CFDA announces flight inspection results of 13 medical device companies

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Careful organization, selection of personnel, locking clues, supervision and development - the State Food and Drug Administration at the end of 2016 organized the first flight inspection in the field of medical device circulation in China. The Food and Drug Administration has issued a Notice on the Inspection Results of 13 Medical Device Business Enterprises, such as Yishan Biotechnology Co., Ltd. (hereinafter referred to as the “Notice”), and announced the results of flight inspections to the public.

In June 2016, the General Administration of the People's Republic of China issued the "Notice on Regulating the Illicit Operation of Medical Devices in the Field of Circulation" (No. 112 of 2016) to carry out centralized rectification of illegal business operations in the field of medical device circulation. From November 28th to December 2nd, 2016, the General Administration of the State Council organized the backbone of the medical device supervision business to go to the nine provinces and cities for flight inspection, and to understand the implementation of the "Announcement" by local medical device operators to conduct self-inspection and rectification, etc., and urge the provinces and cities. The food and drug supervision departments in strict accordance with the requirements of the "Announcement" to carry out rectification work, severely investigate and deal with violations of laws and regulations, and ensure that the centralized rectification work is effective.

安徽印发第一类医疗器械产品备案管理新规

The reporter learned that the General Administration has locked in clues from complaints and reports, auditing case clues and cross-checking of illegal business operations in the field of medical device circulation, focusing on medical device wholesale enterprises, importing medical device domestic agents and operating cryogenic medical devices. In the business operation, 16 business enterprises were selected for flight inspection, and 8 illegal activities listed in the Announcement were mainly examined.

In conjunction with the actual situation of supervision work in the field of medical device circulation and the characteristics of supervision at the city and county levels, the General Administration has carefully screened flight inspectors. The inspectors of this survey are mainly composed of the backbone of the medical device supervision business of the Municipal Bureau. The head of the inspection team is a supervisor who has long been engaged in the supervision of medical device management enterprises and has extensive experience in on-site inspection. Some of them have participated in the circulation of medical equipment throughout the country. In the field of illegal business operations, centralized rectification and cross-checking work.

On-site inspection found that Yishan Biotechnology Co., Ltd., Guangdong Hexin Biotechnology Co., Ltd., Beijing Hantong Ruicheng Medical Devices Co., Ltd., Heilongjiang Renze Medical Devices Co., Ltd., China Resources Jilin Cornell Pharmaceutical Co., Ltd., Jiangsu Keyu Medical Device Trading Co., Ltd., Jiangsu Tide Pharmaceutical Co., Ltd., Guizhou Bijie Senyue Medical Devices Co., Ltd. 8 medical device operating enterprises have illegal business operations as described in the "Announcement", in violation of the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as "Regulations") "Measures for the Supervision and Administration of Medical Device Management" and other relevant provisions. In accordance with the relevant provisions of the "Regulations", the General Administration has requested the relevant provincial (municipal) Food and Drug Administration to file an investigation into the illegal business operations of the above-mentioned enterprises, and deal with them seriously according to law. If the circumstances are serious, the business shall be ordered to suspend business until the Medical Device Business License is revoked. Constitute a crime, be held criminally responsible. The General Administration of the People's Republic of China will supervise the above-mentioned illegal business cases.

On-site inspection found that Sinopharm Group (Tianjin) Medical Devices Co., Ltd., Tianjin Kaiwen Hengtai Technology Development Co., Ltd., BD Medical Devices (Shanghai) Co., Ltd., Roche Diagnostics Products (Shanghai) Co., Ltd., Hunan Guoke Hengkang Medical Technology Co., Ltd. The five medical device operating companies of the company do not meet the requirements of the "Quality Management Regulations for Medical Device Management" (hereinafter referred to as the "Specifications"), and the General Administration has requested the relevant provincial (municipal) Food and Drug Administration to order the above-mentioned enterprises to rectify within a time limit, and Supervise the enterprise to make correct rectifications in place.

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