Regulations for import of medical products for the purpose of state registration

The EAC Declaration of the Eurasian Economic Union (EAEU) is an official document that proofs, that the products meet the minimum requirements of the technical regulations of the EAEU. An EAC declaration is issued by the manufacturer, importer or an authorized representative and listed in the official register. Those products, whose conformity with the technical regulations are confirmed by the declaration, have the permission to be freely moved and sold in the whole customs territory of the member states of the EAEU.

The EAC certificate can only be issued after a quality assessment, which has to be carried out by a certification body accredited in one of the member states of the Eurasian Economic Union. The certification is conducted on the basis of technical documentations, company-internal created test reports, or rather test reports provided by accredited test laboratories, as well as on basis of a manufacturing audit on site. The certificate is printed on an official pre-printed form, which has several forgery-proof elements and is authenticated by the signature and seal of an accredited body. The EAC certificate is usually issued for “complex” products that require an extensive control by the authorities.
With the EAC Declaration the manufacturer, importer or authorized representative declares the conformity of his products with the minimum requirements of the technical regulation of the Eurasian Economic Union (EAEU). As distinguished from the EAC certificate, the EAC declaration is issued by the manufacturer or importer himself. All necessary tests and analysis are or made by the manufacturer or in some cases by the laboratory. The applicant issues the EAC declaration himself on a usual piece of paper. The EAC declaration has to be listed in the uniform register of the EAEU by an accredited certification body of one of the member states of the EAEU.