Ministry of Health · Europe

Belarus medical device regulatory resources

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23,666 registration records9 free resources23/25 requirements coveredAug 2026 fees reviewed

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Medical device registration database

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Medical device regulation news

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Government registration fees

Review current Belarus and EAEU medical-device fee evidence and official tariff availability.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare the statutory preliminary-works period with realistic approval times.

Structured regulatory requirements

Explore all 45 source-linked facts →

23 of 25 research dimensions currently covered · 16 official sources · latest verification 2026-08-29

Market entry

D01

Authority & regime

Verified

Competent authority for state registration: Ministry of Health of the Republic of Belarus (Министерство здравоохранения) is the authority that carries out state registration of medical products and issues the registration certificate…
Expert and registry operator organization: RUP 'Center for Expertise and Testing in Healthcare' (РУП «Центр экспертиз и испытаний в здравоохранении», rceth.by) organizes the preliminary technical works (expertise, inspection, testin…

3 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Current legal framework: Core acts in force on 2026 08 25: Healthcare Law № 2435 XII of 18.06.1993 (as amended 08.07.2024), Art. 391; CM Resolution № 211 of 28.04.2026 (national registration, repeals CM Res. 1269/2…

1 source-linked fact

Checked 2026-08-25

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D03

Device definition & scope

Verified

Medical product definition: 'Medical products (медицинские изделия, изделия медицинского назначения, медицинская техника)' = any instruments, apparatus, appliances, equipment, materials and other products used for med…
Borderline rule vs medicinal products: A product is a medical product only if its functional purpose is not achieved by pharmacological, immunological, genetic or metabolic action on the human body (such action may, however, be…

4 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

National risk classes 1, 2a, 2b and 3 (Ministry of Health Order No. 1324 of 16.12.2014, Appendix 2).: Class 1, Class 2a, Class 2b, Class 3

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Dual registration routes: Belarus operates two parallel market admission routes: national state registration by the Ministry of Health (CM Resolution 211/2026, admin procedure 9.3.1) and registration within the EAEU…
Events requiring state registration: State registration is required for: devices first created in Belarus; foreign made devices first offered in Belarus; devices analogous to registered ones but made by another producer; previ…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

EAEU common registration recognized in Belarus: A device registered under the EAEU common registration procedure is admitted to production, sale and medical use in Belarus without a separate national registration; Belarus also acts as EA…
Foreign registration document as dossier evidence: For foreign made devices the national dossier must include a document on registration and/or authorization to market the device in the country of manufacture (registration certificate, free…

3 source-linked facts

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Applicant on the national route: The applicant for national registration (reregistration, dossier changes) is: the producer; a legal entity or individual entrepreneur within the same association (объединение) as the produc…
Authorized representative of the producer: 'Authorized representative of the producer of medical products' = a legal entity, individual entrepreneur registered in Belarus, or a representative office of a foreign organization, empowe…

3 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Import ban on unregistered and non-conforming devices: Import into Belarus, production, sale and medical use are prohibited for: substandard, counterfeit and falsified devices; expired devices; unregistered devices (unless legislation or EAEU l…
Circulation subjects must be Belarus-registered: 'Circulation subjects' of medical products are legal entities and individual entrepreneurs registered in Belarus and representative offices of foreign organizations that conduct testing, ex…

2 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Documents submitted to the Ministry: After a positive RUP CEIZ conclusion from the preliminary technical works, the applicant submits to the Ministry of Health: (1) an application and (2) the RUP CEIZ conformity conclusion; fo…
Foreign-producer dossier items: For foreign produced devices the dossier (Resolution 55, Appendix 1, section 2) includes: application; producer's information letter; registration/market authorization document from the cou…

3 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Current application form: The current application for state registration (admin procedure 9.3.1) is the form approved under Minhealth Resolution № 42 of 12.05.2022; it requires, among other data: applicant/producer/…
Registration certificate form: The registration certificate (регистрационное удостоверение) is issued on a security blank in the form annexed to CM Resolution 211; it states the applicant, the device per nomenclature cla…

2 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

IFU and labeling language: The IFU (инструкция по применению) or operation manual (руководство по эксплуатации) and other foreign language dossier documents must be accompanied by a translation into Belarusian or Rus…

1 source-linked fact

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Production inspection requirement and triggers: National registration is preceded by production inspection by RUP CEIZ, required when: the device is made on a first declared production site (except non sterile foreign class 1); the site…
QMS certificate as dossier evidence: A QMS conformity certificate for the producer (and production site, where applicable) must be included in the registration dossier; the registration dossier must contain production inspecti…

2 source-linked facts

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

EAEU medical-device safety evidence: Electrical safety
Encryption notification: Import CoC / PVoC

2 maintained overlays

Checked 2026-08-29

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D14

Fees

Unresolved

National registration state duty and expert charges: 10 base units (BYN 450 in 2026) + expert fees

1 maintained fee line · 1 related fact

Checked 2026-08-25

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D15

Review clocks

Verified

National registration (all classes) · Ministry of Health registration after the preliminary technical works: 90-150 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Registration certificate validity: The national registration certificate is indefinite ('Регистрационное удостоверение является бессрочным'). Reregistration applies only where a certificate issued before 25 July 2022 expires…

1 source-linked fact

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Dossier change cases and deadline: Changes to the registration dossier are made for defined events (new name without changing properties; new medical indication; applicant/producer reorganization, name or address change; pro…
Events requiring new registration: A new state registration (not a variation) is required where an already registered device is produced by another producer or where a new production site is added for a registered device.

3 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

State Register of medical devices: The State Register of Medical Products (Государственный реестр изделий медицинского назначения и медицинской техники) is a public state information resource owned by the Ministry of Health…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical trials in state organizations only: Clinical trials of medical products are conducted only in state healthcare organizations, after laboratory and other tests confirming safety; participation is voluntary with written informe…
Trial duration by risk class: Minimum/maximum clinical trial durations: class 1 — at least 10 and at most 30 calendar days; class 2a — 35 to 70 calendar days; classes 2b and 3 — a period sufficient to establish the corr…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Limited-quantity registration route: Devices supplied in limited quantity may be registered via a dedicated route (procedure 9.3.5) where they are: supplied to state healthcare organizations for international health programs;…
Permit for unregistered devices; personal-use exemption: The Ministry of Health may issue a permit for the sale and/or medical use of unregistered medical products; devices imported by an individual for personal use are exempt from registration.…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

National post-market monitoring system: Post market monitoring on the national route operates through the CM 177 incident system: RUP CEIZ collects and analyzes adverse event (incident) information from circulation subjects, user…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Incident notification and report deadlines: Circulation subjects must notify RUP CEIZ of an adverse event (incident) using the prescribed form (извещение) within 20 calendar days of the event; where there is a serious threat to user…
Consequence of failing to report incidents: Failure of the producer (or its authorized representative) to report an adverse event (incident) to RUP CEIZ, or breach of the prescribed procedure/deadlines, is a ground for the Ministry o…

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Withdrawal, return and destruction: Substandard, falsified and expired devices must be withdrawn from circulation, returned to the producer (or its authorized representative) or destroyed, by decision of their owner or of the…
EAEU recall information exchange: RUP CEIZ maintains a database of substandard and falsified devices identified in Belarus and exchanges information on them with the competent authorities of EAEU member states and other sta…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Advertising approval and restrictions: Advertising of medical products is prohibited without the advertiser holding Minhealth approval (согласование), which is an administrative procedure (8.14.2: 15 days, 1 month where expertis…

1 source-linked fact

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Dispute commission and refusal grounds: The Ministry of Health's commission on medical products handles applicants' disagreements with RUP CEIZ conformity conclusions and product qualification questions. Refusal of registration (…

1 source-linked fact

Checked 2026-08-25

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