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Belrosmed Contacts
Belrosmed is online 7 days a week, 24 hours a day. This allows us to reduce the cost of our services. Order registration and certification of medical devices online. Save your time and money! Feel free to write and call us with any questions. We love to communicate with our clients. "Belrosmed is always nearby and always in touch.
BELROSMED® - Expert agency for registration, certification, consulting, marketing, distribution in Belarus of medical devices, equipment, medicines, food supplements, fine food, cosmetics.
BELROSMED® - Expert Agency is managed by IP Filippov S.D.
IP Filippov S.D., REG.N. 19355749
220062, Minsk, Belarus, PB 57
Telephone: +375 29 810-72-77
WhatsApp: +375 29 210-72-77
E-mail: germanica@me.comWEB: https://belrosmed.com
Our expert services:
- Registration, re-registration
- Development of documentation
- Development of dossier
- Medical translation
- Marketing and promotion
- Import - Export CIS countries
- Distribution and supply of medical devices and equipment
Feel free to write and call us with any questions. We love communicating with our customers. BELROSMED is available 24/7.
We speak English, German, Russian, Byelorussian languages.
BELROSMED® - Trade Mark of IP Filippov S.D., REG.N. 19355749, 220062, Minsk, Belarus, Prospect Pobediteley 104, Tel.:+375 29 210-72-77
FAQ. How much does it cost to register medical devices in Belarus and to find a distributor?
FAQ. How much does it cost to register medical devices in Belarus and to find a distributor?
- All Medical Devices must be registered with the Belarus MOH. Foreign manufacturers intending to import Medical Devices in Belarus must appoint an Authorized Representative.
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).
999* € - One Month Authorised Representative Contract (finding and establishing long lasting contracts with reliable distributors) in Belarus (price is negotiable)
*Local taxes (10-20%) are not included.
BELROSMED Benefits
- Creating medical device's dossier including product and package label in Russian/Belarusian language, IFU, TI.
- Translation and notarisation of medical device's dossier in Belarus with 25% discount.
- Completing medical device's registration within 4-5 months for medical devices with EU MDR.
- Completing medical device's registration within 6-7 months for medical devices without EU MDR or with country export certificate.
- Searching, finding, establishing contacts and signing a long-term contract with a reliable and financially secure importer or/and distributor in Belarus.
- Establishing trusting relationships and contacts with the end users: doctors, medical specialists, clinics, hospitals, medical specialists, medical universities and colleges.
- Conducting seminars, webinars, participating medical exhibitions and fairs, creating posts and advertising campaigns in internet.
- Creating or strengthening a positive brand image of a manufacturer or medical device among medical influencers, specialists and end users.
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)
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
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.
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.