Legal and de facto: Office 320, Kudryavsky descent 7, 04053 Kyiv
See on the map Monday - Thursday 9.00 - 18.00 Friday 9.00-17.00, without break
Feedback
PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]
Read moreThe text of the news is available in Ukrainian
Read morePROGRAM Temporary changes in the rules of import of medical devices and personal protective equipment needed to prevent the COVID-19 Conformity assessment procedures: self-declaration or assessment with the involvement of a designated body Requirements for accompanying documentation: labeling, instructions for use, declaration of conformity Application of the requirements of the Law of Ukraine “On ensuring […]
Read moreOr find the answer here
*All fields are required