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Shandong orders 13 medical apparatus enterprises to suspend production

2017/12/5 16:46:19   source:Sdchina.com

A press conference was held Tuesday to brief on the current situation of 2017 medical apparatus campaign and the three-year special rectification action. In 2017, inspections have been carried out in more than twenty thousand enterprises and units engaged in the manufacturing, sales and usage of medical apparatus, among which 13 enterprise were ordered to suspend production. The qualification rate of sampling inspection of medical apparatus has been steady at 95% in the past two years.

Shandong has conducted inspection of 152 medical device manufacturers, 13,550 medical device operators and 8,675 medical device users, among which as many as 2,770 relevant enterprises and units were warned and ordered to make rectification and 13 were ordered to suspend production, concerning fined or confiscated money 8.08 million yuan, according to Liao Fayin, vice director of Shandong Food and Drug Administration. 146 out of the 151 lots of products needed to be inspected have been finished in the special inspection move. 6 lots of faulty products mean that 4% are not up to the standard.

Since 2015, Shandong has carried out special action on supervision and administration for medical devices for three consecutive years. The action mainly targets at seven kinds of products and experiential marketing to crack down the illegal behavior such as producing or selling unlicensed products, producing counterfeits, selling or using unlicensed products and manipulating logos and labels in instruction books. Besides, enterprises are urged to fulfill their main responsibility to prevent systematic and regional quality safety incidents. In the past three years, a total of 842 manufacturing enterprises, 33,631 trading enterprises and 38,846 users of medical apparatus have been inspected, among which 8,571 were warned and ordered to make rectification and 1,039 were ordered to suspend production, fined or confiscated about 49.994 billion yuan.

By far, 92.7 percent of Class III medical apparatus manufacturers have passed the inspection by the Medical Apparatus Production Quality Management Standard while a majority of Class II and Class I medical apparatus manufacturers have passed the inspection (still underway).

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