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Quality management // № 5 (41), May 2021
The text of the article is available only in Ukrainian
In connection with the establishment of conformity assessment processes and the possibility of carrying out works that ensure the availability of the necessary products on the Ukrainian market with confirmed safety and efficiency, on August 9, 2022, the Ministry of Health withdrew the letter dated February 25, 2022 No. 24-04/5396/2-22 allowing the placing of the […]
Read moreJournal “Standardization, certification, quality” № 4 (122)/2020 Over the past decades, the frequency of using software in various areas of human life has increased significantly. In particular, this product has taken an important place in the medical industry. For example, as an integral part of a medical device (software incorporated in medical devices or pacemaker […]
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 […]
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