Frequently Asked Questions about Registration of medical devices and medicines in Belarus
- In our FAQ page, you can find comprehensive information about the registration process for medical devices, pharmaceuticals, IDV devices and products in Belarus, including details on required documentation, timelines, fees, and regulatory requirements.
- Our goal is to alleviate any uncertainties surrounding the registration of medical devices in Belarus, allowing clients to navigate the process more effectively. By offering clear information, we strive to streamline the registration process and facilitate efficient and compliant registration for medical devices, guaranteeing that our clients meet all necessary legal and safety standards for their products in the Belarusian market.
FAQ. How much does it cost to register medical devices and to find a reliable distributor in Belarus?
FAQ. How much does it cost to register medical devices and to find a reliable distributor in Belarus?
Navigating a new healthcare market requires local expertise. At Belrosmed, we provide end-to-end regulatory and commercial support to ensure your market entry is fast, compliant, and profitable.
Why global manufacturers partner with us:
Why global manufacturers partner with us:
- Strategic Market Entry
- Top-Tier Distribution: We identify, vet, and secure long-term contracts with financially stable importers and distributors.
- Direct Network: We build trusted relationships with end-users, including hospitals, clinics, key opinion leaders (KOLs), and medical universities.
- Accelerated Regulatory Compliance
- Fast-Track Registration: Complete your medical device registration in just 4–5 months (for EU MDR certified products) or 6–7 months (for devices with national export certificates).
- Turnkey Dossier Management: Full preparation of labels, Instructions for Use (IFU), and Technical Information (TI) in Russian/Belarusian.
- Cost Efficiency: 25% discount on professional translation and notarization of your technical dossier.
- Brand Growth & Marketing
- High-Impact Promotion: We organize specialized webinars, seminars, and medical exhibition booths.
- Digital & Influence Marketing: We launch targeted ad campaigns and collaborate with medical influencers to build a powerful brand image for your products.
Our Services and Fees
Maximise your market presence in Belarus with expert medical consulting and strategic distribution partnerships.
Authorised Representative Contract (Medical Consulting)
Maximise your market presence in Belarus with expert medical consulting and strategic distribution partnerships.
Authorised Representative Contract (Medical Consulting)
- Fee: €500 (One-time payment)
- Focus: Full regulatory compliance and representation.
- Fee: €900 / month (Minimum 3 months; price negotiable)
- Focus: Identifying, vetting, and securing long-term contracts with reliable local distributors.
One Product Registration Service - please contact office
The cost of translation and legalisation in Belarus are not included. Inspection of the production site is not carried out, in the case of a simplified registration procedure (When documented by EU MDR certificate).
The cost of translation and legalisation in Belarus are not included. Inspection of the production site is not carried out, in the case of a simplified registration procedure (When documented by EU MDR certificate).
Securing your registration certificate is the most critical step to unlocking the Belarusian healthcare market. Here is how Belrosmed helps your business grow:
Guaranteed Quality & Safety
Guaranteed Quality & Safety
- What it means: Official state registration validates the premium quality of your medical equipment.
- The process: We guide your products through rigorous local laboratory testing to ensure 100% compliance with national standards. [1]
- What it means: Expand your sales pipeline immediately.
- The process: Registration grants you unhindered access to state tenders, public procurement, and high-value contracts with top distributors.
- What it means: Protect your margins and lower operational costs.
- The process: A valid registration certificate is a mandatory prerequisite for unlocking local tax privileges and exemptions.
State registration is a mandatory compliance process required to legally manufacture, import, sell, and use medical equipment and devices in the Republic of Belarus.
The procedure officially verifies three critical pillars:
The procedure officially verifies three critical pillars:
- Safety for human use.
- Premium quality of the product.
- Clinical effectiveness in accordance with local regulations.
State registration is mandatory for medical equipment and products entering the Belarusian market.
Your product must be registered if it falls under any of these 4 categories:
Any product used for diagnostics, treatment, and rehabilitation. This includes high-tech equipment and daily medical consumables.
Your product must be registered if it falls under any of these 4 categories:
- New Imports: Foreign products entering Belarus for the first time.
- New Local Products: Devices manufactured in Belarus for the first time.
- New Indications: Existing registered devices expanding to new medical uses.
- New Manufacturers: Full analogs or generics of already registered devices.
Any product used for diagnostics, treatment, and rehabilitation. This includes high-tech equipment and daily medical consumables.
- All Medical Devices must be registered with the Belarus MOH. Foreign manufacturers intending to import Medical Devices in Belarus must appoint an Authorized Representative.
- All Medical Devices must be registered with the Belarus MOH. Foreign manufacturers intending to import Medical Devices in Belarus must appoint an Authorized Representative.
Authorised Representative Service in Belarus by Belrosmed will be a valuable asset for medical device manufacturers seeking to establish a presence in the country, finding reliable distributor and ensure compliance with local regulations, reduce registration time by almost half!
Foreign manufacturers intending to import medical devices in Belarus must appoint an Authorized Representative who is also responsible for the registration. In August 2022, the Eurasian Commission proposed an extension to the transition period to switch from the national regulatory frameworks to the Eurasian Union regulation enforcement.
Belarus STATE Fee (USD) for the registration of medical devices and products in Belarus
512,40 - State fee for primary examination of documents.
2.136,17 - State fee for carrying out preliminary technical works prior to state registration.
6.800*-** - Visit of two expert auditors (2 days inspection + 2 days on the road).
2.500 - Sanitary and hygienic tests.
145 - State fee for registration.
TOTAL: 12.093,57 - without EU MDR
TOTAL: 5.293,57 - with EU MDR
The cost of translation and legalisation in Belarus are not included
* Inspection of the production site is not carried out, in the case of a simplified registration procedure (When documented by a EU MDR).
** Travel expenses are additionally paid (medical insurance, visa processing, travel to the inspection site and back (including travel to / from Minsk airport, travel
from the airport of arrival to the place of residence and back, travel from the place of residence to the inspected site and back), accommodation); services of an interpreter (s) during the entire period of the inspection, as well as translation into Russian of the necessary documents.
512,40 - State fee for primary examination of documents.
2.136,17 - State fee for carrying out preliminary technical works prior to state registration.
6.800*-** - Visit of two expert auditors (2 days inspection + 2 days on the road).
2.500 - Sanitary and hygienic tests.
145 - State fee for registration.
TOTAL: 12.093,57 - without EU MDR
TOTAL: 5.293,57 - with EU MDR
The cost of translation and legalisation in Belarus are not included
* Inspection of the production site is not carried out, in the case of a simplified registration procedure (When documented by a EU MDR).
** Travel expenses are additionally paid (medical insurance, visa processing, travel to the inspection site and back (including travel to / from Minsk airport, travel
from the airport of arrival to the place of residence and back, travel from the place of residence to the inspected site and back), accommodation); services of an interpreter (s) during the entire period of the inspection, as well as translation into Russian of the necessary documents.
- 3 to 8 months* according to the national procedure in the CEIZ ("CENTER FOR EXAMINATIONS AND TESTS IN HEALTH SERVICE") of the Ministry of Health of Belarus.
- 15 to 18 months* under the EAEU procedure (minimum for 2 countries)
The Republic of Belarus has a "Simplified Registration System" for medical devices and equipment that have EU MDR certificates.
Within the framework of this registration procedure, only examination of documents is carried out: no testing is carried out, no inspection of production is carried out, even if the product belongs to a high risk class. The procedure is much faster in terms of time and reduces the costs required to enter the market of the Republic of Belarus.
Within the framework of this registration procedure, only examination of documents is carried out: no testing is carried out, no inspection of production is carried out, even if the product belongs to a high risk class. The procedure is much faster in terms of time and reduces the costs required to enter the market of the Republic of Belarus.
To calculate the cost of registration it is necessary to determine:
- The number of registration certificates (RC) after analysing the documents provided from the customer (1 RC = 1 Contract). In most cases, we sign one contract with a manufacturer to register one medical device.
- Determine the cost of work of the consulting company
- Determine the cost of work of the authorised body (CEIZ of the Ministry of Health of the Republic of Belarus)
- Determine the cost of testing in laboratories and clinical bases
- Determine the cost of state duties
When ordering 10 or more Registration Certificates, BELROSMED offers a discount and the possibility of concluding one contract for registration of all products.
Registration certificates obtained under the national procedure in the Republic of Belarus will continue to be valid until their expiration date: 5 years and unlimited (upon re-registration)
Yes. National registration requires the appointment of an Authorized Representative of a non-resident manufacturer on the territory of the Republic of Belarus as the organization accepting claims. The applicant for registration may be a company producing medical devices or its authorized representative acting on the basis of a power of attorney. It is preferable for the manufacturer to be the holder of the Registration Certificate. In this case, the manufacturer can control business relations with a distributor or an authorized seller in Belarus.
The Cost of Medical registration in Belarus
The cost of registration of medical devices and equipment in Belarus is a critical consideration for manufacturers looking to enter the country's healthcare market. Belarus has a strict registration process governed by the Ministry of Health, and the associated fees can impact the financial viability of bringing medical products to the country.
The registration cost varies depending on the classification of the medical device, with Class III devices incurring the highest fees. Manufacturers must also account for additional expenses such as document translation, product testing, and engaging local representatives or agencies to facilitate the registration process. These cumulative costs can significantly impact the overall investment required to bring medical devices to Belarus.
The registration cost varies depending on the classification of the medical device, with Class III devices incurring the highest fees. Manufacturers must also account for additional expenses such as document translation, product testing, and engaging local representatives or agencies to facilitate the registration process. These cumulative costs can significantly impact the overall investment required to bring medical devices to Belarus.
It's crucial for manufacturers to thoroughly research and understand the registration fees and associated expenses before initiating the process. By budgeting and planning accordingly, companies can ensure they are financially prepared for the registration journey.
Despite the expenses, gaining access to the Belarusian market can be financially rewarding for medical device manufacturers. The country's healthcare sector is experiencing rapid modernization, presenting lucrative opportunities for innovative medical solutions. Additionally, once a product is registered, the potential for growth and profitability in Belarus can outweigh the initial costs.
In summary, while the cost of registration for medical devices and equipment in Belarus can be considerable, it's crucial for manufacturers to view it as an investment in accessing a promising market. Understanding the expenses involved and planning strategically can help companies navigate the registration process while capitalizing on the opportunities presented by Belarus' evolving healthcare landscape.
Despite the expenses, gaining access to the Belarusian market can be financially rewarding for medical device manufacturers. The country's healthcare sector is experiencing rapid modernization, presenting lucrative opportunities for innovative medical solutions. Additionally, once a product is registered, the potential for growth and profitability in Belarus can outweigh the initial costs.
In summary, while the cost of registration for medical devices and equipment in Belarus can be considerable, it's crucial for manufacturers to view it as an investment in accessing a promising market. Understanding the expenses involved and planning strategically can help companies navigate the registration process while capitalizing on the opportunities presented by Belarus' evolving healthcare landscape.
BELROSMED registration+ services
BELROSMED registration+ services
BELROSMED as an Authorized Trade Representative connects you with end consumers, distributors, conformity assessment, government agencies, provides post-marketing oversight.
BELROSMED offers expert support in the registration of medical devices, medical equipment in Belarus, Russia, EEU, CE. We have been providing comprehensive support since 1994.
For more than 20 years BELROSMED has been successfully helping manufacturers from Europe and China to find business partners, wholesalers, importers, distributors both in Belarus, Russia.
BELROSMED specialises in import-export, distribution projects in Belarus, Russia of medical devices, equipment, disposables, health products, healthy foods, dietary supplements to the end consumers.
Belrosmed registration benefits
BELROSMED experience in registration
Our approach is based on 20 years experience working for manufacturing companies nationally - internationally in medical, veterinary, dietary supplements, fine food industries. BELROSMED specialist have experience working both with auditors and as auditors.
Quick start of registration
Ready to start today. Always holding capacity volume, while being very flexible in both terms and process of work. In touch with you 24/7.
Reliable and official
BELROSMED works in accordance with up-to-date laws, standards, thanks to access to constantly updated documents databases. You entrust us with your product, we minimize your risks in medical device registration.
Our approach is based on 20 years experience working for manufacturing companies nationally - internationally in medical, veterinary, dietary supplements, fine food industries. BELROSMED specialist have experience working both with auditors and as auditors.
Quick start of registration
Ready to start today. Always holding capacity volume, while being very flexible in both terms and process of work. In touch with you 24/7.
Reliable and official
BELROSMED works in accordance with up-to-date laws, standards, thanks to access to constantly updated documents databases. You entrust us with your product, we minimize your risks in medical device registration.
Expert support in registration
BELROSMED offers expert 24/7 support for medical devices registration under the Republic of Belarus procedures.
We save your budget
BELROSMED is your one-stop solution for cost-effective and quality services! By choosing us, you can streamline your processes and save your company's budget. Our comprehensive range of registration services ensures that you receive top-notch solutions from a single, reliable provider.
Narrow specialisation
BELROSMED is an expert in medical devices, pharmaceutics, food products registration, import-export, promotion and distribution with 25 years of practical experience.
Fast regirstration results
BELROSMED offers expert 24/7 support for medical devices registration under the Republic of Belarus procedures.
We save your budget
BELROSMED is your one-stop solution for cost-effective and quality services! By choosing us, you can streamline your processes and save your company's budget. Our comprehensive range of registration services ensures that you receive top-notch solutions from a single, reliable provider.
Narrow specialisation
BELROSMED is an expert in medical devices, pharmaceutics, food products registration, import-export, promotion and distribution with 25 years of practical experience.
Fast regirstration results
BELROSMED guarantees a successful registration dossier initial expert appraisal within 15-30 days after we receive the necessary documents from the manufacturer.
Authorised Representative Service
If you are a manufacturer of medical devices looking to expand your business in Belarus, then utilising an Authorised Representative Service can be a crucial step in ensuring compliance with local regulations. Conducting, supporting, advising your medical project at all stages of registration - obtaining Registration Certificate. BELROSMED provides professional services for new registration, renewal, modification, safety, quality management of medical devices in Belarus.
Belrosmed authorised representative according to Belarusian legislation represents your interests in conformity assessment bodies, state institutions, helps to speed up the development of documents for registration dossier, registration process itself
The Belarusian government requires medical device manufacturers to have a local representative, who is responsible for handling regulatory affairs and ensuring that products meet safety and quality standards.
By partnering with an Authorised Representative Service in Belarus, manufacturers can benefit from their expertise in navigating the country's regulatory framework and market access requirements.
This can help streamline the approval process for medical devices and facilitate smoother market entry, ultimately allowing manufacturers to focus on their core business while meeting compliance obligations.
In addition, having a local representative can enhance communication with local authorities and customers, leading to improved customer satisfaction and business performance in the Belarusian market. Overall, the use of an Authorised Representative Service in Belarus can be a valuable asset for medical device manufacturers seeking to establish a presence in the country and ensure compliance with local regulations.
The authorised representative BELROSMED serves as a liaison between the manufacturer and the regulatory authorities, handling documentation, post-market surveillance, and communication in the local language. This partnership is instrumental in achieving compliance and successful distribution of medical devices in Belarus.
Translation & Localisation
BELROSMED professionally develops, translates, localizes technical documentation, registration dossiers for manufacturers of medical, veterinary products and equipment.