Risk Analysis and Countermeasures Investigating Based on Medical Device Registration Review Process / 中国医疗器械杂志

In order to strengthen the supervision and management of medical devices, China implements pre-market registration and approval system for medical device. Technical evaluation is a key point of Chinese medical device registration management system. This study, by process-oriented, systematically sorts out the risks existing in each part of the review process. The countermeasures for risk prevention are proposed, hoping to strengthen the quality control of the whole process of review, improve the quality and efficiency of the review effectively, and ensure the various reform measures of the medical device review and approval system effectively.

Discussion on Administrative Innovation of Medical Device in China and U.S / 中国医疗器械杂志

This article refreshes the innovative review approach of medical device in China at first. It proposes reference through presenting a series of existing review and approval of innovative medical device in U.S. as well as new tools and methods for supporting scientific review.