Abstract: RPS is a message standard that can be used for the electronic submission of product information between a company and a regulatory agency for the purpose of gaining market authorization. Based on the lately progress of RPS, this article introduces the background, contents and purpose of RPS, and the positive promoting effect was discussed for the development of future medical device, evaluation and administration from medical device industry, international trade integration, reforming current evaluation and approval system, and constructing informationized administration in China.

Key words: medical device, RPS, IMDRF, evaluation and approval