Role of Standards in Medical Device Evaluation

doi:10.19803/j.1672-8629.2021.01.01

Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (1): 1-3.
DOI: 10.19803/j.1672-8629.2021.01.01

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Role of Standards in Medical Device Evaluation

ZHANG Shiqing¹, ZHANG Xingdong^2,*

¹Center for Medical Device Evaluation of NMPA,Beijing 100081,China;
²National Engineering Research Center for Biomaterials,Sichuan University,Chengdu Sichuan 610064,China

Received:2020-08-27 Revised:2021-01-18 Online:2021-01-15 Published:2021-01-18

Abstract

Abstract: Medical device standards are important reference for evaluation of medical devices.However,there has been little study on the role of standards in medical device evaluation or on ways to give full play to the technical support of standards.This article was intended to discuss the role of standards in medical device evaluation based on the work experience of the author and offer recommendations for personnel concerned.

Key words: medical device, evaluation, standards, safe and effective

CLC Number:

R969

ZHANG Shiqing, ZHANG Xingdong. Role of Standards in Medical Device Evaluation[J]. Chinese Journal of Pharmacovigilance, 2021, 18(1): 1-3.

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Role of Standards in Medical Device Evaluation

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