Joint meeting of the RSPP (Russian Union of Industialists and Entrepreneurs) and the Committee of Entrepreneurship
July 4, 2013 in the RSPP (Russian Union of Industialists and Entrepreneurs), a joint meeting of the Commission of the RSPP pharmaceutical and medical industry, the Commission RSPP health industry and the Committee of Entrepreneurship in health and medical industry, which considered the issue of "state regulation of medical devices in circulation due to the entry into force Art. 38, 95 and 96 of the Federal Law № 323-FZ "On the basis of health protection in the Russian Federation and the measures taken to address the problems encountered in the registration and renewal of registration certificates."
Participants of the meeting discussed the report of the Co-Chair of the RSPP pharmaceutical and medical industries, the President of the Union of Associations and enterprises of the medical industry Kalinin YT "On improving the regulatory treatment of medical devices with the increase of their efficiency, safety and competitiveness both in the domestic and foreign markets."
The meeting was attended by the Chairman of the Commission of the RSPP health industry Skulls VM, Acting head of the Russian Ministry of Health Roszdravnadzor Murashko MA, Head of the Department of drug provision and regulation of medical devices Monogarova II Russian Ministry of Health, Member of the Board of Trustees Board Ural pharmaceutical cluster, the deputy of the State Duma AP Petrov, Vice-President of the Union of associations and enterprises of the medical industry, the president of the association "ZDRAVMEDTECH" Ruchkin Alexander, Director General of the Kazan Medical Instruments Plant SHAKIROV NH, President of the Company "Medical Technologies Ltd" Dabagov AR, Deputy Director General of Institute of FGBU MT Roszdravnadzor Olga Romanov, the members of the commissions and committees, heads of enterprises and industry associations.
The meeting noted that the currently existing regulatory and technical documents regulating the handling of medical devices requires a major adjustment, given the current level of scientific, technological, and organizational achievements in this field both in Russia and in the leading countries of the world.
During the discussion of specific proposals were made by changing the order of state registration of medical devices, the procedures for conformity assessment in the form of technical tests, toxicological studies, clinical trials of medical devices to their state registration, approval of the nomenclature classification.
Given that these activities require amendments to the federal laws, the Government of Russian Federation and the orders of ministries and departments, the participants made suggestions for the Ministry of Health to create a Russian interagency working group with representatives of Industry and Trade of Russia, Roszdravnadzor professional and community organizations, which entrust this work .
The comments and proposals prepared for the meeting will be sent to the State Duma, the Government of the Russian Federation, the Russian Industry and Trade Ministry and the Ministry of Health of Russia.
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