中国医疗器械出口应对欧盟壁垒的策略

目的欧盟国家公布于2005年8月起实施的WEEE指令，与2006年起实施的RoHS指令构成了医疗器械出口欧盟的环保双指令；而另一方面，它们与之前欧共体时期设定的CE认证以及欧盟医疗器械三指令又共同构成了中国医疗器械出口欧盟时的坚实壁垒。数据显示，WEEEE指令实施后的几个月内我国医疗器械产品出口欧盟的增幅与去年同期相比有所下降。因此，有必要探寻应对此类壁垒的具体策略．方法通过对各个壁垒属性分析以及带来的负面影响来探讨如何应对出口壁垒以及出口门槛日渐提高的形势。结果与结论我国医疗器械除在注重成本领先战略实施的同时，还需进一步加强和完善上市后安全监测系统和售后服务体系，同时应积极培养更有效的信息快速沟通机制．

Strategies for the Chinese Medical Equipment export confront with the European Trade Barriers

Objective The WEEE Command launched after the April of 2005, and the Rolls Command launched after 2006 has become Double Environmental Command when exporting Medical Equipment to European countries. Meanwhile, with the CE Certification and those three Commands of European Medical Equipment formulated in the period of former EU, the solid trade barriers thus have been shaped. According to some relative statistics, the increasing rate of exportation of the Chinese Medical Equipment to European countries has witnessed some recession compared with that of the same period of last year after the official operation of WEEE Command. It is necessary to seek the concrete methods to meet the challenges those barriers brought. Methods Discuss and seek how to confront with the trade barriers and the heightened exporting threshold through the analysis of varieties of barriers as well as the negative influence they posed. Result and Gonclusion On one hand, those Medical Equipment Enterprises should focus on the cost-effective strategy,; on the other hand, the security monitoring system and the after-sale system should be further optimized, as well as the cultivation of a more effective information exchanging mechanism.