In the medical device industry on June 26, the flight inspection work for production enterprises is spreading across the country, and circulation enterprises are not immune.
Recently, some local pharmaceutical supervision departments have organized medical devices to operate the enterprise flight inspection. Medical instruments are in circulation and the drums are coming.
The following three places are typical:
Guangdong: thirty weapons dealers were inspected, four were shut down, three were transferred and 18 were rectification
According to the latest notice from guangdong provincial drug administration, the bureau organized the operation of medical devices in the province in May 2017.
This test involves the registration agents of 30 provincial imported medical devices and the operation of cold chain management medical devices.
Key check: enterprise quality management system is established and effective implementation, marketing channel whether standard, records are complete, cold chain transportation, storage conditions whether complete, complete record is true.
The results are as follows:
1. There are serious defects in the operation quality management of four arms dealers. They are ordered to suspend business for rectification.
Include:
Guangzhou ordis trading co. LTD
Shenzhen city health care products co. LTD
Baoshi medical products (shenzhen) co. LTD
Zhuhai great medical technology co. LTD
2. There are 18 suppliers who are not eligible for the medical GSP requirements, and are ordered to rectify the problem within a specified time limit.
Include:
Foshan aibo biotechnology co. LTD
Guangdong green health medical equipment co. LTD
Zhongshan yangda reagent instrument co., LTD
Shaoguan city lifeng reagent instrument co. LTD
Shaoguan kangpei medical services co. LTD
Shaoguan yueqi medical equipment co. LTD
Heyuan weida medical equipment co. LTD
Heyuan weikang pharmaceutical co. LTD
Shenzhen ke - kang electronic instrument equipment co. LTD
Shenzhen food hall health industry co. LTD
Shenzhen krunda biological engineering co. LTD
Zhuhai xinxin enterprise co. LTD
Zhuhai liuwei life technology co. LTD
Zhuhai senrun biotechnology co. LTD
Fisher parker healthcare (guangzhou) co. LTD
Guangzhou mendenus medical device co., LTD
Guangzhou yusheng biotechnology co. LTD
Guangzhou thick kernel medical technology co., LTD
3. The three weapons dealers are suspected of violating the regulations on the supervision and administration of medical devices and the methods of supervision and administration of medical devices, and have been transferred to the inspection department to conduct investigation and treatment according to law.
Include:
Zhongshan weitao scientific instrument co. LTD
Zhongshan yinghao medical instrument co. LTD
Shenzhen and lu yuan electronics co. LTD
4. Three other weapons suppliers are not subject to inspection and will be fully inspected according to the medical GSP requirements.
Include:
Guangzhou dai longsi medical equipment co. LTD
Zhuhai baoyanmei investment co. LTD
Heyuan xiangying medical equipment co. LTD
Sichuan province: two weapons dealers have been inspected, 1 closed for the rectification
From May 2 to 6, the sichuan provincial food and drug administration organized a medical instrument flight inspection of 12 units, including two medical devices operating enterprises. However, from the inspection results, the two weapons dealers are in violation of the medical GSP regulations.
Among them, nanchong huakang pharmaceutical co., LTD. Is a general project that does not meet the requirements of the medical GSP, and must be rectification within a specified time limit. Sichuan and medical equipment co., LTD. Both general and key projects have violated the medical GSP requirements and must be closed for rectification.
Shaanxi: after flying inspection, six weapons dealers have been banned and one business has been closed for rectification
In early June, the pharmaceutical supervision bureau of weinan city, shaanxi province, conducted a flight inspection of some medical device operating enterprises.
The results are as follows:
1. In violation of the regulations on the supervision and administration of medical devices, six disarmed dealers have been banned in accordance with the law.
Include: linwei XiaoJun conde pharmacy, linwei Sue take optician, shaanxi gloria pharmaceutical chain co., LTD. Obviously zhi forest center big pharmacy, weinan China pharmaceutical co., LTD., the new road branch, qin county lines Formosa glasses, xi 'an northwest glasses county branch.
2. Weinan jiaoli medical equipment co., LTD. Was ordered to cease all operations and suspend business operations.
3. Xiaoli hearing aid operating department of weiwei district was ordered to rectify the problem within a specified time limit.
The relevant principals of the above enterprises will also be interviewed by the drug administration department.
The operation of medical equipment, several problems common
At every level, compared with the flight inspection of medical device manufacturers, the flight test results of medical device operating enterprises can be said to be "worse".
In the past, the area of domestic medical devices has also been shown to be characterized by the disorder. This situation, however, is subject to a rigorous examination of the inspection of the drug inspection.
In 2016, the state administration of drug administration launched the first flight inspection in the circulation field of medical devices, and the flying inspection of the medical device industry was extended to the operation field. In 2017, the flight inspection of medical device operating enterprises is obvious, and it is more aggressive and wide-ranging than 2016. The flying inspection that has been launched in the above three provinces is typical.
For industry enterprises, it is not easy for the medical operation to be completely non-infraction, how to avoid? The following is a major violation of the operation of the medical equipment which was summarized by the pharmaceutical supervision bureau of weinan in the notice of flying inspection:
1. Operating without license and exceeding scope.
2. The quality leader is not in the job, in the post, and cannot perform his duties effectively.
3. Failing to audit the supplier qualification according to the regulations and supply to unqualified party.
4. The purchase and sale records are not standardized. The procurement, acceptance, sale and record of some enterprises are not complete; Individual enterprises do not agree with the supplier of quality responsibility and after-sales service responsibilities.
The management of the warehouses is chaotic, and there is a mix of stacking and mixing.
6. Change the business address without authorization.
In addition, the food and drug administration in sichuan province in flying inspection also found a key projects related to the YiXie cold-chain management: business scope is in vitro diagnostic reagents but not cold storage temperature automatic monitoring system, no generators. |
