By clicking the SUBMIT button, I confirm that I agree to the processing and storage of personal data and the policy of this website. This site uses cookies to make it more convenient for you to use. Learn more.
Registration + Distribution of medical and veterinary devices in Belarus
BELROSMED provides expert support for the medical and veterinary devices state registration plus distribution among 1500+ end customers in Belarus:
- Strategic Regulatory Consulting
- Strategic business development focusing on the Belarus market
- Regulatory roadmap for market access
- Dossier preparation, review and management
- Regulatory Submissions
- Market assessments
- Public relations and marketing
- In-country Authorised Representative Service
- Direct sales at Belarus State Medical Auctions / Tenders
15 years of experience
15+ years of sales and distribution management experience in Belarus
10 years of experience
10+ years of registration and certification experience in Belarus
700+ PRODUCTS
700+ products and services have been certified in Belarus since 2005
35+ COMPANIES
30+ international companies have chosen BELROSMED as their partner
Your Ambassador in Belarus
Maintaining, supporting and advising your project at all stages. Belrosmed provides professional services on establishment of new registration, renewals and variations, safety and quality management for medical devices in Belarus.
Authorized Representative Belrosmed connects you with national consumers, conformity assessment bodies and state authorities, importers and distributors, performs post-marketing supervision.
Translation & Localization
Belrosmed professionally develops, translate and localize the Technical Documentation and Registration Dossier for international manufacturers of medical devices and equipment.
BELROSMED SERVICES
BELROSMED 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 specializes in import-export trade, distribution, sales in Belarus, Russia of health products, healthy foods, supplies of medical equipment, devices, disposables to the end consumers.
State registration & distribution of medical and veterinary devices
Firstly, it is important to highlight the significance of regulatory compliance in the registration of medical and veterinary devices in Belarus. The regulatory framework in Belarus mandates that all medical and veterinary devices undergo thorough assessment and registration processes before they can be marketed and distributed in the country. This involves submission of detailed technical documentation, clinical data, and evidence of the device's safety and performance. Furthermore, registration requires a comprehensive understanding of the country's specific regulatory requirements, which often include compliance with international standards such as ISO and CE certifications.
In addition to regulatory requirements, the distribution of medical and veterinary devices in Belarus demands a strategic and well-structured approach. This involves navigating the country's healthcare and veterinary market landscape, understanding the needs and preferences of the end-users, and establishing efficient supply chain networks. Effective distribution channels, such as partnerships with local distributors and healthcare providers, are critical in ensuring the accessibility of medical and veterinary devices to the intended end-users.
Another important aspect to consider in the registration and distribution of medical and veterinary devices in Belarus is the need for ongoing support and maintenance services. Providing training, technical support, and after-sales services contribute to the overall success of these devices in the market. For medical devices, ensuring that healthcare professionals are well-trained in the use of the devices is vital for optimal patient care. Similarly, for veterinary devices, supporting veterinarians with technical expertise and training is essential for the wellbeing of animals.
Furthermore, it is vital to recognize the role of innovation and technological advancement in the registration and distribution of medical and veterinary devices in Belarus. The continuous emergence of new technologies, such as telemedicine, point-of-care testing, and advanced imaging systems, presents opportunities for the improvement of healthcare and veterinary services in the country. This requires proactive engagement with global manufacturers and developers of medical and veterinary devices, as well as the introduction of innovative products that align with the evolving needs of the Belarusian market.
In conclusion, the registration and distribution of medical and veterinary devices in Belarus is a multifaceted process that necessitates adherence to regulatory standards, strategic market insights, ongoing support services, and an openness to innovative technologies. As the healthcare and veterinary industries in Belarus continue to advance, the successful registration and distribution of medical and veterinary devices are integral in driving positive impacts on patient care, animal health, and overall healthcare outcomes in the country.
Belarus Market Overview
Belarus has emerged as a promising hub for medicines and medical device manufacturers, presenting a host of business opportunities. The country's progressive regulatory environment and growing healthcare sector make it an attractive destination for investment. With an increasing demand for advanced healthcare solutions, Belarus offers a fertile ground for companies looking to expand their market reach. Its strategic location in Eastern Europe further enhances its appeal, serving as a gateway to the regional market. For companies seeking to thrive in the healthcare industry, Belarus holds immense potential for growth and success.
Marketing and pre-market research
Marketing and pre-market research are crucial for successful distribution of medical devices in Belarus. Understanding the local healthcare landscape, competition, and consumer needs is vital. Conducting thorough market research allows for targeted marketing strategies, effective product positioning, and informed decision-making regarding market entry. Moreover, it helps manufacturers comprehend regulatory requirements, market demand, and potential barriers. Achieving success in Belarus' medical device market hinges on a well-designed marketing approach supported by comprehensive pre-market research, enabling companies to meet the demands of both patients and healthcare professionals while navigating the regulatory environment effectively.
Belrosmed benefits and experience
Our approach is based on 20 years experience working for manufacturing companies nationally - internationally in medical industries. BelRosMed specialist have experience working both with auditors and as auditors.
Quick start
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.
BelRosMed offers expert 24/7 support for medical devices registration under the Republic of Belarus procedures.
We save your budget
BelRosMed saves your company's budget by getting quality service from one provider, reducing your staff. Keeping your own specialists or doing it yourself is difficult and costly.
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 results
BelRosMed guarantees a successful registration dossier initial expert appraisal within 30 to 60 days after we receive the necessary documents from the manufacturer.
FAQ. How much does it cost?
1.1 $ 4.800 - BELROSMED SERVICE one time contract. Possible discounts are negotiable.
1.1.2. $ 40.000 - BELROSMED SERVICE one year contract - up to 10 medical device registration. Possible discounts are negotiable.
1.1.3. $ 36.000 - BELROSMED SERVICE one time contract - up to 10 medical device registration + Authorised Representative***.
1.2 $ 512,40 - State fee for primary examination of documents.
1.3 $ 2.136,17 - State duty for carrying out a set of preliminary technical works prior to state registration.
1.4* Inspection (when registering a new production site not previously inspected by the Ministry of Healthcare of the Republic of Belarus).
- $ 6.800 ** - Departure of two expert auditors (2 days inspection + 2 days on the road) - 6800 $**.
- $ 10.200* - Departure of three expert auditors (2 days inspection + 2 days on the road) - 10200 $**.
1.6 $ 145 - State duty for registration - 145 $
TOTAL: $ 15.093,57 - (visit of 2 expert auditors+sanitary and hygienic expertise)
TOTAL: $ 15.993,57 - (visit of 3 expert auditors+sanitary and hygienic expertise)
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 US (FDA) or CE certificate for compliance with Directive (EU) 2017/746 or (EU) 2017/745).
** 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.
***
- Complete unlimited medical device registration projects (dossiers) within a year.
- Conduct marketing research.
- Find importer and distributor.
- Connect you with consumers, distributors, government agencies, provide post-marketing oversight.
- Establish trusting relationships and contacts with the end users: doctors, medical specialists, clinics, hospitals, wholesalers, internet trade.
- Conduct seminars, webinars, medical exhibitions, publish analytical articles, and posts in interactive magazine.
- Create, manage and promote medical devices via manufacturer's Belarus website.
- 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)
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.
- 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
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.
Do you want to distribute your Medical / Veterinary Devices in Belarus? Contact us!
By clicking the SUBMIT button, I confirm that I agree to the processing and storage of personal data and the policy of this website. This site uses cookies to make it more convenient for you to use. Learn more.
By clicking the SUBMIT button, I confirm that I agree to the processing and storage of personal data and the policy of this website. This site uses cookies to make it more convenient for you to use. Learn more.