Tang Zhaokun: Medical devices is superintended affect safety of common people life

Second year medical school

Medical devices is superintended affect safety of common people life
-- visit Guangdong to save food medicines and chemical reagents to supervise management board medical devices to manage Tang Zhaokun the head of a department or office

Character: Tang Zhaokun, guangdong saves food medicines and chemical reagents to supervise management board medical devices to grow everywhere
Time: On December 21, 2005
Place: Guangzhou city east wind east road 753

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The development of medical devices as sunny industry is rapidder and rapidder, the effect with healthy to life life medical devices is bigger and bigger also. The stand or fall of quality of medical devices is concerning directly the patient‘s life is safe. Although any appearing on the market,the quality of the product assures the responsibility that is manufacturer, but superintend a branch as the government responsible the rights and interests that goes defending consumer. Medical devices is put in the healthy risk with potential move, the responsibility that makes the government superintends a branch consequently is more major. After before approval medical devices is used at the program of public health, be mixed, be to the method that superintends of its quality, effect, dependability and security daily or mechanism what kind of? Taking these issues, this print journalist visited Guangdong to save food medicines and chemical reagents to supervise management board medical devices to manage Tang Zhaokun the head of a department or office.

Reporter: What is the function that medical devices handles?
Tang Zhaokun: Differentiate according to what province bureau handles ventricular function, the function that medical devices handles is: Control government to medical devices lawfully; The nucleus sends medical devices to register licence of card, production, the organization carries out medical devices to produce administrative standard; Approve medical devices manages business license, harmful response incident monitors responsible organization medical devices; Advertisement of product of approve medical devices.
Reporter: The area that develops with countrywide medical devices if photograph of and other places of Jiangsu, Zhejiang, Beijing, Shanghai is compared, where is the advantage of Guangdong medical devices?
Tang Zhaokun: Guangdong is big province of industry of our country medical devices, company number discharges advanced row in the whole nation. End December 2005, guangdong province has medical devices to produce a business 1434, among them, one kind 238, 2 kinds 959, 3 kinds 237, than going up year add 150 newly; Medical devices runs a company 3993, than going up year add 722 newly. Look from structure of product of medical devices, appearance of appearance of cure of the industry of false tooth treatment of Guangdong, low frequency, biochemical reagent, custody, clinical analyzer, supersonic foundation of manufacturing industry of this kind of product is good, content of science and technology is high, the technology is mature, have quite dimensions, false tooth machines course of study to basically occupy the 60% above of countrywide market, these are the advantages of Guangdong.
Reporter: Is superintendency circumstance of Guangdong medical devices what kind of? Tang Zhaokun: Medical devices is superintended affect safety of common people life. Those who superintend is good, product quality has assure. Long-term since, we are in again will undertake spot across is checked from the following respects. It is assess to producing an enterprise to have quality system. This is the key that assures product quality, it is to strengthen superintendency main measure. 2 it is the product selectives examination. This is superintendency important step. Basically be right appear on the market product (the product of inpour market) , the product of management company, brand shop undertakes selectiving examination. If be in 2005, of 107 34 breed that we finished national make known to lower levels, products selective examination the task, involve manufacturer 143. We selectived examination to Guangdong province 210 71 kinds of products, 339 batch, enterprises. Selective examination in ours in, the product of 95% above is eligible. 3 it is to be superintended daily. We make a plan in the beginning of the year commonly, choose a target, fulfil responsibility, the limits that delimit supervises daily, content and batch, layer upon layer responsibility makes clear class of provincial, city, county class. 3 kinds of medical devices that we label key monitoring to the country are superintended daily achieve 100% , to just a little kind superintend of medical devices daily achieve 80% above, we supervised a canal to be achieved 1794 times daily 2005. Superintending daily on, city bureau is mixed in superintendency train of thought there is innovation on superintendency mode. For example, the joint meeting that superintends daily, make include production to run a company inside responsible also, responsible to product safety; Establish company record, schedule of the fundamental condition to the enterprise, certificate management, production, violate time of compasses record, examination, conclusion how, detailed notes is in archives; Executive enterprise sincere letter project, the decentralized management of sincere letter case to company product quality, sale, system, classification assess; Undertake legal laws and regulations groom to the enterprise, not not clear to plan of law of law of enterprises, seasonable, thin place, undertake explaining, transmit information, in order to enhance the legal consciousness of the enterprise and legal sense, do well manufacturing safety; Still undertake major grooms manufacturing management business management, if be in 2005, we were held 3 period system of quality of medical devices (inside careful) groom class, FDA of manufacturing quality management grooms class, FDA of management company controller grooms class, ask American FDA official to attend class, this develops train of thought to us, master a system to assess point, method, skill, safe to company product quality and product rise effectively had very big effect.
Reporter: So, where did medical devices superintend working key to be in 2006?
Tang Zhaokun: In December 2005 7-9 day, we held Guangdong to save medical devices to superintend working informal discussion in river door, the Zhang Liefu deputy director general that medical devices of be assigned personal responsibility for works was made on the meeting " fulfil superintendency responsibility, innovation superintends mode, raise medical devices to superintend a level daily ceaselessly " working report, be opposite in the report the superintendency job of medical devices did specific deploy 2006. Medical devices superintended the job to basically have tripartite side 2006: It is to should continue aggrandizement superintends the job daily; 2 it is to want to strengthen professional ability to groom ceaselessly; 3 it is to should clutch the pilot work that begins army of the person at the head of a procession and manage those who check and accept a standard to edit. This pair is advanced better medical devices superintended the job to have very important sense 2006.