结合产品—医疗器械的一种新形式

Combination Products: A New Model of Medical Devices

结合产品是一种由药物与医疗器械：生物制品与医疗器械：药物与生物制品：药物、医疗器械和生物制品结合在一起的一种医疗产品新形式,它对制药业和医疗器械业产生新机遇,同时对管理形成新挑战,已经成为医疗器械和药品研发的新热点。叙述了结合产品的特性以及它对医疗器械和制药产业发展的意义。

A combination product is a new model of the medical product that incorporates at least two of the regulated component categories of device, drug, or biological product into one product. It has become a new hot point within the development of devices and drugs, and has brought about a new opportunity for device and drug industries and a new challenge for administration too. In the paper, the properties of combination products are summed up and the impact on device and drug industries are discussed.