Features of the classification. Medical devices on the border of definitions.

25.06.2020

PharmaTechExpo Journal №1-2, 2020.

The text of the article is available only in Ukrainian

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11.10.2021

How to make interlaboratory comparisons of test methods

PharmaTechExpo Journal | SPECIAL ISSUE 2021 The text of the article is available only in Ukrainian

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12.08.2022

Changes in the medical device regulation in Ukraine

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 […]

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23.01.2020

Guidelines for medical devices

The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]

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