浅谈“飞行检查”之前车之鉴

A brief talk on the lessons of “flight inspection”

本文以医用气体工程行业的特殊性为契机,介绍当前形势下的医疗器械行业的监管现状,并列举国家药品监督管理局历次医疗器械飞行检查的部分典型案例,供医疗器械生产厂家在符合《医疗器械生产质量管理规范》的过程中吸取经验教训,少走弯路。从管理者重视、查漏补缺、加强培训、加强内审四个方面入手,介绍符合规范应采取的措施方法。

Considering the particularity- of medical gas engineering industry-, this paper introduced the supervision and management situations of medical device industry-, and enumerated some typical cases of the previous medical device flight inspection by the China Drug Administration. In the process of complying with the ＂Quality- Management Standard of Medical Device Production＂, the manufacturers of medical devices can learn some experience and lessons. This paper suggested some measures that should be taken in accordance with the norms from four aspects： the attention of the managers, the inspection and complement of the missing, the enhancement of the training and the strengthening of the internal audit.