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Center for Clinical Trials of Innovative Medical Devices FSBI National Quality Institute Roszdravnadzor

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2022: Opening of the Center for Clinical Trials of Innovative Medical Devices

On April 18, 2022, the opening of the Center for Clinical Trials of Innovative Medical Devices of the Federal State Budgetary Institution "National Quality Institute" of Roszdravnadzor took place. It was created as part of the implementation of the draft National Action Plan for the Establishment of a System for the Accelerated Introduction of Medical Products.

According to the press service of Roszdravnadzor, this is Russia's first clinical testing center for innovative medical devices for in vitro diagnostics that have no analogues (comparison products) in the Russian Federation. The laboratory is designed for unique trials and studies of the quality, effectiveness and safety of pre-systems and antigen tests for the diagnosis of most infectious diseases and hereditary pathologies.

On April 18, 2022, the opening of the Center for Clinical Trials of Innovative Medical Devices of the Federal State Budgetary Institution "National Quality Institute" of Roszdravnadzor took place.

Conducting clinical trials of products for in vitro diagnostics based on next-generation sequencing and PCR in real time will allow timely diagnosis, treatment and prevention of cardiovascular, oncological and infectious diseases, which in turn will make a significant contribution to the development of high-quality and safe healthcare in the Russian Federation.

Also, one of the tasks of the center is to create a bank of standard samples of biological materials for the development of standardization in the field of invitrodiagnostics, which will get rid of import dependence in this area.

The head of Roszdrav Alla Samoilova emphasized that the new laboratory is "the unique and first laboratory in the country, which combined the entire range of studies to bring innovative drugs to the market for diagnosis, that is, mainly for test systems."

By April 18, 2022, the Center for Clinical Trials of Innovative Medical Devices of the Federal State Budgetary Institution "National Quality Institute" of Roszdravnadzor received the necessary license and accreditation, and also fully prepared a laboratory to fulfill its tasks.[1]

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