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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
12
letters
on substance
23
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
3 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.
2026Analytical memo · 2026

Absurd enforcement practices by the MoH licensing office

↳ Ministry of Health · I. Abelskaya

A memo documenting five concrete cases of over-regulation, abuse of power and systemic contradictions inside the MoH licensing office in lab diagnostics — with direct links to the public licence registry and to existing MoH decrees. Part 1 of the MyLab (Medex-Lab LLC) package.

Full text: absurd practices and the draft amendments to the licensing law

LicensingMyLabUltra viresLab diagnostics
Key points · 5▾
  1. Case 1 · Anti-scientific wording in the licence. Sample-collection points of laboratory networks receive licences that read “general-clinical (non-invasive) methods of investigation (biological material collection)”. Venous and capillary draws are invasive by definition (the skin barrier is broken). Inspectors can later fine the centre for performing invasive procedures under a “non-invasive” licence. Example: license.gov.by/onelicense/188148.
  2. Case 2 · Illegal individual restrictions written into the licence. Some licences explicitly say: “Collection of biological material is prohibited for persons who are not patients of the company’s physicians.” No statute forbids a citizen from giving samples on their own initiative — this rider is a direct abuse of power and forces patients into a paid visit to that centre’s doctor. Example: license.gov.by/onelicense/162014.
  3. Case 3 · Conflating collection with the test itself. Inspectors refuse to recognise the split between preanalytics (collection) and analytics (running the test). A clinic with a treatment-room is required to obtain a full laboratory-diagnostics licence merely because it draws blood and ships it under contract to a centralised lab. Pushed to its limit: a gynaecologist would formally need a histology licence to take a biopsy — clearly absurd, and a blow to the global outsourcing model.
  4. Case 4 · Disproportionate punishment, suspension up front. Medex-Lab LLC: the licence was suspended 26 days BEFORE the MoH commission actually visited the site. The commission then confirmed no threat to patients and full compliance — yet officials ignored the report, refused to reinstate the licence and instead launched tax-authority requests looking for new grounds to shut the project down. Total paralysis of the business in lieu of a time-bound prescription to fix a paperwork issue — huge losses, disrupted patient care and an enormous corruption surface.
  5. Case 5 · The MoH contradicting itself. In response to tax and court requests the licensing office issues clarifications that say “sample collection is part of the test, not a separate service”. At the same time MoH Decree No. 123 (2016), still in force, explicitly states: “blood collection is a stand-alone medical service with autonomous, complete meaning.” Every state polyclinic’s receipt lists “venous blood collection” as a separate line at a separate price — meaning the licensing office is denying the universal accounting and tariff practice of the country’s entire health system.
2026Draft legal act · 2026

Draft amendments to Law No. 213-Z on licensing: a package of 9 blocks

↳ Ministry of Health · Ministry of Economy · Parliamentary dialogue

A package of concrete textual amendments to the Law of the Republic of Belarus of 14 October 2022 No. 213-Z “On licensing”, each block precisely citing the section, chapter and article to be modified. Nine blocks: legalising the outsourcing model in lab diagnostics, walk-in access to testing, softening licence suspensions, banning expansive interpretation, mandatory public clarifications, scientifically accurate licence wording, prohibition of individual restrictions in the licence text, legalising at-home / mobile collection, and the primacy of MoH clinical protocols. Part 2 of the MyLab package.

Full text: absurd practices and the draft amendments to the licensing law

Law 213-ZReformOutsourcingLab diagnosticsPreanalytics
Key points · 9▾
  1. Block 1 · Legalising the outsourcing model in lab diagnostics (Section II, medical activity). Codify the split of laboratory diagnostics into a preanalytical stage (collection, labelling, storage, transport of biological material) and an analytical stage (the test itself). A nursing/medical-manipulations licence is sufficient grounds to collect any biological material. When the material is handed over to a partner laboratory under a civil-law contract, the collecting party does not need a separate profile licence for laboratory diagnostics.
  2. Block 2 · Walk-in access to testing without a mandatory consultation (Section II, medical activity). Codify: biomaterial collection follows from the citizen’s own request, with no mandatory referral or consultation with a physician of the same medical centre. Exception — cases where a statute expressly requires an examination for a specific type of investigation. Removes the artificial paid barrier to self-initiated testing.
  3. Block 3 · Softer suspension procedure (Section I, Chapter 7, Article 38). Suspension of a licence shall not be applied if the violations can be cured without halting the activity and do not pose an immediate threat to life or health. In such cases the licensing authority confines itself to a prescription to cure the violations within a reasonable deadline. The hard measure is reserved for direct patient risk.
  4. Block 4 · Ban on expansive interpretation (Section I, Article 6 “Principles of licensing”). Add the principle: licensing authorities and other inspectors must not apply expansive interpretation of legal acts or licensing requirements that tightens conditions or impairs the rights of applicants and licensees. Closes the loophole for “local interpretations” against business.
  5. Block 5 · Mandatory dialogue and safe-harbour for clarifications (Section I, Article 12). Licensing authorities must: (a) consult professional associations before changing the approach to assessing requirements; (b) publish official consolidated clarifications. A licensee cannot be punished (fine, suspension) for actions taken in strict accordance with such published clarifications.
  6. Block 6 · Scientifically accurate wording in licences (Section I, Articles 12 and 32). Names of works/services in the licence and in the Unified Licence Register must strictly follow the approved medical nomenclature and retain their objective scientific and technological meaning. The use of mutually exclusive concepts or wording that distorts the nature of a medical procedure is forbidden (e.g. classifying invasive blood collection as a “non-invasive method”).
  7. Block 7 · Direct ban on individual restrictions in the licence text (Section I, Article 32). When granting or amending a licence the licensing authority is prohibited from imposing individual restrictive conditions in the form of notes, footnotes or special marks. Entries that limit the set of persons entitled to receive services, or introduce barriers not provided for by law, are not allowed.
  8. Block 8 · Legalising mobile / at-home delivery of services (Section II / Section I, Article 32). Authorise the provision of licensed medical services outside the address stated in the licence: collection and transport of biological material at the patient’s place of residence, including by mobile teams. Conditions: the licensee has equipped premises at the declared address and complies with MoH requirements on transport and portable equipment. Solves access for people with disabilities, oncology patients, the elderly, children and remote communities.
  9. Block 9 · Primacy of MoH clinical protocols in enforcement (Section I, Article 12). When assessing compliance with licensing requirements, inspectors must rely on the clinical protocols, instructions and orders approved by the Ministry of Health (including Order No. 1123, which legalises the off-lab preanalytical stage). No sanctions may be applied to a licensee whose actions strictly follow these MoH profile acts.
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

OpenFor regulators and media

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