Medical network - on November 23, near the end of the year, 2016 medical instrument flight tests are not only didn't stop, instead of growing.
State food and drug administration continues to release new for domestic medical device manufacturing enterprise fly inspection notice, to foreign machinery of fly also will come at any time.
In place, in the fourth quarter, several provinces of the nation's food and drug administration started the flight inspection work of medical equipment, scope of inspection is production enterprises, trading enterprises, medical institutions. Among them, fly against the hospital inspection, the agency has become more common to choose from.
Country: two machinery company was shut down again, the year has been flying 51
On November 22, the state food and drug administration issued notice, two medical device manufacturing enterprise for production quality management system, there are serious defects was ordered to close immediately rectification, and the province food and drug administration for its violation behavior serious processing.
At this point, the state food and drug administration in 2016 has been completed fly 51 domestic medical device manufacturing enterprise, eight of them flew detected in 10 months. Administration of years will also be of 19 overseas medical device manufacturing enterprise to carry out the flight check.
Latest inspection, production of 2 companies are suzhou kt blue eye care products co., LTD and chengdu constant wave medical instrument co., LTD. Their main problems are as follows:
A, suzhou kt blue eye care products co., LTD
1, turning, demoulding operators are not familiar with to relevant requirement, not according to the work instructions operation, no pre-service training record;
2, cannot provide in February 2016 after the clean room air conditioning system in the efficient filter and high efficiency filter corresponding to replace or leak detection records;
3, the main raw material stock number does not agree with the corresponding material card to record the material number, intermediates warehouse intermediates materials card not recorded in the batch number;
4, don't provide the one-time pressure steam sterilizer sterilization validation report;
5, to provide product release process, conditions and release approval required documents;
6, nonconforming product control, do not accord with YiXie GMP requirements;
7, not to the related national supervision to sample unqualified products for management review.
Medical equipment co., LTD., chengdu constant wave
1, not equipped with the product inspection requirements that meet the needs of testing instruments and equipment;
2 on January 24, 2016, enterprise product design changes and to implement, but the relevant process documents on June 1, 2016 to make the change, on September 2, to implement a design change again, but not yet change corresponding process documents;
3, check the products of this enterprise, its main components in the production process card is not clear raw material batch number, do not back;
4, product specification of product inspection in the leakage current test code requirements and product registration standards specified in the wet pretreatment was carried out on the leakage current do not match the inspection requirements before and after wet pretreatment; Actual product release approval person and enterprise departments and personnel responsibilities and authorities in the quality manual clearly do not match the personnel responsible for product release audit.
Local bureau: guangdong, zhejiang, sichuan, hubei, hunan, shandong...
The state food and drug administration of overweight fly inspection at the same time, guangdong, zhejiang, hubei, hunan, shandong province is a provincial medical devices at the same time big flying inspection work.
A, guangdong: machinery, hospital to meet at the same time to fly
On November 7, 2016 medical equipment management enterprise of guangdong province flight check officially kicked off, for two weeks, in shantou city has four medical equipment management enterprise accepted ShengJu fly inspection team.
Fly the inspection scope includes the legal qualification of enterprise, warehouse management, cold chain transportation, quality tracking, personnel training, the previous inspection found defects and other problems are corrected to carry out the six aspects, such as, the key is the management of the enterprise in cold chain transport and cold storage monitoring link.
At the same time, the food and drug administration of guangdong province launched in view of the hospital medical instrument flight inspection work.
On November 10, the provincial food and drug administration chief LuoWenZhi has led to guangzhou medical devices using link supervision inspection work and research. LuoWenZhi personally randomly selected two hospitals as the inspection object.
The first people's hospital in guangzhou, inspection team review the incoming inspection system of medical consumables, storage conditions, and traceability.
In the first affiliated hospital of guangzhou medical university, the team review the quality of first aid equipment safety and maintenance of large medical equipment as well as the traceability of the large medical equipment inspection records.
Second, the hunan province: 12 machinery, YiXie GMP inspection
On October 28th October 24 solstice, hunan province food and drug administration transferred inspectors of four inspection team, the province 12 medical device manufacturing enterprise to carry out the flight check.
The scope of the hunan province food and drug administration the flight check all is "medical equipment production and the quality control standard for the whole project execution check", the results are as follows:
1, Brahms biological pharmaceutical co., LTD., hunan province, rectification within a time limit;
2, hunan yi min sun technology co., LTD., rectification within a time limit;
3, hunan health medical equipment co., LTD., production;
4, hunan on medical technology co., LTD., rectification within a time limit;
5, changsha vander-waalsforces biological technology co., LTD., rectification within a time limit;
6 biological medical technology co., LTD., hunan iresearch, quasi cancellation of medical equipment production license;
7, hunan xu feng medical equipment co., LTD., is proposed to cancel the production license;
8, hunan eter electronic medical engineering co., LTD., rectification within a time limit;
9, hunan than oxygen industry engineering co., LTD., is proposed to cancel the production license;
10 sincerely pharmaceutical machinery co., LTD., hunan, is proposed to cancel the production license;
11, hon of yiyang city medical equipment co., LTD., rectification within a time limit;
12, hunan yuan care equipment technology development co., LTD., to cancel the production license.
Three, in hubei province: IVD companies flight check after production
On October 22 to 23, to wuhan hubei province food and drug administration is still appropriate healthcare technology co., LTD. Check for the flight.
Inspection found that 11 by enterprise is not in conformity with the quality management for medical equipment production specification requirements, quality management system defects. And 1 of them illegal key rules. On October 23, 2016, in the enterprise, according to the production and the hubei province food and drug administration order of wuhan food processing in accordance with the law.
Four, in shandong province: 38 high-risk machinery companies were flying inspection
Recently, the shandong province food and drug administration of creating 19 inspection for 38 high-risk medical device manufacturing enterprise in the province flight check, this also is the province's annual fly screening machinery enterprise.
This check involved disposable infusion apparatus, orthopedic implants and intrauterine device, corneal contact lens and so on six big products. Scope of inspection for the whole project quality system inspection, for procurement, clean room (area) control, sterilization process control, product inspection and product traceability key link.
Five, zhejiang province, the provincial hospital inspection, civilian battalion hospital and check
In September, October 11 cities of the whole province medical equipment management enterprise flight after inspection, the zhejiang province food and drug administration organization launched the provincial medical devices using a flight check again.
November 1 solstice 3, inspection group a line of three people in jiaxing, has examined the south lake district central hospital, xinan international tongxiang city first people's hospital and the hospital (private hospitals).
Inspection group selectived examination, clinical laboratory, three hospitals for dental emergency rooms, video branch, operating room scene, such as key verification in medical equipment procurement, acceptance, storage, maintenance and so on each link whether there is any violation of the medical device using the measures for the administration of quality supervision.
In addition, as sichuan, for instance in the recently held a medical instrument used in guangyuan city link flight inspection pep rally. Then, a few days ago, wangcang county hospital of traditional Chinese medicine and so on for the first time accepted medical instrument flight check, inspection mainly covers the operating room, clinical laboratory, radiology department, especially the large equipment, one-time consumables manufacturer qualification, procurement warehousing procedures, etc.
Zhenjiang, jiangsu province, the city food and drug administration from October 17 solstice 30, to the city's medical devices use unit for flight check.
Guizhou province food and drug administration also in September to October, the province within the scope of production and management, the link of medical equipment are checked. Results 1 production enterprise production improvement, a rectification within a time limit; Nine enterprise rectification within a time limit, eight investigation, two cancellation; Five unit using rectification within a time limit.
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So many places in YiXie fly, are you ok?
If the local food and drug administration for medical device operation enterprise flight check, or administration as a focus in the second half of the work of "medical equipment circulation violation behavior regulation" the topic of; The local food and drug administration for medical device manufacturing enterprise and the flight check of units used, the focus in the near future, means that the national YiXie unfolds have begun to fly.
Flight check, become more and more local drug safety supervision of medical device industry. Especially for medical institutions to use link flight check, for the first time in many places, many hospitals accept for the first time in the future is expected to complete normalization, the hospital is no longer a safe haven. |
