Medical network on December 6 - guangdong food and drug administration organization carried out since November 7, 2016 annual medical equipment management enterprise flight check, the result in just over a month so far, the province has six companies were ordered to stop business operations for rectification, 36 were ordered to make correction.
The fly of guangdong province for engaged in cold chain management of medical equipment management enterprise, focusing on content has four: the enterprise the management main body, the product and personnel qualification meets the requirements; Whether to establish quality management system and strict and effective implementation; Cold chain storage and transportation conditions is complete; Marketing channel is complete specification, all the records are in, etc.
From the flight check, most of the enterprise can be in accordance with the law, the compliance management. But there are 6 companies, with key project does not meet the requirements, or do not conform to the requirements of general project number > 10%, and be ordered to stop business operations for rectification; There are 36 enterprises, general project does not meet the requirements of the number of 10% or less, be ordered to make correction.
Closed for enterprise list:
1. Guangzhou hermann medical equipment co., LTD
2. Guangzhou Kang Cheng medical instrument co., LTD
3. Foshan di Wallace trade co., LTD
4. Zhongshan zhongjing medical instrument co., LTD
5. Jiangmen Mr Medical instrument co., LTD
6. Chaozhou day cheng pharmaceutical co., LTD
The rectification within a time limit companies list:
1. Guangzhou health medical technology co., LTD
2. Guangdong jinpeng medical instrument co., LTD
3. Guangzhou guangdong au biological technology co., LTD
4. Guangzhou is steel trade co., LTD
5. Guangzhou clinical medical instrument co., LTD
6. Zhuhai lian Po pharmaceutical co., LTD
7. Zhuhai zhongshan d contour pharmaceutical co., LTD
8. Zhuhai cumming pharmaceutical co., LTD
9. Zhuhai Deere biological engineering co., LTD
10. The shantou special economic zone longhu half a continent reagent co., LTD
11. Shantou times, medical equipment technology co., LTD
12. Guangdong antell pharmacy co., LTD
13. Shantou shun kang medical instrument co., LTD
14. Rhea, foshan medical product development co., LTD
15. Foshan city kangpu pharmaceutical co., LTD
16. Guangdong hui morning medical technology co., LTD
17. Shaoguan city kang medical instrument co., LTD
18. Meizhou city hui long medical instrument co., LTD
19. Meizhou city raw pharmaceutical co., LTD
20. Meizhou city jin hong biotechnology co., LTD
21. Zhongshan biological engineering co., LTD
22. Guangdong Mr Kony medical instrument co., LTD
23. Guangdong medicine jiyuan hall pharmaceutical co., LTD
24. Jiangmen mercy medical instrument co., LTD
25. Zhaoqing city kang medical instrument co., LTD
26. Zhaoqing city hua tuo trade development co., LTD
27. Guangdong hua yu pharmaceutical co., LTD
28. Guangdong di optimal trade co., LTD
29. Qingyuan city homologous medical instrument co., LTD
30. Chaozhou xiang jin pharmaceutical co., LTD
31. Guangdong cape biotechnology co., LTD
32. Guangdong qi China medical equipment co., LTD
The age of 33. Guangdong pine pharmaceutical co., LTD
34. Guangdong ring, health medical equipment co., LTD
35. Guangdong Kang Baoyuan pharmaceutical co., LTD
36. Guangdong shunde neutral pharmaceutical co., LTD
Cold chain management: the new drug safety check focus
Guangdong food and drug administration of the inspection, once found to more than 40 existing problems of enterprise, and all is engaged in the business have cold-chain transportation, storage, visible cold-chain management YiXie important weak link of management, and has become a new drug safety check point.
In fact, since this year, the agency's emphasis on cold chain management of medical equipment is also growing. In the first half of this year, before and after the outbreak of shandong vaccine series case, at least half the provinces has successively carried out cold chain management of medical equipment supervision and inspection; Officially released the second half of the year, the administration of drug safety and medical equipment cold chain (transportation, storage) management guide ", and will be implemented from the date of release.
And drama of the year of the state general administration of drug safety, medical apparatus and instruments circulation field, illegal conduct regulation YiXie cold-chain management also regulation as the key object is carried out.
When performing announcement no. 112, all over the country also has a lot of in vitro diagnostic reagents related directly to enterprise (temperature sensitive products, cold chain foundation weak) as a cross check or flight check the focus of the object.
The guangdong province directly aimed at YiXie flight check of cold chain management, carrying out the administration announcement no. 112 is also a big reason.
As a big province of medical equipment, guangdong to fly only targeted inspection highlights YiXie cold-chain regulatory attention. And in the future, as the IVD industry has become the hot favourite going into the throughout the country the agency for YiXie cold-chain management supervision and inspection, should also will more and more, more and more powerful. |
