对我国药械组合产品管理的思考

Discussion on drug/medical device combination products' management

我国主管当局于2009年明确了药械组合产品的相关管理,但与国外相对成熟的管理体制比较,尚需完善,也面临着更多的挑战。本文简介了国外相关管理现状,并结合工作实际,对我国关于药械组合产品的管理体制提出了建议。

China Food and Drug Administration（CFDA） issued regulations on drug/medical device combination products in 2009.However,comparing with the foreign mature management system,we have to improve our system and face the challenge. This article introduces the present situation of foreign management and provides suggestions connecting with the practice for improvement of CFDA＇ management on drug/medical device combination products.