Remote audits of global manufacturers of medical devices

Journal “Laboratory” No. 08/2020 The text of the article is available only in Ukrainian

Documents required for legal placement of medical devices on the market. Market surveillance.

PROGRAM 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 […]

Conformity assessment of personal protective equipment in accordance with the new Technical Regulations No. 771