Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (5): 292-296.

• Orginal Article • Previous Articles     Next Articles

Comparative Study of Natural Rubber Latex Condom Labeling Regulation in USA and China

YANG Xiao-dong   

  1. Center For Medical Device Evaluation, SFDA, Beijing 100045, China
  • Received:2012-03-20 Online:2012-05-10 Published:2015-08-10

Abstract: Objective Provide references for the standardized management of labeling for natural rubber latex condom in China. MethodsBy content analysis, compare U.S. FDA regulations on labeling for natural rubber latex condom with China SFDA's. ResultsU.S. FDA regulatory system for natural rubber latex condom labeling is complete, which can effectively control the risk of natural rubber latex condom, being operational, it is worth for the relevant regulatory authorities in China to learn from. ConclusionChina can improve the natural rubber latex condom labeling regulations construction and management from the following areas: to amend the medical equipment manuals, labels and packaging and labeling regulations, as soon as possible, it is necessary to formulate the terms of natural rubber latex condoms; to establish guidance document of labeling for natural rubber latex condom; to create the database platform of labeling for natural rubber latex condom to query.

Key words: natural rubber latex condom, labeling, comparative study