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Circulation of Medical Devices: Norm and Right

A meeting was held at the Russian Union of Industrialists and Entrepreneurs, organized by the RUIE Commission on the industry of health, RUIE Commission on pharmaceutical and medical industry, and the Committee of Commercial and Industrial chamber of the Russian Federation on entrepreneurship in the field of healthcare and medical industry.

The topic of discussion was highly topical: “Regulatory Circulation of Medical Devices at Modern Conditions”.

Summarizing the decisions of profile Commissions of the RUIE and CIC Committee on normative regulation of medical device circulation, the chairman of Commission of RUIE on pharmaceutical and medical industry Yuri Kalinin told about improvement of the process of registration of medical devices, improvement of material and technical base of expert organizations, improvement of expert qualification. Talking about evidently positive shifts in the medical industry, he remarked with sorrow a low coefficient of launch to market of new drugs, slow formation of regulatory base.

Commenting on the report of Yuri Kalinin deputy director of Department of Development of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia Dmitriy Kolobov reminded that the State Duma of the Russian Federation introduced a legislative act of exemption from value added tax of raw materials and components for manufacture of medical commodities, supporting local manufacturers of medical devices, raw materials and components. He also told about the documents introduced into the Government aimed to improve the law enforcement practice.

Practical  issues of improvement of the system of medical device registration were also discussed.


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