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Верховна Рада України
Президент України
Уряд України
МОЗ України
ДЕРЖАВНА СЛУЖБА УКРАЇНИ З ЛІКАРСЬКИХ ЗАСОБІВ
Національне агентство з акредитації України

Conformity assessment


Medical products (other than those made to order or intended for clinical investigations), which are considered to meet the requirements of the relevant Technical Regulations, shall be marked with a mark of conformity with the technical regulations before they are put into circulation in the customs territory of Ukraine.

Requirements for marking conformity with technical regulations are specified in the Resolution of the Cabinet of Ministers of Ukraine of December 30, 2015 № 1184 "On approval of the form, description of the mark of conformity with technical regulations, rules and conditions for its application". Marking with a mark of conformity with the technical regulations shall be made, at the manufacturer's decision, on the medical product or on its packaging, as well as on the instructions for use of the medical product, if such an instruction is compulsory. The indicated marking should be clearly visible, legible and should not be erased. Marking with a mark of conformity with the technical regulations may be affixed to the label of the medical product.

Along with the conformity mark with the technical regulations, the identification number of the compliance assessment body responsible for conducting the conformity procedures (if any) is indicated. According to the explanation of the Ministry of Economic Development from September 27, 2016 No. 3431-09
format of the identification number of the conformity assessment body UA.TR.YYY, where: UA - the conventional symbol of Ukraine in Latin letters; TR - conditional designation of the conformity assessment body, which is intended to perform works on conformity assessment to the requirements of technical regulations; YYY is the ordinal number of the conformity assessment body. Taking into account the above, the identification number of the conformity assessment body of the State Enterprise "SMCC" by the Ministry of Health of Ukraine UA.TR.067 and is as follows:

It is prohibited to affix signs or inscriptions which may mislead the third person as to the meaning or graphic representation of the marking by the conformity marking with the technical regulations. Any other mark may be affixed to a medical product, package, or instruction supplied with a medicinal product, provided that this does not reduce the visibility and legibility of the marking with a mark of conformity with the technical regulations.