Authorized Representative
Foreign manufacturers must appoint a local legal entity. Belrosmed becomes your Authorized Representative in Belarus — named on the certificate, handling claims, vigilance and post-market obligations.
2026 intake National & EAEU registration tracks now open
Register your medical products in Belarus without the guesswork
Belrosmed is the Minsk-based regulatory partner for manufacturers worldwide. We act as your legal Authorized Representative, drive the full dossier through the Ministry of Health and the Center for Expertise & Testing in Healthcare — then connect you with distributors who already win state tenders.
- 480+
- Products registered
- 32
- Countries served
- 97%
- First-pass approvals
Dossier · VitaScan V400
Ref. BLM-2026-0412 · Class IIb device- Eligibility & classification
- Dossier compiled (RU/EN)
- Technical & sanitary testing
- MoH expert review
- Registration certificate
EAEU gateway180M+ population
Authorized Rep.Legal entity in Minsk
Trusted by manufacturers & exporters in 32 countries
ISO 13485 dossiersTechnical files & QMS
MoH & RUE CEITDirect filing experience
EAEU-wide reach5 member states
NDA-first intakeIP protected from day 1
Full-service regulatory
Everything between your factory and a Belarusian hospital
One accountable partner for the entire market-entry chain — legal representation, registration, testing, inspection and commercial launch. No handoffs, no surprise invoices.
Registration strategy
We map your product to the right pathway — national Belarusian procedure or the centralized EAEU route — and lock the fastest compliant path before a single fee is paid.
Dossier & translation
Technical file, risk management (ISO 14971), clinical evaluation, labeling and IFU prepared and translated into Russian or Belarusian by medical-grade linguists.
Testing & clinical evaluation
We coordinate technical, sanitary-hygienic and, when required, clinical evaluation in EAEU-accredited laboratories — often satisfied by equivalence and literature for CE/FDA products.
Factory inspection support
Audit readiness for state inspectors: gap assessment against Belarusian requirements, document rehearsal, on-site interpreting and follow-up CAPA management.
Distributor matching
A certificate is not a market. We shortlist vetted importers with hospital coverage and tender history, run introductions, and help you structure exclusivity that actually performs.
How it works
A registration you can actually track
Five phases, one project manager, weekly written status. You always know which document is where — and what happens next.
Week 1–2 Free of charge
Eligibility & strategy
We review your CE/FDA file, determine the Belarusian risk class and rule, and recommend the national or centralized EAEU pathway with a fixed budget and calendar.
1 / 5
Why Belarus
A small market with outsized leverage
Manufacturers often treat Belarus as an afterthought. That is precisely the opportunity: low competition, codified procedures, publicly funded demand — and a dossier that travels across the whole Eurasian Economic Union.
Minsk · HQ
On the ground where decisions are made
Our team sits minutes from the Ministry of Health and the expertise centre. Files are hand-delivered, queries answered the same week, inspections attended in person.
14 yrsIn Belarusian regulatory practice
3 languagesEN · RU · BY correspondence
A door into 180M+ consumers
Belarus is a full member of the Eurasian Economic Union. A compliant EAEU dossier prepared here is reusable across Russia, Kazakhstan, Armenia and Kyrgyzstan.
Predictable, codified rules
Registration is governed by Regulation No. 254 and the EAEU framework, with a statutory ceiling of 150 calendar days. Fewer surprises than most emerging markets.
State-funded procurement
Healthcare is publicly financed and equipment renewal runs through structured tenders — recurring, high-volume orders for registered products.
Light clinical burden
Products already cleared in the EU or US are, in most cases, exempt from local clinical trials. Equivalence and literature routes are accepted.
0Population with universal coverage
0EAEU market reachable from Minsk
0Statutory registration ceiling
0Certificate validity, renewable
Distributor network
Registration opens the door. We introduce you to the people already inside.
Belrosmed maintains a working relationship with more than 70 Belarusian importers, hospital suppliers and tender specialists across diagnostics, surgery, rehabilitation, dental and IVD. We match on category fit, hospital coverage and proven tender wins — never on who pays us the most.
- 70+Vetted distributors & importers
- 12Product categories covered
- 100%Reference-checked partners
- 21 daysAverage time to first meeting
Client outcomes
Manufacturers who stopped waiting on paperwork
From Class I consumables to implantables and IVD platforms — here is what regulatory and commercial leaders say after going through the process with us.
“We had been told Belarus would take two years. Belrosmed filed in seven weeks and we had the certificate in month six — with the labeling and IFU already approved in Russian. Their query responses were faster than our own internal reviews.”
“What sold us was that they were honest about what we did not need. They cut three tests from the plan and saved us close to €14,000 before we had even signed.”
“The distributor introductions were worth the whole engagement. Three qualified importers in a month, and the one we picked won a Ministry tender in our first quarter on the market.”
“As a Chinese manufacturer we struggled with legalization and notarization. Belrosmed handled the entire document chain and acted as our Authorized Representative — one contract, no intermediaries.”
“Weekly written status reports, a named project manager, and a fixed price that never moved. That is rare in regulatory consulting anywhere in the world.”
Ready to see your own product on this page? Send one datasheet and we will return a Belarusian classification, timeline and fixed quote — free.Start my free review
Transparent pricing
Fixed fees, quoted before we start
No hourly billing, no scope creep. State duties and accredited laboratory fees are passed through at cost with original invoices attached.
Essentials
For Class I and IIa non-sterile devices with a clean CE or FDA file and a single product group.
€3,900
from · per product group
Start with Essentials- Classification & pathway memo
- Dossier compilation and filing
- Authorized Representative, 12 months
- Labeling & IFU translation (RU)
- State-fee administration
- Email support, 2 business days
Most chosen
Full Registration
The complete national or EAEU registration for Class IIa–III devices, IVD platforms and equipment.
€7,500
from · per product group
Book a scoping call- Everything in Essentials
- Authorized Representative for 5 years
- Testing strategy & accredited-lab coordination
- Clinical evaluation / equivalence dossier
- Factory inspection preparation & interpreting
- Named project manager, weekly reporting
- Unlimited deficiency responses
- Change notifications for 24 months
Market Entry Partner
For manufacturers who want revenue in Belarus, not just a certificate on the wall.
Custom
retainer + success fee
Design my entry plan- Everything in Full Registration
- Portfolio-wide registration roadmap
- Shortlist & introduction to 3–5 distributors
- State tender strategy and bid documentation
- Pricing, reimbursement & KOL guidance
- Quarterly market review with your team
- Priority hotline, same-day response
Assessment
Pre-submission gap analysis of your CTD against EAEU and Belarusian expectations.
€4,600
from · per dossier
Request assessment- CTD Module 1–5 gap review
- MAH & representation structuring
- GMP certificate assessment
- Regulatory strategy memo
- Fee & timeline forecast
- Email support, 2 business days
Most chosen
Full Marketing Authorization
End-to-end registration of medicinal products under the EAEU procedure via Belarus.
€14,800
from · per dossier
Book a scoping call- Everything in Assessment
- Module 1 preparation in Russian
- Labelling, SmPC & PIL localisation
- Sample import and laboratory control
- GMP inspection coordination
- Expert Council representation
- Pharmacovigilance QPPV setup
- Variation support for 24 months
Lifecycle Partner
Ongoing local presence for portfolios with multiple molecules and renewals.
Custom
annual retainer
Design my entry plan- Everything in Full MA
- Local MAH representation
- Renewals & re-registration calendar
- Distributor and wholesaler matching
- Tender & reimbursement dossier support
- Quarterly portfolio review
- Priority hotline, same-day response
Every engagement starts under NDA. Fees exclude state duties (from USD 394 initial examination) and accredited laboratory testing, which are invoiced at cost. Payment is staged against milestones — you never pay for a phase before it begins.
Questions
Answers before the first invoice
The details manufacturers ask us most often. Anything missing? A regulatory lead — not a salesperson — replies within one business day.
No. You keep full ownership of the registration, but Belarusian law requires a foreign manufacturer to appoint a local Authorized Representative responsible for claims, vigilance and communication with the authorities. Belrosmed performs that role under a simple service agreement — no joint venture, no equity, no distributor lock-in.
The statutory ceiling for the national procedure is 150 calendar days including your responses to deficiency letters, and the Ministry of Health then issues the certificate within 15–30 days. In practice we see 4–6 months for Class I–IIa devices and 6–9 months for equipment, IVD platforms and Class III products where testing or an inspection is required.
It depends on your commercial horizon. The national certificate is faster and cheaper and is valid for five years in Belarus. The centralized EAEU registration takes longer but produces a certificate recognised across member states, which is the right choice if Russia or Kazakhstan is on your roadmap. We model both in the free assessment and recommend one in writing.
Usually not. Devices already approved in the EU or the US are in most cases exempt, and compliance can be demonstrated through clinical evaluation, equivalence and published literature. Implantables and certain high-risk products are the main exceptions — we flag this before you commit any budget.
An inspection of the batch-release site may be requested at first registration. Class I non-sterile products with a limited number of SKUs, and products already registered in both the EU and the US, are frequently exempt. When an inspection does happen, we prepare your team, attend on site and interpret throughout — and the results do not expire.
The dossier can largely be submitted in English, but labeling, instructions for use and selected sections must be provided in Russian or Belarusian. All translation, notarization and legalization is handled in-house by medical-grade linguists, so terminology stays consistent with your technical file.
Yes — it is the reason most manufacturers come to us. Once registration is underway we shortlist importers by category fit, hospital coverage and tender history, arrange introductions and help you structure exclusivity with performance milestones. We do not take commission from distributors, so the shortlist stays neutral.
Registrations are living assets. We monitor regulatory changes, file change notifications when you modify design, labeling or manufacturing sites, handle vigilance reporting, and start the renewal process three months before expiry so your market access never lapses.
Free eligibility review
Send us one product. We’ll send back a plan.
Share a datasheet or CE certificate and we will return the Belarusian classification, the recommended pathway, an honest timeline and a fixed quote — at no cost and with nothing to sign.
- Written reply within 1 business day
- NDA signed before any file is shared
- Free classification & pathway opinion
Request received
Thank you. A regulatory lead will review your product and reply within one business day with the classification and next steps. Check your inbox for our mutual NDA.