The medical device of the medical device on September 4, the active recall of medical devices, has always been a foreign company to do, the recall of domestic weapon enterprises is rare, a few are not visible.
But that is changing.
The new medical device recall management method comes into force on May 1 this year, one of the obvious changes in the industry is that the domestic armed enterprises have also moved to the initiative to recall.
In July and August 2017, the domestic medical equipment of the leading enterprises, shenzhen mairui biological medical electronic co., LTD., and its subsidiary mindray biological technology co., LTD., nanjing reporting recalled 4 product.
Shenzhen meirui recalled its production of multi-functional electrode (defibrillation monitor accessories), automatic blood cell analyzer; The company recalled its production of blood cell analysis using diluents, blood cells and hemolytic agents.
All four products are active recall, and the reason for the recall is "label or instruction printing error", rather than the quality of the product itself.
We take on May 1, 2017 recall of the implementation of the new rules for the point in time, found that after incomplete statistics so far is voluntarily recalling the products in the domestic machinery enterprises (foreign investment to build factories in China not) include:
1. Shenzhen anke high technology co., LTD., because of the wrong printing and production date, recalls the X-ray computer system.
2. Anhui xiaoshan health materials co., LTD., because the base material is suspected to be inconsistent with the product registration certificate information, recalls the medical surgical film products.
3. Anhui hefei and elshi technology development co., LTD., recalling the electric hydraulic multi-function operating table due to the problem of nameplate and instruction.
4. Anhui aerospace biotechnology co., LTD., recalling the pulse pressure pneumatic treatment instrument due to the application scope identification problem.
5. Zhejiang jinhua city jingdi medical supplies co., LTD.
6. Chongqing one heart hall co., LTD., recalling the nano-acupoint post due to the product label problem.
7. Hunan hongxing city zhengxing medical instrument factory, because of the scale line of the problem, recalled the thermometer.
8. Hunan hua fu medical device technology co., LTD., recalled the artificial nasolacrimal duct due to the untimely update of labels and instructions.
9, hunan changsha than young medical equipment co., LTD., due to external markers, net power connector and equipment power input pin, audible alarm signal does not conform to the prescribed standards, the recall of infusion pump.
10. Shanghai xiong bo precision instrument co., LTD., because of the product specification, recall the optometry.
11. Shanghai xiao bo science and technology development co., LTD., recalled medical inducement bone matrix due to the unqualified product supervision and test loading quantity index.
12. Sanke medical equipment co., LTD., nanning, guangxi, recalled ultrasonic atomizer because of the label problem.
13. Guizhou angel medical equipment co., LTD., because of "suspected illegal production" and other reasons, recalled the use of sterile rubber surgical gloves, absorbent cotton gauze and medical surgical masks.
In addition, at the beginning of this year, fujian province xiamen nanlong technology co., LTD., according to the newly implemented industry standard requirements, recalls the electromagnetic compatibility of the defective multi-channel ecg collection instrument. This is also the first medical device production enterprise in fujian province to carry out an active recall of the problem products.
All of the above mentioned active recall information from domestic weapons companies can be seen, because of the label, the problem of recall of the most, only a few because of the problems of the product itself, or the production of illegal production.
And the machinery enterprise represented by mindray, behind its voluntary recall, also is not by the drug safety quality sample find out problems, or check out the problem, not by drug safety shall be ordered to recall.
Voluntary recall of domestic machinery enterprises increased significantly in the near future, throughout the country provinces, it shows that domestic machinery enterprises are also changing attitude, with a sense of market, to the user more responsible behavior, improve the image of the domestic medical equipment problems.
Of course, there is no denying that, with foreign machinery companies are generally normalized by a vast, timely is voluntarily recalling domestic machinery enterprises on the voluntary recall or too little, it is a long way in the future.
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