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| The priority approval process for medical devices in Shanghai opens up the green channel for medical technology innovation |
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| Author：中國(guó)銘鉉 企劃部 Release Time：2017-9-1 11:09:41 Number Browse：798 |
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Medical network - on September 1, Shanghai today from the examination and approval procedures for the second category of medical device is preferred, the urgent clinical needs and listed in the state, the municipal science and technology major projects or focus on research and development program of medical apparatus and instruments will be ordered separately in the process of examination and approval, priority review, ensure that in the case of security to the fastest speed, melancholy for the patient.This is also a "green channel" for medical technology innovation in this city.
Medical instrument refers to the apparatus, equipment and materials used directly or indirectly for human body.Our country implements three-level classified management for medical equipment according to the degree of risk, the priority of the examination and approval procedures for the second category is a moderate risk, and to strictly control the management to ensure the safe and effective medical apparatus and instruments, such as X-ray film machine, B chao deng is a second instrument.
According to Shanghai on the implementation of the examination and approval procedures for the second category of medical equipment priority, priority services including six types: listed in the state or the municipal science and technology major projects, key research and development program of medical apparatus and instruments;Diagnosis or treatment of rare diseases with obvious clinical advantages;Diagnosis or treatment of elderly persons with specific and multiple diseases, and there are no effective diagnostic or therapeutic instruments;Medical devices specially designed for children and with obvious clinical advantages;Medical devices that are urgently needed and other medical devices that should be included in the priority approval process.In addition, the state administration of food and drug administration has identified the second type of innovative medical devices as belonging to the city, and will be given priority approval in accordance with this procedure.
According to introducing, the so-called "priority for examination and approval procedure" is refers to, according to the request of the applicant, the medical equipment product approval process for priority, in the process of registration and review before the examination and approval, set up special channel, the priority for service programs.For example, the municipal food and drug administration will accept the application of the priority approval procedure and the registration application data.
The director of the municipal food and drug administration told reporters that the innovation momentum of medical devices in Shanghai has been gaining momentum over the years.By national food drug administration in 2014 to implement the innovation medical instrument special approval procedures (try out) "after the situation, for example, by the end of last year, the national total of 91 projects into the" green channel ", of which Shanghai 13, 14.3%.In the first four months of this year, seven new entries were added to Shanghai, 30 more were added to the country and 23.3 percent in Shanghai.For this reason, Shanghai not only ranks the first echelon of the most programs in the country, but the growth rate of the project is also one of the best in the country.
"Medical devices ultimately need to be used by people," he said. "it's a matter of life, and any 'green channel' is not about lowering standards, it's about strengthening communication and optimizing processes."City food drug administration commissioner of medical apparatus and instruments, ling feng told reporters, from the national food administration of drug safety to the Shanghai municipal food and drug administration, of medical apparatus and instruments work principle of the "green channel" stressed "standard not lower", on the basis of improve the efficiency of propulsion and on power, as well as the combination of the pipes.
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