Gansu, Guangdong and other 100 medical equipment business enterprises were flying seized

In September and October 2017, there were many places that would carry out flight checks on medical device operators.

The following is incomplete statistics, and the main issues summarized:

Jiuquan City Drug Administration random inspection of nine third category medical instruments Operating enterprise , The results ordered to rectify the four, for investigation and prosecution 1, seized seized to expand the scope of business operations of the third category of medical equipment 3 7 (bags, boxes).

Tianshui City Food and Drug Administration organized the city's 16 medical equipment business conducted a flight inspection, of which one in the closed state, the remaining 15 were ordered deadline for rectification.

Chenzhou City Food and Drug Administration random inspection of 22 medical devices using the unit, nine medical equipment business enterprises.As a result, the need to order rectification of the 18, need to investigate according to the law of 12, a business failed to accept supervision and inspection , Need to be dealt with according to law.

Zigong City Drug Administration random inspection of the 39 third category of medical equipment business enterprises, including 21 wholesale enterprises, retail 18. As a result, ordered to rectification 37, warning 1, a case investigation.

Autonomous regions bureau organizations on the region's medical equipment business and the use of units for the flight inspection, which Baotou City, two suspected use of in vitro diagnostic reagents and do not follow the instructions required to store medical equipment units were investigated and dealt with.

Provincial Food and Drug Administration organized a random flight inspection of 30 operating enterprises, the results ordered to rectify the deadline 23, transfer inspection and processing 1, 4 companies failed to accept the inspection, will be arranged to conduct a comprehensive inspection.

Maoming City Food and Drug Administration check the 14 medical equipment business enterprises, issued a notice of rectification 14 copies.

1, the enterprise is not in the business premises prominently placed the relevant license;

2, on-site inspection of business premises outside the signs and medical equipment business license approved the name of inconsistent;

3, the enterprise did not develop the 2017 annual training program, no training content;

4, the enterprise developed an annual training program, failed to achieve the desired training effect, practitioners of medical equipment related knowledge is not enough;

5, the enterprise staff to continue the training file content is not complete;

6, the enterprise did not according to the provisions of the relevant personnel on a regular basis health Check and establish a health file, individual exposure to medical equipment personnel health check that has exceeded the validity period;

7, business executives are not in the post;

8, the quality of the person in charge is not in office;

9, the computer system set up in the quality management staff is not full-time post;

10, the enterprise did not establish the entire process of medical equipment covering the quality management system;

11, the establishment of the corresponding quality management record system is not perfect (no product conservation, inspection and records system and other related content);

12, the establishment of the enterprise management documents incomplete (business refrigeration medical equipment, but did not establish a frozen medical device management system);

13, the enterprise quality management personnel failed to perform the corresponding duties, failed to guide, supervise the implementation of the system, and the implementation of quality management system to check, correct and continuous improvement;

14, non - acceptance of personnel to participate in acceptance work;

15, the enterprise is not equipped with full-time or part-time staff, in accordance with the relevant provisions of the state commitment to medical equipment adverse events monitoring and reporting;

16, the computer management information system is not effective operation, the computer system storage, acceptance, sales record data incomplete;

17, medical equipment warehouse classification storage is not standardized;

18, medical equipment and non-medical devices mixed, no isolation, no logo;

19, medical equipment is not according to specifications, batch number stored separately;

20, individual medical device on the local code release;

21, medical equipment storage operations area stored in other unrelated items;

22, the Treasury to be tested area, qualified area, unqualified product area, delivery area, etc. are not clearly distinguish;

23, the enterprise warehouse does not set the storage of packaging materials;

24, the enterprise storage use of the refrigerator is not verified;

25, did not follow the requirements of the warehouse temperature and humidity monitoring and recording;

26, the temperature and humidity monitoring equipment is not regularly calibrated or verified;

27, the establishment of the enterprise incubator management document content description is not accurate (verification report provides the placement of six ice, and the provisions of the document placed 18 ice);

28, the enterprise did not sign with the supplier purchase Contract or agreement;

29, the enterprise has not established and implemented the purchase inspection system, no purchase inspection records;

30, the company did the acceptance of incomplete records (lack of registration number or record certificate number);

31, spot checks on the purchase of individual medical equipment, can not provide the corresponding with the goods alone;

32, the enterprise purchased part of the medical equipment with the goods single content is incomplete (lack of production enterprise license number or product registration number, record certificate number);

33, enterprises and individual suppliers signed a procurement agreement did not agree the quality of responsibility;

34, the quality assurance agreement between the enterprise and the supplier has expired;

35, the legal power of attorney expired;

36, the computer system does not meet the requirements of the third category of medical equipment management (no purchase and sale of medical equipment operators legitimacy, effectiveness audit control function);

37, the enterprise did not establish the first business, the first varieties of audit records;

38, wholesale enterprises will be individual medical equipment sold directly to individuals;

39, to expand the scope of business operating the third category of medical equipment and other illegal issues.