2.Contemplation and suggestion on the medical device adverse event reporting program.
Baodong YU ; Yingjie GUAN ; Xiaomei MO
Chinese Journal of Medical Instrumentation 2014;38(1):65-67
The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.
China
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Consumer Product Safety
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Equipment and Supplies
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Safety Management
4.Analysis of the security risk in home medical equipment.
Xiaolong PENG ; Honglei XU ; Xiaojun TIAN
Chinese Journal of Medical Instrumentation 2014;38(1):71-74
The popularization of home medical equipment facilitates the treatment and management of many diseases, improving the patient compliance. However, due to the absence of medical background, most of their users have various security risk in the course of reorganization, choosing, using and maintenance of the products. This paper analyzed the property of security risk in home medical equipment, and described the matters needing attention in the using of several common products.
Consumer Product Safety
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Equipment and Supplies
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Household Articles
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Risk Assessment
7.FDA Premarket Pathways for Combination Products.
Chinese Journal of Medical Instrumentation 2022;46(4):355-360
Combination products face unique R&D, manufacturing, clinical, and regulatory challenges compared to individual devices, drugs, or biological products. Based on the interpretation of the relevant policies and the latest principles of combination products, this paper expounds the FDA's guidance, application trends, and application strategies for the pre-market pathways of combination products, with a view to providing relevant information for Chinese researchers and manufacturers when they start to entry the United States market.
Commerce
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Consumer Product Safety
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Direct-to-Consumer Advertising
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United States
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United States Food and Drug Administration
9.Product safety analysis of somatic cell cloned bovine.
Song HUA ; Jie LAN ; Yongli SONG ; Chenglong LU ; Yong ZHANG
Chinese Journal of Biotechnology 2010;26(5):576-581
Somatic cell cloning (nuclear transfer) is a technique through which the nucleus (DNA) of a somatic cell is transferred into an enucleated oocyte for the generation of a new individual, genetically identical to the somatic cell donor. It could be applied for the enhancement of reproduction rate and the improvement of food products involving quality, yield and nutrition. In recent years, the United States, Japan and Europe as well as other countries announced that meat and milk products made from cloned cattle are safe for human consumption. Yet, cloned animals are faced with a wide range of health problems, with a high death rate and a high incidence of disease. The precise causal mechanisms for the low efficiency of cloning remain unclear. Is it safe that any products from cloned animals were allowed into the food supply? This review focuses on the security of meat, milk and products from cloned cattle based on the available data.
Animals
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Cattle
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Cloning, Organism
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Consumer Product Safety
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Dairy Products
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Female
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Meat Products
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Nuclear Transfer Techniques