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Center for Testing and Examination of Medical Devices

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2022: Establishment of a center for testing and examination of medical devices

In early October 2022, the head of the Moscow Department of Health (DZM) Alexei Khripun signed a decree on the creation of a center for testing and examination of medical devices. It will be organized in the structure of the departmental Diagnostic Center for Laboratory Research (DCLI). The amount of expenses under the project was not disclosed.

According to the document, the center plans to assess the biological effect of medical devices, technical, microbiological, clinical, clinical and laboratory tests, toxicological studies of medical and other devices used in medical activities.

Moscow Department of Health creates a center for testing and examination of medical devices

The production sites of the IC are the Moscow Scientific and Practical Center for Narcology, the Sklifosovsky Research Institute of Emergency Medicine, and the Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies.

It is noted that the main task of the Center for Testing and Expertise of Medical Devices is to prevent the supply of products to the medical organizations of the DZM that do not meet the characteristics declared by the manufacturer. In the practice of the center, it is planned to introduce test methods that comply with the requirements of national and international standards, technical documentation of manufacturers.

The center will be funded by funds from the income-generating activities of the DCLI, including by conducting tests for external applicants on a commercial basis.

This is not the first exit of DZM institutions to the site of testing medical devices. In May 2022, the Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies received the right to conduct clinical trials of medical devices according to the rules of the EAEU, including IT solutions based on artificial intelligence technologies.

MOSCOW CITY HEALTH DEPARTMENT ORDER

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Шаблон:Remarks