State registration of medical devices in Belarus and Kazakhstan
We manage the full turnkey registration cycle, from documentation review through issuance of the Registration Certificate.
We cooperate with the national center for expertise of medicines and medical devices of the Republic of Kazakhstan and the center for examinations and tests in health service of the Republic of Belarus
Full support throughout all stages of the procedure, including communication with the registration authority
Assistance with technical, toxicological and clinical testing in accredited laboratories and medical organizations
Preparation of the complete document set, from the application and operating documentation to the risk management file
Registration conditions and timelines in EAEU countries
Ministry of health of the Republic of Belarus
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Expert organization:Center for Examinations and Tests in Health Service (confirmed by the applicable Memorandum of Cooperation) - 2026 status:The transitional period for medical-device registration has been extended until 31 December 2027 (Decree No. 441 dated 17 December 2025)
- Available procedures:Registration is possible under either national legislation or EAEU rules
- Registration timeline:
- Under national rules — determined individually;
- Under EAEU rules — approximately 12 to 24 months depending on the risk class
- Additional requirements:Appointment of an authorized representative in the EAEU; translation of documentation into Russian/Belarusian as required
- Registration certificate validity:Registration under EAEU rules is valid indefinitely
Registration in the Republic of Kazakhstan
- Regulator:Committee for medical and pharmaceutical control of the ministry of health of the Republic of Kazakhstan
- Expert organization:National center for expertise of medicines and medical devices
- 2026 status:The transitional period for medical-device registration under national rules has been extended until 31 December 2027 (Protocol dated 29 December 2025).
- Available procedures:Registration is possible under either national rules or EAEU rules
- Registration timelines:
- Under national rules — reduced to 100 working days through the integrated one-stop-shop service;
- Under EAEU rules — approximately 6 to 12 months;
- For devices from jurisdictions with a strong regulatory reputation (United States, European Union, United Kingdom, Japan) — up to 15 working days under the accelerated procedure.
- Additional optionsBeginning in 2026, a pilot one-stop-shop project enables electronic submission through a unified digital interface
- Registration Certificate validity:Under EAEU rules — indefinite
Under national rules — determined by the validity period of the certificate, with the possibility of applying before expiry
Work Stages
Initial audit
- Expert review of the technical documentation provided.
- Identification of regulatory requirements for the specific task.
Document preparation
- Development, revision and translation of operational documentation.
- Preparation of a turnkey document package.
Procedure management
- Coordination of the required tests and laboratory studies.
- Full expert support during the state expert review.
Completion and Handover
- Monitoring of data entry into state registers.
- Handover of the finalized forms and documents to the client.
Registration dossier — main documents
We provide professional support in developing, revising and preparing all required registration-dossier documents, including:
- State registration application
- Information on the regulatory documentation applicable to the device
- Manufacturer technical documentation
- Extract from the technical file / Technical Specifications
- Risk management file
- Manufacturer reports and qualification test reports
- Manufacturer operating documentation
- Technical test reports
- Toxicological study results
- Type-approval test results for measuring instruments, where required
- Documents confirming clinical effectiveness and safety
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Companies
Services for obtaining medical device Registration Certificates and preparing medical device documentation. We work in accordance with EAEU rules and Roszdravnadzor requirements.
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