🇧🇾 Belarus medical device regulatory data

Advertising of medical products is prohibited without the advertiser holding Minhealth approval (согласование), which is an administrative procedure (8.14.2: 15 days, 1 month where expertise is needed, paid service). Advertising of devices not registered in Belarus is prohibited; advertising of devices not intended for patient self-use is allowed only in specialized editions and professional events; ads must state the product is a medical product, the producer, and a recommendation to read the IFU/consult a doctor.

The national registration certificate is indefinite ('Регистрационное удостоверение является бессрочным'). Reregistration applies only where a certificate issued before 25 July 2022 expires; devices imported or produced while such a certificate was valid may still be sold/used until their shelf-life or service-life expiry.

Ministry of Health of the Republic of Belarus (Министерство здравоохранения) is the authority that carries out state registration of medical products and issues the registration certificate (регистрационное удостоверение) as its permission.

RUP 'Center for Expertise and Testing in Healthcare' (РУП «Центр экспертиз и испытаний в здравоохранении», rceth.by) organizes the preliminary technical works (expertise, inspection, testing), issues conformity conclusions, and is the operator of the State Register of medical devices.

State institution 'State Pharmaceutical Surveillance' (ГУ «Госфармнадзор») carries out state surveillance over the circulation of medical products in Belarus.

Changes to the registration dossier are made for defined events (new name without changing properties; new medical indication; applicant/producer reorganization, name or address change; production site change; changes to technical regulations for domestic devices; adding/removing accessories; labeling/packaging changes; shelf-life/storage changes; risk-class change; IFU changes; size-range additions). Applicants must apply within 3 months of the event, after passing the preliminary technical works and obtaining a positive RUP CEIZ conclusion.

The applicant must inform the Ministry of Health within one month of learning of: a change of production-site address; the device losing medical-product status due to changes in legal/technical acts; or a voluntary recall of the device from circulation by the producer.

A new state registration (not a variation) is required where an already registered device is produced by another producer or where a new production site is added for a registered device.

Clinical trials of medical products are conducted only in state healthcare organizations, after laboratory and other tests confirming safety; participation is voluntary with written informed consent; trials on pregnant women and minors are allowed only where the device is intended exclusively for them; trials are prohibited on orphans, military personnel, detainees/convicts, legally incapacitated persons and persons under forensic examination.

Minimum/maximum clinical trial durations: class 1 — at least 10 and at most 30 calendar days; class 2a — 35 to 70 calendar days; classes 2b and 3 — a period sufficient to establish the corrective effect (implantable devices: at least 70 calendar days). Classification follows the EAEU rules approved by EEC Board Decision № 173 of 22.12.2015.

The Ministry of Health's commission on medical products (комиссия по медицинским изделиям) decides, among registration questions, the expediency of qualifying products as medical products.

'Medical products (медицинские изделия, изделия медицинского назначения, медицинская техника)' = any instruments, apparatus, appliances, equipment, materials and other products used for medical purposes alone or in combination, including accessories and special software, intended by the producer for provision of medical care.

Not subject to state registration: used/refurbished devices; devices produced in or imported into Belarus solely for sale abroad; components of registered devices; raw materials and components for device production; spare parts for repair; devices covered by a Ministry of Health permit for sale/use of unregistered devices; and devices imported by an individual for personal use.

A product is a medical product only if its functional purpose is not achieved by pharmacological, immunological, genetic or metabolic action on the human body (such action may, however, be supported by medicines).

For foreign-produced devices the dossier (Resolution 55, Appendix 1, section 2) includes: application; producer's information letter; registration/market-authorization document from the country of manufacture (legalized/apostilled, notarized translation); QMS conformity certificate for the producer and, where needed, the production site; IFU/operation manual; full-color labeling and packaging sample; shelf-life report; and the producer's power of attorney (original or notarized copy).

Foreign documents for the dossier require legalization or apostille (unless an international treaty of Belarus provides otherwise) and a translation into Belarusian or Russian with notarized certification of the translation/translator's signature; the IFU translation may instead be certified by the producer with the note 'Перевод соответствует оригиналу'.

After a positive RUP CEIZ conclusion from the preliminary technical works, the applicant submits to the Ministry of Health: (1) an application and (2) the RUP CEIZ conformity conclusion; for limited-quantity supplies also the supply contract, its specification and the contract with the healthcare organization or procurement organizer.

The applicant for national registration (reregistration, dossier changes) is: the producer; a legal entity or individual entrepreneur within the same association (объединение) as the producer; or (for devices used in medicine production) a Belarusian pharmaceutical manufacturer that ordered foreign-made devices not registered by their foreign producer. For limited-quantity supplies, any Belarusian legal entity or entrepreneur involved in their circulation may apply.

'Authorized representative of the producer of medical products' = a legal entity, individual entrepreneur registered in Belarus, or a representative office of a foreign organization, empowered by the producer's power of attorney to represent it on circulation matters (incident reporting, recalls, receiving returned devices).

The producer (or its authorized representative) is responsible for the release of a medical product onto the market ('выпуск в обращение' = first transfer making the device available, excluding transfer for testing).

Import into Belarus, production, sale and medical use are prohibited for: substandard, counterfeit and falsified devices; expired devices; unregistered devices (unless legislation or EAEU law provides otherwise); devices with suspended registration or suspended sale/use decisions; devices subject to a withdrawal decision or an official notification of non-conformity requiring withdrawal.

'Circulation subjects' of medical products are legal entities and individual entrepreneurs registered in Belarus and representative offices of foreign organizations that conduct testing, expertise, registration, production, storage, transport, sale, installation, commissioning, medical use, maintenance, repair or destruction of medical products.

The state duty for state registration (reregistration) becomes payable only after the Ministry's decision: the Ministry notifies the applicant within 5 working days of the decision and the duty obligation; the certificate is issued within 5 working days after the applicant confirms payment into the republican budget (payment via the ERIP system).

The IFU (инструкция по применению) or operation manual (руководство по эксплуатации) and other foreign-language dossier documents must be accompanied by a translation into Belarusian or Russian; the labeling/packaging sample must be provided in original color certified by the producer.

Core acts in force on 2026-08-25: Healthcare Law № 2435-XII of 18.06.1993 (as amended 08.07.2024), Art. 391; CM Resolution № 211 of 28.04.2026 (national registration, repeals CM Res. 1269/2008); CM Resolution № 177 of 14.03.2024 (vigilance and recalls); CM Resolution № 548 of 24.09.2021 (unified list of administrative procedures, as amended 27.07.2026); Minhealth Resolution № 42 of 12.05.2022 (administrative-procedure regulations and forms), № 55 of 23.04.2015 (preliminary technical works), № 133 of 02.10.2025 (clinical trials), Order № 1324 of 16.12.2014 (classification); EAEU Agreement of 23.12.2014 and EAEU acts for the EAEU route.

Post-market monitoring on the national route operates through the CM 177 incident system: RUP CEIZ collects and analyzes adverse-event (incident) information from circulation subjects, users and monthly monitoring of foreign regulators' websites; the Ministry of Health supervises. Applicants must also notify the Ministry within one month of site-address changes, loss of device status and voluntary recalls (CM 211 p. 22).

The registration certificate (регистрационное удостоверение) is issued on a security blank in the form annexed to CM Resolution 211; it states the applicant, the device per nomenclature classification, type/model/size (or custom-order group), the producer and production site, the permitted medical use area and restrictions, the registration number and dates.

The current application for state registration (admin procedure 9.3.1) is the form approved under Minhealth Resolution № 42 of 12.05.2022; it requires, among other data: applicant/producer/site identification, nomenclature classification codes (ААА ББ ВВ ГГ), CE-marking presence, indications and use, shelf life, price in the producer's country, and the ERIP (unified settlement and information space) payment reference.

National registration is preceded by production inspection by RUP CEIZ, required when: the device is made on a first-declared production site (except non-sterile foreign class 1); the site was previously declared only for devices circulating in the USA/EU or for EAEU-registered devices (except non-sterile foreign class 1); class 1 (sterile), 2a, 2b or 3 devices are made on a site previously declared only for class 1; the site address changes; or a new site is added. The inspection is conducted under a separate contract by a commission of RUP CEIZ experts.

A QMS conformity certificate for the producer (and production site, where applicable) must be included in the registration dossier; the registration dossier must contain production inspection results confirming compliance with requirements set by the Ministry of Health.

RUP CEIZ maintains a database of substandard and falsified devices identified in Belarus and exchanges information on them with the competent authorities of EAEU member states and other states under international treaties and EAEU law.

Substandard, falsified and expired devices must be withdrawn from circulation, returned to the producer (or its authorized representative) or destroyed, by decision of their owner or of the Ministry of Health. The owner must withdraw them immediately and return them within 30 calendar days; the producer must accept them and perform corrective actions or destroy them within 30 calendar days. A Ministry withdrawal decision is issued by ministerial order within 15 working days of a written notification, published on the official sites within 3 working days.

Belarus operates two parallel market-admission routes: national state registration by the Ministry of Health (CM Resolution 211/2026, admin procedure 9.3.1) and registration within the EAEU framework under the Agreement of 23.12.2014 (admin procedure 9.3.6). Devices may be placed on the market after either registration.

National registration, reregistration and dossier changes are preceded by a package of preliminary technical works run by RUP CEIZ: primary document expertise, production inspection, biological-effect testing (all devices), technical testing (domestic devices only), specialized document expertise, Ministry-assigned clinical trials, and clinical evaluation based on clinical data with proof of equivalence (for large fixed equipment and class 1 devices).

State registration is required for: devices first created in Belarus; foreign-made devices first offered in Belarus; devices analogous to registered ones but made by another producer; previously registered devices when a new production site is added; components of other devices that are sold/used separately; and limited-quantity supplies for defined public-interest purposes.

The total duration of the preliminary technical works (expertise, inspection, testing) may not exceed 90 calendar days, extendable by agreement between RUP CEIZ and the applicant to at most 150 calendar days.

Devices supplied in limited quantity may be registered via a dedicated route (procedure 9.3.5) where they are: supplied to state healthcare organizations for international health programs; needed for use in emergencies or for diagnosis of new, natural-focal or especially dangerous infections; or delivered as foreign gratuitous aid. The certificate carries the 'ОК' mark; the file adds supply contracts to the standard documents.

The Ministry of Health may issue a permit for the sale and/or medical use of unregistered medical products; devices imported by an individual for personal use are exempt from registration. Residents of the China-Belarus industrial park 'Great Stone' may obtain admission of unregistered devices for medical use (procedure 9.141.2, 15 days, free of charge).

The Ministry of Health's commission on medical products handles applicants' disagreements with RUP CEIZ conformity conclusions and product-qualification questions. Refusal of registration (reregistration) is only possible on grounds of the Law 'On the Basics of Administrative Procedures' № 433-З or where the same device is already registered by another applicant under the same trade name or required documents were not provided; decisions are taken by ministerial order and communicated within 5 working days.

The State Register of Medical Products (Государственный реестр изделий медицинского назначения и медицинской техники) is a public state information resource owned by the Ministry of Health and operated by RUP CEIZ; it records device name/type, nomenclature name, applicant, producer, production sites, registration number and date, validity, status, annulment date, use area and IFU availability, and is published on the official sites of the Ministry and RUP CEIZ.

Circulation subjects must notify RUP CEIZ of an adverse event (incident) using the prescribed form (извещение) within 20 calendar days of the event; where there is a serious threat to user health, immediately but no later than 2 working days. After a confirmed incident the producer (or its authorized representative) must submit an incident report (отчет) within 30 calendar days of receiving/sending the notification, or within 2 working days for serious threats.

Failure of the producer (or its authorized representative) to report an adverse event (incident) to RUP CEIZ, or breach of the prescribed procedure/deadlines, is a ground for the Ministry of Health to suspend the registration certificate (or individual registration numbers); RUP CEIZ informs the Ministry of such facts within 3 working days.