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
;
Safety Management
3.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
9.Mandatory regulations and standards regarding cosmetic botanic ingredients in major countries and regions.
Nai-Tao SHEN ; Huan YUAN ; Qing-Bin LIN ; Lin TANG
China Journal of Chinese Materia Medica 2019;44(24):5488-5495
Cosmetics containing botanic ingredients have been used from thousands of years up to now in China. Because of the consumers' demand for health and beauty,the number of products about " botanic" have been growing rapidly in the cosmetics market,which has played an important role in upgrading the industry and enhancing the international competitiveness nowadays. Therefore,to strengthen the management about used botanic raw materials in cosmetics products and revise the application regulation of new raw materials has become an important work to ensure product quality,promote the healthy and stable development of cosmetic business. The article summarizes the related mandatory regulations and standards about botanic ingredients which used as activity function in major cosmetic business countries or regions. Furthermore,the information of botanic ingredients commonly used in non-special cosmetics notification and special cosmetic registration system were described to expect the better application and development.
China
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Consumer Product Safety
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Cosmetics/standards*
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Government Regulation
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Plant Preparations/standards*