Ministry of Health · structured requirements

🇧🇾 Belarus IVD regulatory data

Explore the IVD requirements currently available for Belarus, organized by topic and linked to official sources.

2 facts1 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration in Belarus

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Belarus approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Belarus (4 records)

Prior approval / evidence record

China-registered devices admitted to Belarusian public procurement before national registration (Resolution 51/2021 as amended 2024)

reliance.china-nmpa-bilateral-programme

Fact-level verified

Statement: Since 7 July 2024, Ministry of Health Resolution No. 51 of 19 May 2021, as described in the Belarusian Embassy procurement notice, allows unregistered medical devices produced by residents of the People's Republic of China and in circulation in China to be offered in Belarusian public-procurement procedures. The bidder must include copies of the Chinese export certificate and the Chinese device registration certificate, a valid contract with the Centre for Expertise and Testing in Health Care for pre-registration technical work, and an undertaking to hold a Belarusian registration certificate by the delivery date.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: Chinese medical-device registration certificate and export certificate for the eligible China-produced device
Target Jurisdiction Id: belarus
China Classes In Scope: China-produced, China-registered devices covered by the procurement notice; equivalence of a Class I filing to the required registration certificate is not established
Edge Type: Procurement Admission
Market Access Strength: facilitated
Regulatory Layer: Public Procurement
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Device must be produced by a PRC resident and be in circulation in the PRC
Bid must include copies of the export certificate for medical products and the device registration certificate (NMPA), a current ЦЭИЗ contract for pre-registration technical work, and a written undertaking to provide the Belarusian registration certificate no later than the delivery date
Belarusian state registration is still required before delivery; the measure is a procurement-timing facilitation, not recognition

Effective from 2024-07-07

Source passage: С 07.07.2024 в процедурах государственных закупок в Республике Беларусь разрешено предлагать незарегистрированные медицинские изделия, произведенные в Китайской Народной Республике и находящиеся в обращении на территории Китайской Народной Республики. Несмотря на вышеуказанное, к моменту поставки медицинское изделие должно быть зарегистрировано участником государственной закупки в соответствующем порядке. ... копии сертификата на экспорт медицинской продукции и сертификата о регистрации медицинского изделия;

BelarusEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: Technical and QMS documentation can be reused, but Belarus runs its own state registration and publishes no recognition route for a CE certificate.
Timeline Savings: None published

Resolution of the Council of Ministers No. 211 of 28 April 2026 — state registration of medical devices, preliminary technical works capped at 90 calendar days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence only, with no recognition route and no published reduction.
Timeline Savings: None published

Resolution of the Council of Ministers No. 211 of 28 April 2026 — state registration of medical devices, preliminary technical works capped at 90 calendar days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: For foreign-made devices the national dossier must include a document on registration and/or authorisation to market the device in the country of manufacture (registration certificate, free-sale certificate, declaration of conformity or a dated screenshot of the regulator's official website), legalised and translated; an NMPA registration certificate is that document for China-made devices. Under the EAEU route the same evidence is an 'if available' item. Neither route abridges the Belarusian or EAEU expertise on the basis of NMPA approval.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: belarus
China Classes In Scope: All classes under the national registration route (Minhealth Resolution 55, Appendix 1, item 2.3) and the EAEU route (Decision 46 dossier item 10)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

National route: legalisation/apostille and notarised Belarusian/Russian translation unless an international treaty provides otherwise
EAEU route: item 10 'при наличии'
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2015-04-23

Source passage: (held fact) документ о регистрации и/или разрешении к применению медицинского изделия в стране производителя (регистрационное удостоверение, сертификат свободной продажи, декларация о соответствии, скриншот официального сайта регулятора с датой)

Related structured datasets

Classification systems · 1 record

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

Id

belarus:medical-device

Jurisdiction Id

belarus

Domains

medical-device
ivd

Name

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

Classes

Id
1
Label
Class 1
Normalized Risk Level
low
Id
2a
Label
Class 2a
Normalized Risk Level
medium
Id
2b
Label
Class 2b
Normalized Risk Level
high
Id
3
Label
Class 3
Normalized Risk Level
highest

Regulator

Ministry of Health

Official Domains

minzdrav.gov.by
rceth.by

Source Status

official-source-verified

Source Title

Minzdrav Order No. 1324 of 16.12.2014, Appendix 2 (classification of medical products by potential risk)

Source Url

https://www.rceth.by/Documents/3mz3prN132420141216.rtf

Verified On

2026-08-25

Source Supports

class-axis
classification-rules
ivd-class-axis

Notes

Classification considers duration of use, invasiveness, contact with the body, method of introduction, use for vital organs/systems, and use of energy sources; per-class wording covers IVDs as well.
Where more than one rule applies the higher class applies; accessories are not classified separately; calibrators and control materials take the class of the device they control.
National practice also references the EAEU classification rules (EEC Board Decision No. 173 of 22.12.2015), e.g. clinical-trial durations per EAEU classes 1/2a/2b/3; the four-class national and EAEU schemes align.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Belarus registration →

Country

Belarus

Jurisdiction Id

belarus

Country Code

BY

Flag

🇧🇾

Regulator

Ministry of Health of the Republic of Belarus

Regulator Abbrev

Ministry of Health

Region

europe

Tier

3

Risk Classification

4-class (1, 2a, 2b, 3) — EAEU classification

Classes

Id
national-registration
Class Name
National registration (all classes)
Pathway
Ministry of Health registration after the preliminary technical works
Official Timeline
Min
90
Max
150
Unit
days
Verification Status
official-verified
Official Source
Title
Resolution of the Council of Ministers No. 211 of 28 April 2026 — state registration of medical devices, preliminary technical works capped at 90 calendar days
Url
https://pravo.by/upload/docs/op/C22600211_1777496400.pdf
Effective Date
2026-05-01
Accessed Date
2026-08-29
Realistic Timeline
Min
5
Max
9
Unit
months
Notes
Point 3: the complex of preliminary technical works, which is the substantive evaluation, may not exceed 90 calendar days and can be extended to at most 150 only by agreement between the applicant and the Centre for Expertise and Testing in Healthcare
The Centre is expressly forbidden to widen the scope of those works, which is what previously drove the period out to 300 days under the repealed 2008 regime
The clock is route-wide: Resolution 211 varies the dossier by risk class but not the period
Tail steps: point 10 gives the Ministry 5 working days to notify its decision, and point 12 gives 5 working days to issue the certificate once the state duty is confirmed paid
Clinical Trial Required
No
Local Testing Required
Yes
Gmp Required
Yes

Key Requirements

Local Authorized Representative (for foreign manufacturers)
Preliminary technical works are organised by the Centre for Expertise and Testing in Healthcare and capped at 90 calendar days, extendable to 150 by agreement
Registration certificate issued within 5 working days after payment of the state duty is confirmed
Resolution No. 211 of 28 Apr 2026 repealed the 2008 regime; Resolution No. 378 of 27 Jul 2026 amends it on terminology only and leaves the periods unchanged

Prior Approvals

Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
Technical and QMS documentation can be reused, but Belarus runs its own state registration and publishes no recognition route for a CE certificate.
Timeline Savings
None published
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Usable as supporting technical evidence only, with no recognition route and no published reduction.
Timeline Savings
None published

Local Rep Required

Yes

Local Rep Name

Belarus Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

Indefinite — point 12 of Resolution 211 makes the national certificate open-ended

Last Updated

2026-08-29

Verification Status

official-verified

Official Sources

Title
Resolution of the Council of Ministers No. 211 of 28 April 2026 — state registration of medical devices, preliminary technical works capped at 90 calendar days
Url
https://pravo.by/upload/docs/op/C22600211_1777496400.pdf
Effective Date
2026-05-01
Accessed Date
2026-08-29

Reviewed On

2026-08-29

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Belarus Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Duration
90-150 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Ministry of Health issues Belarus market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Belarus fees →

Jurisdiction Id

belarus

Country

Belarus

Country Code

BY

Authority

Ministry of Health / RCETH

Low Risk Local

Min: 0
Max: 0
Currency: BYN
Per Product: Yes

High Risk Local

Min: 0
Max: 0
Currency: BYN
Per Product: Yes

Details

Id
current-official-fee-status
Item
National registration state duty and expert charges
Currency
BYN
Amount Local
0
Amount Local Formatted
10 base units (BYN 450 in 2026) + expert fees
Frequency
Check before submission
Notes
The current national procedure requires payment of the state duty after the registration decision; the Tax Code rate is 10 base units and the official 2026 base value is BYN 45.
Amount Status
formula-or-dynamic
Verification Status
official-source-only
Source Url
https://www.alta.ru/tamdoc/26bl0211/
Source Title
Belarus 2026 national medical-device registration procedure, Council of Ministers Resolution 211
Source Effective Date
2026-04-28
Verified On
2026-08-25

Notes

The current national procedure requires payment of the state duty after the registration decision; the Tax Code rate is 10 base units and the official 2026 base value is BYN 45.
Under the unified list of administrative procedures (CM Resolution 548): EAEU-route registration (9.3.6) is subject to state duty; national dossier changes (9.3.3) and EAEU-route dossier changes (9.3.7) are free; advertising approval (8.14.2) is a paid service.
RCETH expert-evaluation charges are separate and route-dependent, so BYN 450 is not an all-in registration total.

Last Updated

2026-08-25

Verification Status

official-source-only

Official Sources

Title
Belarus 2026 national medical-device registration procedure, Council of Ministers Resolution 211
Url
https://www.alta.ru/tamdoc/26bl0211/
Effective Date
2026-04-28
Accessed Date
2026-08-25
Title
Belarus tax authority: 2026 base value is BYN 45 under Resolution 651
Url
https://nalog.gov.by/inspectorates/reference/imns-minsk-region/clarifications/34365
Effective Date
2026-01-01
Accessed Date
2026-08-25
Title
RUP CEIZ Q&A: state duty of 10 base units for registration of a medical product
Url
https://rceth.by/ru/Reception/QuestionAnswers/16
Accessed Date
2026-08-25
Title
Belarus unified list of administrative procedures (CM Resolution 548): fee status per procedure
Url
https://www.rceth.by/Documents/2sm2poN54820210924.pdf
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

formula-or-dynamic

Range Available

No

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Belarus certifications →

Slug

belarus

Market

Belarus

Confidence

low

Schemes

Id
eaeu-medical-device-safety-evidence
Name
EAEU medical-device safety evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
National route (CM Resolution 211 p. 3; MoH Resolution 55 items 1.13-1.14, 2.4, 2.14): primary and specialized document expertise for all devices; biological-effect testing (research/tests to assess biological action) for domestic and foreign devices; technical testing only for domestically produced devices; sanitary-hygienic testing protocols in the dossier; clinical trials assigned by the Ministry; QMS certificate (ISO 13485-type) required as dossier evidence for foreign producers.
Source Urls
https://www.rceth.by/ru/Documents/Med?orderby=name&dir=desc
Source Binding
candidate
Id
encryption-notification
Name
Encryption notification
Category
Import Conformity
Status
Mandatory If Feature
Object
Cryptographic Product
Source Urls
https://eec.eaeunion.org/upload/medialibrary/750/Guidance-on-the-Eurasian-Economic-Union-Trade-Regulation-2020.pdf
Source Binding
candidate

Official Sources

Authority
Eurasian Economic Commission
Topic
radio, encryption and import-regulation registries
Url
https://eec.eaeunion.org/upload/medialibrary/750/Guidance-on-the-Eurasian-Economic-Union-Trade-Regulation-2020.pdf
Authority
Eurasian Economic Commission
Topic
medical-device measuring-instrument requirements
Url
https://eec.eaeunion.org/upload/medialibrary/353/Agreement-on-common-principles-and-rules-for-the-circulation-of-medical-devices.pdf
Authority
RCETH
Topic
CM Resolution 211 and MoH Resolution 55 registration testing requirements
Url
https://www.rceth.by/Documents/3mz2poN5520220411.pdf
Authority
RCETH
Topic
national acts list for medical device registration
Url
https://www.rceth.by/ru/Documents/Med?orderby=name&dir=desc

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Need to apply Belarus's requirements to a product?

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