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Eight Top Events of Medical Devices in 2014

时间:2015-11-11 11:27:06

Looking back on 2014, my country's medical device industry has had too many gains and joys worth summarizing and reviewing. Today we will take stock of what policies are bathed in the medical device industry in 2014.


Keyword 1: "Special Approval Procedures for Innovative Medical Devices (Trial)" is released


On February 7, the State Food and Drug Administration issued the "Special Approval Procedure for Innovative Medical Devices (Trial)", giving priority to innovative medical devices.


Key word two: carry out the special action of "five rectification" of medical equipment


The General Administration of the People’s Republic of China has decided to carry out a five-month special action on medical device “five rectification” starting from mid-March. Kind of behavior.


Keyword 3: "Regulations on the Supervision and Administration of Medical Devices" promulgated


On March 31, the newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") were promulgated and came into effect on June 1. The "Regulations" added a lot of content to support the development of the industry, and appropriately relaxed the requirements for medical device research and development, aiming to actively promote the upgrading and innovation of medical device products. Classified management of medical devices according to the degree of risk is implemented, the first category of medical devices is changed to product filing management, the second and third categories of medical devices continue to implement product registration management; the first category of medical device production is changed to filing management, and the second category , The third-class medical device production continues to be subject to approval management; the operation of the first-class medical device is liberalized, the second-class medical device business is changed to record management, and the third-class medical device business continues to be subject to licensing management; clearly implemented The new supervision model of "product registration first, then production license".


Keyword four: selection of excellent domestic medical equipment


On May 26, the National Health and Family Planning Commission commissioned the China Medical Equipment Association to start the selection of the first batch of outstanding domestic medical equipment products. Select a batch of excellent domestic medical equipment, form an excellent product catalog, and gradually establish a scientific evaluation system for the application of domestic medical equipment to provide reference for the equipment work of national health and family planning institutions.


Keyword five: "Medical Device Registration Management Measures" and other five regulations are issued


On July 30, in order to cooperate with the implementation of the “Regulations”, the State Administration of The five rules and regulations of the “Administrative Measures” and the “Administrative Measures for the Supervision and Administration of Medical Device Operation” were all implemented on October 1, 2014.


Keyword six: focus on promoting the use of domestic medical equipment in tertiary hospitals


On August 16, a conference on promoting the development and application of domestic medical equipment was held. Li Bin, director of the National Health and Family Planning Commission, said that he will focus on promoting the use of domestic medical equipment in tertiary hospitals; Miao Wei, Minister of Industry and Information Technology, said. An incentive mechanism for actively using domestic medical equipment will be established.


Key words seven: "Medical Device Operation Quality Management Standards" released


On December 12, in order to strengthen the quality management of medical device operation, standardize the operation and management of medical devices, and ensure the safety of the public’s use of equipment, the State Administration of China formulated the "Quality Management Standards for Medical Device Operation" in accordance with relevant laws and regulations, since the date of promulgation From implementation.


Keyword eight: medical device clinical trial institutions will uniformly identify qualifications


On December 17, the State Administration issued the "Administrative Measures for the Qualification Accreditation of Medical Device Clinical Trial Institutions" (draft for comments). The draft for solicitation of comments is clear that the State General Administration of China, in conjunction with the National Health and Family Planning Commission, is responsible for the qualification management of clinical trial institutions for medical devices across the country.


Source: China Medical News, deleted

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