Medical News & Views from Belarus

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.

500* € - One Time - Authorised Representative Contract (medical consulting services)
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.

999 € - One Product Registration
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).

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.

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.

• 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)

*From the date of receipt of the entire set of documents from the manufacturer. We will definitely speed up the registration process if you entrust us with the collection of documents for the dossier, preparation, translation, national legalisation and notarisation of the dossier in Belarus.

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.

To calculate the cost of registration it is necessary to determine:

1. 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.
2. Determine the cost of work of the consulting company
3. Determine the cost of work of the authorised body (CEIZ of the Ministry of Health of the Republic of Belarus)
4. Determine the cost of testing in laboratories and clinical bases
5. 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.