Flying storm swept a batch of medical device companies were investigated

Medical Network January 8 hearing 2018, the medical device industry is the opening from the severe atmosphere of the New Year's Day just after the drug regulatory agencies across the country have issued a circular, there are a number of medical device companies in the flying examination 'fall' was Rectification, discontinuation and so on.

January 5, Guangxi Food and Drug Administration issued a circular, two medical equipment manufacturing enterprises in Liuzhou, because they did not pass the regional drug control department of flight inspection, was informed and ordered to suspend production for rectification.The two companies areLiuzhou, Guangxi Kang Medical Devices Co., Ltd., Liuzhou Kaifa Industrial Products Research Co., Ltd.

Bulletin said that the existence of Shengmeikang medical product release procedures did not develop, not according to the provisions of the clearing house to fill in the market record, did not confirm the sterilization process to confirm the sterilization of 24 issues and defects; Kai hair industry there is a critical process (ozone disinfection ) Of the important parameters (measurement, time, degradation) have not been verified, each batch of products failed to establish production records can not meet the retroactive requirements of 21 questions.

On January 4, Sichuan Food and Drug Administration issued a circular stating that it inspected seven medical device companies for flying tests and found that there was a problem. After they were confirmed by the enterprises under inspection, they were all handed over by the inspection team to the SFDA Sent observers.

Among these enterprises, 6 are in Chengdu and one is in Luzhou. The provincial bureau requires Chengdu Food and Drug Administration of Luzhou and Luzhou to keep track of rectification of the inspected units, and refuse rectification should follow the regulations of "Medical Device Supervision and Management Ordinance "requires investigation according to law.

These companies include:

Chengdu Shun Ya Medical Supplies Co., Ltd.

Chengdu Yi Mei Lok denture Co., Ltd.

Chengdu Kang Fu Scientific Instruments Co., Ltd.

Sichuan Hengming Technology Development Co., Ltd.

Chart Biomedical (Chengdu) Co., Ltd

Chengdu Watson Transtech Services Medical Devices Co., Ltd.

Sichuan Del Kang Medical Devices Co., Ltd.

January 3, Tianjin Market Committee issued a circular on December 26-27, 2017 flying six medical device operators.

Flight inspection found that Tianjin Development Zone Hongfeng Branch Industry and Trade Co., Ltd., Tianjin Golden arrow Trading Company, Tianjin Rich Financial Ruiyuan Technology Co., Ltd. operating quality management system there are key project flaws.

The committee requires the above three companies should immediately rectification, supervision of the area to supervise the implementation, and investigation of alleged violations of law.

In addition, Tianjin Zhongxin Pharmaceutical Group Co., Ltd. Hexi Branch, Tianjin Keno Medical Devices Trading Co., Ltd., Tianjin Shang Shikang Medical Equipment Sales Co., Ltd. operating quality management system flawed.The committee requires the above three companies should be deadline Rectification and reform, the regulatory authorities to supervise the implementation, and strengthen supervision.

December 28, Food and Drug Administration of Hainan Province has issued a circular, a total of four medical equipment conducted a flight test results, together with December 19 notice of the 8, a total of 12. Among them, a total of the following 9 companies Defective, the first four as a 'general defect', not serious, the rest are required rectification:

Hainan Koshiba source medical instruments Limited

Hainan Ke Bangda Medical Devices Co., Ltd.

Hainan Xinyuan of Medical Devices Co., Ltd.

Hainan Yulin Medical Devices Co., Ltd.

Haikou 瑅 瑅 瑷 Institute of Biology

Haikou Xinhua strong denture Co., Ltd.

Hainan Ai Ya Leyi Tooth Co., Ltd.

Hainan Hong Si Yong Thai Tooth Technology Co., Ltd.

Hainan Shibang Kang Medical Technology Co., Ltd.

In addition, there are three companies found no problems, including:

Hainan Lang Teng Medical Equipment Co., Ltd.

Haikou unlimited US medical supplies Limited

Hainan New Sunshine Pharmaceutical Co., Ltd.

January 3, Inner Food and Drug Administration announced in the news that the council for medical device operators in 2017 enterprise Of the inspection, covering the region's 12 prefectures 45 counties in 201 medical device operators, the use of units, its Chinese medicine There were 58 medical equipment enterprises and 143 medical institutions of various kinds at various levels. The CCP detected 792 illegal and irregular problems of all kinds, started 87 on-site auditing procedures and seized 27 illegal facilities on the scene.

December 14, 2017, the council held a summing-up meeting, revealed at the meeting, autonomous regions and the Food and Drug Administration will use 2-3 years to carry out centralized management of the use of medical equipment operation, to crack down on illegal activities.