Labeling of medical devices intended for showing, demonstrations at the place of fairs, exhibitions.

23.09.2020

Other news

15.04.2021

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 […]

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26.10.2023

Good manufacturing practice: overview of the principles and requirements of the DSTU EN ISO 22716 (GMP) standard

Text is available only in Ukrainian

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04.09.2023

The 12th Ukrainian Forum of Medical Devices Market Operators was held

On August 31, the 12th Ukrainian Forum of Medical Devices Market Operators was held, which provided manufacturers, suppliers, distributors, and importers of medical devices with a platform for solving all urgent issues, discussions, recommendations, and sharing valuable experience in doing business during martial law. The Ukrainian Scientific Institute of Certification traditionally sponsored this event. In […]

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