Circulation of medical devices and medical equipment has its peculiarities in each country around the globe, and Belarus is no exception.
This review aims at more than depicting a specific regulation pattern applied to medical goods in Belarus, its goal is to help you to independently assess risks and form a competent and impartial judgement about the business opportunities in Belarus. This review offers a comprehensive presentation of norms that regulate the circulation of medical goods in Belarus.
We believe that this review will be most useful for companies that treat Belarus as their prospective market, either for the production or for the sales of medical goods. This review contains characteristics of regulations applied to all business spheres, from registration and imports to price formation for medical devices and equipment, as of February 1, 2020.
We believe that this review will answer your questions and will be a good guide for your business decisions.
1. STATE REGISTRATION OF MEDICAL PRODUCTS
1.1. GENERAL PROVISIONS
In order to be sold and used in medicine in Belarus, medical goods must undergo the procedure of state registration.
State registration verifies the conformity of medical goods to applicable requirements for:
These requirements are established by the legislation of the Republic of Belarus or by EAEU legislation, as shown in the below table.
The national rules for medical goods registration in Belarus have been established by Resolution No. 1269 of the Council of Ministers dated 02.09.2008.
State registration is mandatory for the following medical goods:
- newly created and offered for medical use in Belarus;
- manufactured in another country and for the first time offered for medical use in Belarus;
- registered earlier and offered for medical use for another medical indication;
- similar to registered medical goods but produced by another manufacturer.
Moreover, medical goods are subject to state registration where a manufacturer or a production site of such goods has been altered and/or added.
State registration is not carried out in respect of:
- previously used and repaired medical goods;
- medical goods manufactured in Belarus under orders and according to documentation of foreign companies, where such medical goods are intended for sale outside Belarus;
- component parts of registered medical goods;
- raw stuff, materials and component parts for the production of medical goods in the Republic of Belarus (according to manufacturer's technical standard documentation);
- spare parts for repairs and maintenance of registered medical goods;
Period Procedure before December 31, 2021
Applicants may choose registration under national rules or under EAEU rules.
However, national registration will only be valid within the territory of Belarus and only till December 31, 2021.
after December 31, 2021 Only medical goods registered according to single EAEU rules will be allowed in the EAEU territory1
- medical goods subject to a duly MPH permit for realisation and/or medical use of non-registered medical goods;
- medical goods imported in Belarus by a natural person for personal use.
Also, registration is not required for sales and application of medical goods under MPH permits. Those are granted in the following cases2:
- medical goods designed for research activities and international health care programmes;
- medical goods supplied for emergency needs of state agencies, in particular those intended to mitigate effects of natural calamities, catastrophes, epidemic diseases, and medical goods supplied in limited quantities in other exceptional cases;
- medical goods used for treating limited cohorts of patients or patients with rare pathologies;
- medical goods supplied as foreign gratuitous aid;
- samples of medical goods intended for research activities as part of state registration (re-registration) procedure;
- non-registered medical goods/equipment imported in the territory of Belarus during the validity period of an expired registration certificate.
1. Information of EAEU registration rules is provided in Section 7 hereof.
2. A list of documents required for MPH permit is described in cl. 10.28 of the List of administrative procedures.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.