2025 without prior dialogue, even though a Ministry of Health commission later confirmed compliance with the licensing requirements.

LicensingMyLabDialogue with the regulator
Key points · 5▾
  1. 9 October 2025 — licence suspended pending an inspection; operations stopped immediately.
  2. 20–26 November 2025 — the MoH commission confirms compliance; the remarks are formal (documentation, instrument verification) and pose no risk to patients.
  3. 2 December 2025 — the MoH clarification to the tax authority contradicts MoH Decree No. 123 of 2016, according to which blood collection is a stand-alone medical service.
  4. Affected groups of citizens: people with disabilities, oncology patients, children, the elderly and residents of remote areas — those for whom MyLab made genetic testing available at home.
  5. The systemic issue: there is no professional dialogue between the MoH and innovative medical services before irreversible administrative procedures are launched.
2025
1 letter
16.04.2025No outgoing No.

Formalistic antitrust control and the move to procurement of medical investigations

↳ President of the Republic of Belarus · Chair of the State Control Committee

Following the 2024 amendments to the public-procurement law, the antimonopoly authority applies the “no-affiliation tick-box” mechanically, ignoring obvious signs of related parties while penalising bona-fide suppliers.

AntitrustMARTProcurement of investigationsBudget
Key points · 5▾
  1. In auction No. auc0002276259 Viena Medical was technically late ticking the no-affiliation box within three days after winning — the company was placed on the list of unreliable suppliers despite the price cut and many years of clean work.
  2. Lot 52 in auc0002281421: five participants with obvious affiliation flags (identical addresses, near-identical submission times) — all formally declared they were unrelated, and the antimonopoly authority accepted the self-declaration as sufficient.
  3. Spending on laboratory reagents in 2024 reached BYN 437.5 million (18 % of all healthcare procurement); the average price reduction was 11 %, with an annual budget overspend of more than BYN 50 million.
  4. The share of tenders with real bidding between Siemens, Roche, Abbott and Beckman Coulter over the entire history of independent Belarus is 0 %. Procurement is driven by equipment specifications, not by the demand for investigations.
  5. Proposal: switch to procuring medical investigations end-to-end (equipment + reagents + controls + service), permit outsourcing and parallel imports, and allow the no-affiliation declaration to be signed simultaneously with the contract.
2024
1 letter
12.12.2024Outgoing No. 148

Procurement inefficiency at Medtekhnika Gomel

↳ MoH · MART · MoI Anti-Corruption Bureau · Gomel Regional Executive Committee · Belmedtekhnika

Analysis of Medtekhnika Gomel for H1 2024 shows the lowest price reduction among district branches and signs of a systematically uncompetitive environment.

Public procurementGomelCompetitionData analysis
Key points · 5▾
  1. Tender MT 810-24 for pipette tips: the procurement commission demanded a “confirmation that the tip is single-use” — a request that makes no sense and de facto restricted the bidder pool.
  2. Average price reduction at Medtekhnika Gomel was 16 % vs. 20 % at the Republican branch of Belmedtekhnika; 65 % of H1 2024 contracts saw a reduction below 10 %.
  3. Procurement of automated immunochemistry and biochemistry analysers — about BYN 3 million, while other healthcare facilities obtain comparable equipment essentially free of charge as part of reagent contracts.
  4. The annual tender for NanoChecker 710 reagents is run without admitting analogs; the cost per test is USD 8–9 while alternatives registered in Belarus exist at USD 3–4.
  5. Request for systemic intervention and a check of staff actions against Articles 3 and 9 of the Law on Public Service.
2023
2 letters
19.04.2023Outgoing No. 69

On-site inspection of Jiangsu Huida (China)

↳ RUE “CEIZ” · M. Zlotnikova

MoH Decree No. 37 of 7 March 2023 exempts from on-site inspection any manufacturer holding an FDA or CE clearance. Jiangsu Huida is registered in Belarus, holds FDA clearance and has been supplied since 2020 with no complaints.

Device registrationCEIZHuidaParallel import
Key points · 5▾
  1. Between 2020 and 2023 about EUR 1 million worth of Jiangsu Huida products were supplied to Belarusian healthcare facilities through public tenders.
  2. Competitors in those tenders are German manufacturers; excluding Huida would translate into a budget overrun of at least USD 500 000.
  3. The demand for an on-site inspection contradicts MoH Decree No. 37 of 7 March 2023 and EU Regulations 2017/745 and 2017/746.
  4. If the registration certificate is suspended, the collected materials will be submitted to the Prosecutor General’s Office for an assessment of CEIZ staff actions.
  5. Systemic context: since 2017 we have submitted policy proposals to the MoH, KGB, Presidential Administration and Prosecutor General’s Office — this case is part of that ongoing work.
03.01.2023Outgoing No. 1

Action plan 2.0: five years on

↳ Ministry of Health · D. Pinevich

Five years after the first “Action plan”, an updated set of proposals: simplified registration of medical devices, demonopolisation of public procurement, parallel imports, outsourcing of laboratory services and home-based diagnostics.

ReformAction planOutsourcing
Key points · 5▾
  1. Device registration: verify the authenticity of FDA/CE certificates instead of demanding legalised copies; consider the experience of Armenia and Kyrgyzstan; an alternative to the CEIZ monopoly is a small unit at the MoH or at the standardisation agency.
  2. Demonopolising procurement: a systematic admission of registered analogs to “closed” systems with supplying equipment from another manufacturer as an in-kind discount.
  3. Parallel imports and a reform of technical service: remove the CEIZ monopoly on servicing and place responsibility with the healthcare facilities themselves.
  4. Outsourcing of laboratory services — a pilot project at a single facility with Synevo, Invitro, Synlab; the model already works in Kazakhstan.
  5. Develop the legal framework for at-home medical services and for self-funded activities of state laboratories.
2022
1 letter
15.06.2022Outgoing No. ___

Analogs of “closed” systems — part 2

↳ MoH · D. Pinevich · MART · Belmedtekhnika

A systematic analysis of tenders following the first letter: healthcare facilities routinely refuse to admit analogs for i-Chroma, Easy Reader, FREND, NanoChecker and other closed systems, turning the procurement into single-bidder events.

AnalogsClosed systemsTenders
Key points · 5▾
  1. Standard refusal language: “we will only consider tests for the analyser already in place” — effectively cementing the monopoly of the official distributor.
  2. Closed systems (i-Chroma, Easy Reader, FREND, NanoChecker) make the “adaptation requirement” unsatisfiable by definition — no other tests exist for them.
  3. A table of dozens of auctions on goszakupki.by and butb.by with the same pattern of refusing analogs.
  4. The analysers themselves cost less than BYN 1 000, while the tests for them are purchased for tens of thousands of BYN every year; an alternative is to provide a new analyser as an in-kind discount.
  5. A request for the MoH, together with MART and Belmedtekhnika, to develop a unified mechanism for admitting analogs.
2021
1 letter
10.11.2021Outgoing No. 179

Analogs of “closed” systems — part 1

↳ MoH · B. Androsyuk · MART

The first systemic letter on analogs: reagents for closed systems are purchased without a competitive environment, in violation of clause 4 of Article 21 of the Public Procurement Law; 13 requests and replies from healthcare facilities are attached.

AnalogsPublic procurement lawPreanalytics
Key points · 5▾
  1. MoH board decree No. 14.4 of 25.07.2018 instructed the system to switch to procuring “reagents together with analytical systems” — in practice the mechanism is not implemented.
  2. Using brand names and manufacturer names in the terms of reference is an abuse of paragraph 4 of clause 4 of Article 21 of the Public Procurement Law.
  3. Rapid-screening equipment is inexpensive, but the monopoly price on the tests is economically more attractive to the closed-system supplier.
  4. 13 requests to Belarusian healthcare facilities (Kopyl, Kobrin, Pinsk, Nesvizh, Stolin, Myadel, Vileyka, Slutsk, Soligorsk, Kletsk, etc.) — all refused to admit analogs.
  5. Request to design a system for admitting registered analog equipment with reagents — to widen the bidder pool and reduce budget spending.
2018
1 letter
13.09.2018Outgoing No. 73

Action plan 1.0 (the original)

↳ State Security Committee · to whom it may concern

The first systemic letter, which laid the groundwork for everything that followed: five problems in the healthcare system and the corresponding proposals.

FoundationAction planKGBSystemic reform
Key points · 5▾
  1. Problem 1 — formal device registration at CEIZ: a barrier for “unwanted” products while at the same time registering products that have not passed FDA/EU/RU clearance.
  2. Problem 2 — no real control during the in-use phase: complaints are not filed and the republican quality programme is purely formal.
  3. Problem 3 — terms of reference written for a specific device lead to single-bidder events and monopoly prices; the solution is to procure investigations rather than equipment and reagents separately.
  4. Problem 4 — loss of staff qualifications and the absence of international experience; English-language training, engagement of international consultancies, use of the Vietnamese experience (agreement of 27.06.2017).
  5. Problem 5 — no foundation for digitalisation: reworking Order No. 1123 on the preanalytical phase, building a national catalogue of investigations on top of LOINC and requiring open integration protocols for laboratory information systems.
2017
1 letter
15.02.2017Outgoing No. 3

Quality of Chinese vacuum tubes and an audit of the registration dossiers

↳ Minister of Health · V. Malashko · MoH · E. Bogdan · CEIZ

In Russia, the top four manufacturers (Greiner, BD, Sarstedt) hold about 80 % of the blood-collection market; in Belarus only ~10 %, while 90 % of healthcare facilities use Chinese tubes that are not registered in Russia and not sold in Western Europe or the US. Systemic defects: sodium-citrate evaporation before expiry, vacuum underfill below ISO 6710, aerosol risk and R-Sterile labelling without re-registration. About 70 % of lab errors come from preanalytics; a tube costs ~1.5 % of a routine assay. We request a CEIZ field inspection and an audit of the registration dossiers of Hunan Liuyang, Weihai Hongyu and Ningbo Greetmed.

PreanalyticsQualityCEIZISO 11137China
Key points · 5▾
  1. Market structure: Russia — 80 % Greiner/BD/Sarstedt; Belarus — ~10 %; 90 % of Belarusian healthcare facilities use Chinese tubes that are not registered in Russia and not sold in Western Europe or the US.
  2. Documented defects: 100 % of cases show sodium-citrate evaporation before expiry; vacuum underfill below the GOST ISO 6710 ±10 % limit; incompatible needles and holders; risk of splashing potentially infected material; aerosol effect on cap opening.
  3. About 70 % of laboratory errors are linked to preanalytics; the cost of even the most expensive tube is roughly 1.5 % of a routine assay. Buying expensive reagents while drawing blood with syringes or unsterile tubes is an unconscious act.
  4. Request to CEIZ: a field inspection of Hunan Liuyang Medical, Weihai Hongyu and Ningbo Greetmed products plus an audit of their registration dossiers for apostilled gamma-sterilisation certificates (ANSI/AAM/ISO 11137) and compliance with Directive 98/79/EC.
  5. Request to the MoH: form an independent expert group (with possible participation of private-laboratory experts and Russian MoH staff) to agree unified requirements for vacuum systems and let a Viena Medical representative address the Republican Lab-Medicine Conference.
2016
1 letter
27.05.2016Outgoing No. 04/16

Preanalytics: a review of the standard TOR for vacuum systems

↳ Presidential Administration · A. Kosinets · MoH · E. Bogdan

A point-by-point review of Belmedtekhnika’s standard TOR for vacuum tubes: 16 requirements are either generic or unfalsifiable, which lets Chinese products without FDA, RU registration or finishing gamma sterilisation win tenders with margins below 0.2 % over Greiner Bio-One. The tube cost is about 3 % of a test, so saving on it is illusory. A baseline package of mandatory and optional preanalytical requirements is proposed, based on ISO 6710, Directive 98/79/EC and CLSI H01-A6.

PreanalyticsStandard TORISO 6710Public procurement
Key points · 5▾
  1. All 16 items of Belmedtekhnika’s standard TOR are either applicable to any vendor or unfalsifiable — the document does not capture the real characteristics of the products being procured.
  2. 2016 tenders (Gomel Medtekhnika, Minsk Diagnostic Centre, City Gynecological Hospital): Hunan Liuyang wins over Greiner Bio-One by less than 0.2 % while lacking FDA clearance, ISO 11137 sterilisation, RU registration and safety mechanisms.
  3. Even the most expensive blood-collection system costs about 3 % of a routine assay; a poor specimen leads to repeat sampling, damaged probes on analysers and incorrect diagnoses.
  4. A baseline of mandatory requirements is proposed: dosed vacuum ±10 % (ISO 6710), ISO 9001/13485 certificates, ISO 6710 colour coding, blood-repellent caps and screw caps for transport to centralised facilities.
  5. Parallel work with Greiner Bio-One under the Belarus–Germany executive training programme — negotiations on special pricing for the Belarusian healthcare system.

Where the systemic work began

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