Medical network - February 20
Medical devices start "two-stage" flight check
On February 16, the reporter in the "2017 national work conference on the supervision and administration of medical devices" on, in 2016, the state food and drug administration and further intensify the flight check production enterprises, to 23 provinces (municipalities) 51 third class medical device manufacturing enterprise to carry out the flight check, eight companies because there are serious defects was ordered to rectify, administration of all inspection situation in site publish special column.
For the first time in 2016, the administration has also organized to carry out the business enterprise flight check, the nine provinces (municipalities) of 16 companies on the flight check, eight companies are illegal conduct, the five problems do not conform to the management of the quality control standard for enterprise, has now asked related ShengJu processing in accordance with the law. To further expand the scale of the overseas examination, a total of 2016 organized 10 inspection group of 19 overseas production enterprises to carry out the inspection, covering the United States, Europe, Japan and other regions and countries, mainly check the object includes accounts for imported medical device market share larger manufacturers in China.
At the same time, in 2016, under the joint efforts of the regulatory departments at all levels, continues to strengthen the supervision and inspection work, specific is more serious, have more obvious. The national total inspection 29974 times of production enterprises, shall be ordered to make correction, 4433 times, filed for investigation 333, the year without significant quality safety incidents; Check management enterprise 456252 times, shall be ordered to make correction, 36925 times, 2834 a case for investigation. Regulators around the fully recognize the important role of flight check, and implementation of the various ways of flight check, and check in's official website announced the flight information. According to the provinces of statistics, announced a total 142 production enterprises inspection information.
The first year of 2016 is the flight check full-scale. National food and drug supervision and administration bureau deputy bureau telephoto red points out, "can't see the risk is the biggest risk, see the crisis is the biggest crisis. The supervision and administration of medical devices is essentially a risk management, risk prevention is the lifeline of supervision, to ensure the quality and safety of medical equipment, as well as monitoring the crackdown, but also enhance the consciousness of risk with race. By strengthen the daily supervision, will pass forward to prevent risks, from the perspective of the hot issues, the integrated use of supervision and sampling inspection, adverse event monitoring, complaints to report, a variety of means such as public opinion monitoring, ensure that the risk in the bud stage".
For 2017 work schedule and administration of state food and drug supervision and administration of the relevant person in charge of medical device supervision, said 2017 will be on the basis of summing up experience, arrange of taxation and ShengJu two level flight check. Administration of flight check will focus on high-risk products production enterprises, to deal with cases involving directly by the administration of production enterprises, storage and transportation have special requirements of business enterprise and imported product registration agent, comprehensive plans to examine 50 ~ 80 production enterprises and 20 ~ 40 enterprises; Provincial flight check for two-stage sampling observation unqualified products production enterprises, to achieve full coverage, and the high incidence of adverse events, complaints to report more involved as well as the directory for national and provincial key manufacturing enterprises to carry out the flight check. All flight test results to publicly on the website. Around to plan ahead of schedule, flight check whole process work plan, in strict accordance with the pharmaceutical medical instrument flight check method "the requirements of the work. At the same time, will continue to organize for 20 ~ 30 overseas enterprises to carry out the production site verification, and further standardize the foreign check work, strengthening inspection preparation, unified examination standard, continuous upgrading of the pertinence and effectiveness of examination.
The second category of medical device registration fee system has been in 15 provinces
On February 16, the reporter in the "2017 national work conference on the supervision and administration of medical devices" on, in order to implement the state council about the opinions of the drug review of medical equipment examination and approval system reform ", Beijing, liaoning, Shanghai, zhejiang, hunan, guangdong and other ShengJu successively introduced for innovative medical devices and other special preferential measures for examination and approval, optimize and simplify the procedure of the second category of medical device registration. At present, there have been 15 provinces has implemented a system of registration fee, has yet to implement the registration fee of provinces are also coordinate with local authorities, actively promote the related work.
According to statistics, as of the end of 2016, the state food and drug supervision and administration bureau received 488 innovative medical devices for examination and approval of special application, complete the review, 461, 89 products into the innovation of medical equipment for examination and approval of special channel. Has approved the orthopaedic surgery navigation and positioning system, such as rf cold saline infusion ablation catheter 20 products listed. Among them, the global initial approval of pulmonary artery with disc pipe to fill the domestic blank in the field of medical apparatus and instruments high-end artificial biological heart valve.
In addition, in the further scientific and rational setting of medical equipment requirements based on clinical evaluation, on the premise of ensuring safe and effective, the administration also released the second batch of from conducting clinical trials of medical equipment directory, on 267 kinds of the second category of medical equipment, 92 kinds of class iii medical devices, total 359 species of medical equipment products from clinical trials. Among them, there are 15 kinds of products in vitro diagnostic reagent, which is in vitro diagnostic reagent products for the first time listed in the directory from clinical trials.
JiaoGong pointed out that over the past year, review of medical equipment examination and approval system reform work promoting. According to the state council "about the opinions of the drug review of medical equipment examination and approval system reform, and actively take effective measures to catch up together. Aiming at the problem of registration data quality is not high, strengthening the technical review guidelines, further refine regulations, clear requirements; Aiming at the shortage of technical review power, speeds up the technical evaluation institutions and personnel system reform, the hiring side personnel full force, and utilize the expert resources, use the "mind" for regulation services; For review of quality problems, to strengthen the construction of quality management system, develop a good review of the quality control standard, improve the communication system, set up a review committee of experts, to carry out the joint review panel, Aimed at the problem of insufficient innovation power, medical equipment industry has launched "innovation medical instrument special approval procedures" medical equipment preferred examination and approval procedures, encourage the innovation of medical equipment, further meet the demand of medical device in clinical use. In view of the clinical trial data is not standard, the problem of untrue, incomplete, conducting clinical trials selectives examination; Aiming at the problem of medical device regulatory foundation weak, tracking international, strengthen the transformation of the international standard, promoting medical devices standards revision and classified management reform, promote the industry as a whole level of ascension; Against the problem of the missing import medical equipment the inspection, to strengthen foreign production quality system verification, risk prevention and control imported medical devices.
JiaoGong said. "medical apparatus and instruments for examination and approval of the review is listed the first, the quality of products is a key link in the process of the supervision and administration of medical devices. Review of the examination and approval system reform, improve the review to examine and approve the quality and efficiency, to promote medical equipment product quality, promote the reform of supply side structure is of great significance".
JiaoGong requirements, in 2017 to further deepen the reform, perfecting the mechanism, improve efficiency. We will continue to review the quality management system construction, strengthen the supervision and evaluation, and implement the responsibilities for quality control. Strengthen the technical review guidelines system research, increase the intensity of work, improve the guiding principles for coverage. To further improve the mechanism of the innovation review, well implement priority for examination and approval system, to better meet the requirements of medical devices for clinical use. Further simplify optimization continuation of registration, alteration registration process and declare information requirement, the optimization of medical instrument clinical evaluation method, continue to expand product range from clinical trials, raise the scientific nature of the regulation. Expanding the scope of the new review of running mode, and gradually establish a clinical as the guidance, the review as the core of the evaluation system for project team. Establish expert advisory committee, perfect communication system and technology system of dispute resolution. Vigorously strengthen the supervision and administration of medical devices clinical trials, research and clinical trials to establish institutions for the record management system, to expand the clinical test units. Further strengthen clinical trial process supervision, to carry out clinical trials and the quality control standard for inspection, on the implementation of the related problems. Continue to carry out product development, clinical trial samples and authenticity verification of registration data, to crack down on false declaration violation behavior, such as play a deterrent.
JiaoGong stressed that the work will continue to promote the reform of classification management, establish category dynamic adjustment mechanism, risk evaluation of medical equipment in a timely manner. Steady progress was made in medical instrument standard, naming, coding and other basic work, improve the system of medical instrument standard management, strengthen the research into the international standard. Deepen the reform, to promote the implementation of the government purchasing service policy. Administration will continue to strengthen the guidance of the provincial medical instrument examination review ability construction, comprehensive evaluation, the technical evaluation ability can not meet the requirements, administration introduced to study the corresponding measures. |
