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 the functioning of the Ukrainian language as the state language” and the Order of the Ministry of Economic Development dated 04.08.2015 No. 914
Basic principles for conducting market surveillance and control of medical devices. Main types of nonconformities

Nikolay Matlaev, The lead auditor on certification of quality management systems and conformity assessment with technical regulations of the “Ukrainian Scientific Institute of Certification”

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