Medical network - February 20 February 16 to 17, the supervision and administration of medical devices nationwide conference was held in Beijing. National drug safety bureau deputy bureau telephoto red stressed at the meeting, 2017 YiXie regulatory priorities include "strengthen medical instrument flight check and outside check".
Flight 2016 is our country medical equipments fully rolled out in the first year, then, in 2017, the medical instrument flying inspection plan?
According to the latest news, the relevant person in charge of drug safety administration of medical devices and supervision, said 2017 will arrange administration and ShengJu two level flight check, and all of the flight test results to publicly on the website.
Among them, the administration plans to overhaul 50-80 production enterprises and 20-40 enterprises, directly to four types of companies:
1, high-risk products manufacturing enterprises;
2, deal with cases involving directly by the administration of production enterprises;
3, storage and transportation management enterprise have special requirements;
4, imported product registration agent.
In 2016, the administration of drug safety a total of 23 provinces (municipalities) 51 third class medical device manufacturing enterprise to carry out the flight check. In 2017, will fly 50-80 production enterprises, flying object quantity greatly increased.
Provincial food and drug administration of the flight check objects also have 4 class:
1, the two level (country and ShengJu) sampling observation unqualified products production enterprises, to achieve full coverage checking;
2, high incidence of adverse events of production enterprises;
3, complaints to report more production enterprises;
4, the national and provincial supervision of the production enterprises involved in the directory.
In 2016, such as guangdong province also launched in view of the flight check production enterprises, but there are still many ShengJu did not fly an action. Administration of drug safety, according to the provinces to submit the case for all of last year the provinces with 142 flying inspection of production enterprises.
According to the 2017 fly inspection plan, first of all, the provincial bureau to be in 2017 or start of provincial machinery enterprise fly action.
Second, is important to note that administration will be unqualified products for sampling flew inspection task to ShengJu enterprise. And administration put forward in the 2017 YiXie regulatory focus, "big spot check will be carried out in the whole system quality and safety, increase the funds investment, expand the scale of sampling observation". Sampling will increase this year, ShengJu bear this kind of fly inspection task nature should also be increased.
Again, last year and early this year, a lot of places the new incentives for the drug to report, including the medical equipment industry illegal whistleblowers, gives the highest 300000, even 600000 reward. Under the stimulus, 2017, face machinery companies complain inform against or will increase, the corresponding action should also increase such fly at the provincial level.
As for enterprises, in 2016, and administration of medical devices circulation the timing of the big regulation violation behavior, organization to carry out the business enterprise flight check, for the first time to fly to check the total 9 provinces (municipalities) of 16 enterprises. According to the arrangement, the administration in 2017 to fly 20-40 enterprises, number is also increased.
In addition, in 2016, the administration has to account for our import market share larger 19 overseas production enterprises to carry out the inspection. In 2017, the administration plan for 20-30 overseas enterprises to carry out the production site for verification. The size of the overseas examination should also be increased.
Finally, as you known list of national and provincial medical instrument flight inspector:
Administration of drug safety in the "2017 YiXie regulatory priorities", in 2017, to accelerate the professional inspector team construction, food and drug administration bureau will also be carried out in full system examination skills training.
In early 2016, drug safety administration issued the first batch of national medical equipment inspector list, a total of 35 people. In September 2016, drug safety administration of medical devices and supervision, deputy director of the sun, according to the second batch of national medical equipment inspectors have been trained, drug safety administration of medical devices currently flying inspection team has expanded to about 100 people. However, the second list of drug safety administration has not yet released, are now known to list only the first batch of 35 people.
In addition, in place, after entering 2017, January 10, the Shanxi Province food and drug administration issued the province medical instrument inspector list over the next five years, a total of 160 people. On February 10, the food and drug administration in fujian province and released the first batch of provincial medical apparatus and instruments in the province inspectors list, a total of 54 people.
On September 1, 2016, the shandong province food and drug administration issued the province's provincial drug inspectors list, term as of June 30, 2018, a total of 84 people, across the land law enforcement in the province.
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