With the rapid development of the medical device industry, the 2002 edition of the original catalogue has been unable to meet the new needs of the development of industry and supervision. The new "directory" will be released after the change of medical devices according to the risk analysis, scientific judgment on the part of the dynamic adjustment of product management category, and promptly announced, the realization of China's medical device classification accuracy and scientificThe newly revised catalogue of medical devices will be implemented in August 1, 2018 by the State Food and drug administration.“ medical equipment classification management based on the degree of risk is an important basis for the whole process of medical equipment registration, production, operation and use. ” State Food and drug administration device registration Secretary Wang Zhexiong introduced the classification management of medical devices is the international management mode, in accordan...
September 26th, the Yunnan provincial food and Drug Administration issued the fourth 2017 medical device quality bulletin. Among them, by testing project does not meet the standard requirements of medical products, involving 1 medical equipment manufacturing enterprises of the 1 varieties of 19 batch products; testing items all meet the standard requirements of medical equipment products involving 17 varieties of 215 batch of medical products.To find the sample of the product does not meet the standard requirements, Yunnan province food and Drug Administration food and drug supervision departments should be based on "medical equipment supervision and management regulations" (State Council Decree No. 680th) for processing. The relevant state and municipal food and drug administration to urge enterprises to find out the reason as soon as possible, develop corrective measures and rectification in place on schedule, the investigation and handling of cases in October 30, 2017 to the public ...
In September 27th, the 2017 Hebei (Shijiazhuang) International Medical Equipment Exhibition (fall) was launched in Shijiazhuang International Expo center. The picture shows the special electrocardiograph for children. Reporter Yan meters ZesheHebei news network September 27th news (reporter Mi Yanze) “ this is listed in July this year a special pattern of children's crying children ECG machine, original ECG algorithm, an effective solution to the interference generated in the children crying and artifacts, provided the scientific basis for clinical diagnosis of children. ” today, held in Shijiazhuang International Expo Center, 2017 Hebei (Shijiazhuang) International Medical Devices Exhibition (Autumn), exhibitors Wuhan Gengyun Bio Medical Electronics Co., sales manager Lu Chao, told reporters on their latest products.In September 27th, the 2017 Hebei (Shijiazhuang) International Medical Equipment Exhibition (fall) was launched in Shijiazhuang International Expo center. The ...
In September 21st, the food and Drug Administration organized the medical quality management and regulations on the use of tour activities, more than two hospitals in the city, vice president in charge of equipment department (Office) or medical engineering, inspection department responsible person and within the jurisdiction of the county (city, district) medical device supervision market supervision department staff a total of 93 people came to listen. 'deputy researcher Zhang Yi attended the meeting.The speaker is the medicine of Fujian province Nanjing Fuzhou Military Region General Hospital, Fujian Medical University Affiliated Xiehe Hospital, medical engineering experts, tour content including medical equipment quality management regulations using quality management practice and interpretation of medical etc..
Medical equipment sector is a sunrise industry in the pharmaceutical industry, while China is also the world's second largest medical equipment consumer market, but from the point of view of equipment consumption, China is only 40% of developed countries. From the perspective of industrial structure, China is in the middle and low end of the global industrial chain. Under the policy guidance, along with the technical breakthrough and the use popularization of the domestic high-end products, the long term investment logic of our country's medical equipment import substitution will continue to exist.From the two market performance, the current medical equipment sector valuation in the past 3 years in the history of low areas. From the industry perspective, in recent years the leading medical device companies to achieve technological breakthroughs, to honor the results uncertainty is high, more factors and control health care costs for domestic medical equipment selection and ...
In September 21st, the food and Drug Administration organized the medical quality management and regulations on the use of tour activities, more than two hospitals in the city, vice president in charge of equipment department (Office) or medical engineering, inspection department responsible person and within the jurisdiction of the county (city, district) medical device supervision market supervision department staff a total of 93 people came to listen. 'deputy researcher Zhang Yi attended the meeting.The speaker is the medicine of Fujian province Nanjing Fuzhou Military Region General Hospital, Fujian Medical University Affiliated Xiehe Hospital, medical engineering experts, tour content including medical equipment quality management regulations using quality management practice and interpretation of medical etc..
