Raid check! Well-known medical companies were investigated, many were discontinued!

Medical network October 23 raid inspection! Four armed enterprises were discontinued and corrected state-level flight inspection, is the state-level inspection team thousands of miles to attack the surprise inspection, the purpose is to point out the enterprise problems, urge enterprises to carry out continuous improvement of the production quality management system.
October 20, the State Drug Administration issued a notice on flight inspection of four enterprises, including Qinghai Densta Medical Devices Co., Ltd. (No. 71 of 2020).
Qinghai Densta Medical Devices Co., Ltd., Zhejiang Jinhua Monday Biotechnology Co., Ltd., Shenzhen Haibo Technology Co., Ltd., Beijing Fu Philharmbo Technology Development Co., Ltd., 4 enterprises due to the quality management system is seriously defective, does not comply with the relevant provisions of the medical device production quality management norms, the State Drug Administration has ordered the above-mentioned enterprises to immediately stop production and rectification.
Those involved in violation of the Regulations on The Supervision and Administration of Medical Devices and related laws and regulations shall be dealt with seriously in accordance with the law, and the provincial drug regulatory authority of the territory shall order enterprises to assess product safety risks and recall the relevant products in accordance with the provisions of the Measures for the Administration of Medical Device Recalls.
from the contents of the Notice, the above four medical enterprises have institutional and personnel aspects, quality control aspects, production management aspects, equipment and other related issues.
to the National Bureau! Well-known medical companies were also investigated on the 13th of this month, the State Drug Administration Verification Center issued the "Medical Device Flight Inspection Notice (No. 2 of 2020)."
the verification center of the State Drug Administration organized the flight inspection of medical device manufacturers from August to September 2020 and found that 13 medical device enterprises had problems that did not conform to the Code of Quality Management of Medical Device Production and related appendixes.
112 defects were found in 13 arms companies.
13 enterprises tested by the air summary of the problems found in the inspection, the above-mentioned circular requires the relevant provinces (autonomous regions, municipalities directly under the Central Government) Drug Administration should be tasked with enterprises within a time limit for rectification, requiring enterprises to assess product safety risks, may lead to safety hazards, should be in accordance with the "Medical Device Recall Management Measures" provisions of the recall of related products.
the enterprise completes the rectification, the relevant provincial drug regulatory authority shall promptly organize a follow-up review and submit the follow-up review to the Food and Drug Audit and Inspection Center of the State Drug Administration in a timely manner.
This flight inspection involves Shandong Ryantai Medical Technology Co., Ltd., Shandong Jiwei Medical Products Co., Ltd., Guizhou Fine Arts Dental Technology Co., Ltd., Changchun Boxun Biotechnology Co., Ltd., Chengdu Qilin Technology Co., Ltd., Sichuan Aerospace World Guidance Co., Ltd., Beijing Bonsai Technology Co., Ltd., Yunnan Dehua Biopharmaceutical Co., Ltd., Guangdong Ahid Pharmaceutical Co., Ltd., Hebei Ruihe Medical Devices Co., Ltd., Omron (Dalian) Co., Ltd., Sanxiang Biotech Co., Ltd.
Omron (Dalian) Co., Ltd., a domestic subsidiary of Omron, whose medical molecular sieve oxygen machine was examined and found to generally do not comply with item 6.
the foreign giant's domestic subsidiary, the flight inspection was found to be a problem, the impact on it is not small.
this also gives enterprises a wake-up call, increase the self-examination of all links, it is very important.
58 more state inspectors! The increase in the frequency of raid inspection is not difficult to find, since the opening of the provincial inspection teams have increased the frequency of inspection, increase the province's production enterprises, operating enterprises and terminal hospital inspection.
this is precisely because last year, the State Drug Administration issued "on the establishment of professional professional drug inspectors of the opinion."
document emphasizes that professional and specialized medical device inspectors refer to personnel who, as determined by the drug regulatory department, conduct compliance confirmation and risk determination on the places and activities of the management relative engaged in drug development and production in accordance with the law.
specifically, the State Council regulatory departments of the main medical device research and development process on-site inspection, from the medical device clinical trial quality management norms implementation compliance inspection.
to undertake overseas on-site inspection of medical devices and major cause checks in the production process.
inspection of the main medical device production process of the provincial drug regulatory department, as well as the compliance inspection of the implementation of the relevant production quality management norms.
provincial departments will also conduct on-site inspections of medical device wholesale enterprises, retail chain headquarters, and third-party platforms for Internet sales.
can be seen that the country for the field of medical devices in all aspects, all channels have been deployed.
not long ago, the State Drug Administration once again published a new batch of "on the appointment of the fifth batch of national medical device inspectors list."
58 people were hired as the fifth batch of national medical device inspectors, distributed in a number of provinces throughout the country.
the future there will be more national prosecutors rushed to all parts of the country, this does not say hello straight to the scene of the inspection frequency will be higher and higher!