{"id":3471,"date":"2017-07-25T10:23:11","date_gmt":"2017-07-25T08:23:11","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=3471\/"},"modified":"2025-06-24T11:54:21","modified_gmt":"2025-06-24T09:54:21","slug":"medical-device-registration-belarus","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-belarus\/","title":{"rendered":"Medical Device Registration in Belarus"},"content":{"rendered":"
\"biellorussia\"<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

Ministry of Health of the Republic of Belarus (MoH)<\/p>\n

Classification<\/strong><\/h5>\n

Class I, IIa, IIb, III (risk-based classification)<\/p>\n

Quality System Standards<\/b><\/h5>\n

GOST ISO 13485: -2017<\/p>\n

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<\/i><\/span>The information on this page is valid and current as of June 2025. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

Belarus<\/strong>, a member of the Eurasian Economic Union (EAEU) <\/strong>since 2015, along with Russia, Armenia, Kazakhstan, and Kyrgyzstan, has switched to a unified, supranational medical device registration system. After a transitional period during which national registration was also permitted, as of January 1, 2026<\/strong>, registration of medical devices will be possible exclusively through the EAEU system.<\/strong><\/p>\n

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EAEU Registration Procedure<\/span><\/h3>\n

The procedure is standardised and involves several Member States:<\/p>\n

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  1. Choice of Reference State
    <\/strong>The applicant selects an EAEU Member State (e.g. Belarus or Russia) that will guide the entire evaluation and approval process.<\/li>\n
  2. Involvement<\/strong> of other Member States <\/strong>
    It is mandatory to be involved in at least one other EAEU Member State. This ‘involved’ state will examine and approve (or reject) the conclusions and decisions made by the reference state.<\/li>\n
  3. Registration Dossier
    <\/strong>The complete documentation, in electronic format, is submitted via the EAEU platform operated by the Eurasian Economic Commission (EEC).<\/li>\n
  4. Technical evaluation and testing
    <\/strong>The Reference State carries out the technical evaluation of the dossier and manages any laboratory tests needed to verify the safety and performance of the device.<\/li>\n
  5. Manufacturing Site Inspection<\/strong>
    This inspection is mandatory for complex, innovative or Class IIa (sterile), IIb and III devices. It is conducted by the reference state according to Good Manufacturing Practice (GMP) standards.<\/li>\n
  6. EAEU Certificate of Registration
    <\/strong>Once the device is approved by both the reference state and all member states involved, the EAEU Certificate is issued. This certificate is valid in all EAEU countries that actively participated in the procedure.
    For other EAEU countries not initially involved, a mutual recognition procedure can be initiated.<\/li>\n<\/ol>\n

    Applicant <\/span><\/h3>\n

    Manufacturers not established in the EAEU must appoint an Authorised Representative (AR) based in one of the member EAEU countries. This AR will act as the point of contact and will be responsible for the compliance of the device.<\/p>\n

    Registration times<\/span><\/h3>\n

    They generally vary from 12 to 24 months, depending on the risk class of the device and the complexity of the documentation. Production site inspections can add up to 90 days to the process.<\/p>\n

    Validity of the EAEU Certificate<\/span><\/h3>\n

    The EAEU Registration Certificate is valid indefinitely, unless there are significant regulatory changes or substantial changes to the device itself.<\/p>\n

    Documentation Language and Labelling<\/span><\/h3>\n
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    • Documentation: The main documentation must be submitted in Russian and\/or Belarusian. Documentation in English is accepted if accompanied by a certified translation.<\/li>\n
    • Labelling and IFU (Instructions for Use): They must be provided in Russian and\/or Belarusian.<\/li>\n<\/ul>\n

      Useful information<\/span><\/h3>\n

      Possession of an EC certificate does not exempt one from registration under the EAEU system. However, technical documentation already prepared for CE marking can be partially reused by adapting it to the specific EAEU requirements.<\/p>\n

      At least one other Member State must indeed approve the registration in addition to the reference State, but in practice, manufacturers tend to involve several States from the outset to ensure automatic validity in the relevant markets.<\/p>\n

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        Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n