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
5.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
;
United States Food and Drug Administration
10.Research progress of Chinese herbal medicine raw materials in cosmetics.
Yan-jun XIE ; Wei-jun KONG ; Mei-hua YANG ; Shi-hai YANG
China Journal of Chinese Materia Medica 2015;40(20):3925-3931
Advocating green, nature, environmental protection, safety and the pursuit of efficacy are the trends of cosmetics in the world. In recent years, more and more Chinese herbal extracts with mild, high safety and small irritation are applied to cosmetics as the natural additives. This has become a new hot spot. The recent application advances of Chinese medicine raw materials in cosmetics are overviewed according to their main functions. This review will provide useful references for the future development and application of Chinese medicinal herbs cosmetics.
Animals
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Biomedical Research
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trends
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Consumer Product Safety
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Cosmetics
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analysis
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Drugs, Chinese Herbal
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analysis
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Humans