统一医疗器械技术审评尺度实践与探索

作者：Zhang Shiqing; Wang Yingjun^*

来源：Chinese Journal of Pharmacovigilance, 2021, 18(11): 1001-1003and1019.

DOI：10.19803/j.1672-8629.2021.11.01

• criterion
• evaluation
• medical device

Objective To outline the practice and exploration carried out by the Center for Medical Device Evaluation, NMPA(CMDE) in the unified evaluation criterion so as to provide a reference for relevant parties. Methods The existing problems in the system and the measures taken were analyzed, and the case of uniformity about medical device safety in CMDR was introduced. Results The CMDE further improved the quality management system, and carried out a number of useful explorations on the unified evaluation scale. Conclusion The unification of criterion is an important basis for ensuring the stability and repeatability of the evaluation, and the improvement of the system can effectively promote the unification of the evaluation criterion. ? 2021 Editorial Offfce of Chinese Journal of Pharmacovigilance.

• 单位
  华南理工大学