The current situation and development of medical device testing institutes in China. (3rd April 2017)

• Record Type: Journal Article
• Authors: Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu
• Is Part Of: Expert review of medical devices. Volume 14:Number 4(2017)
• Page Start: 263
• Page End: 269
• Publication Date: 2017-04-03
• Subjects: Medical device -- standardization -- testing institutes -- premarket registration -- surveillance -- CFDA; Medical instruments and apparatus -- Periodicals; 610.28
• DOI: 10.1080/17434440.2017.1299572
• Languages: English
• ISSNs: 1743-4440

Abstract

ABSTRACT: Introduction: This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions – testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels. These testing institutes also play an important role in technical support during medical device premarket registration and post market surveillance, they are also the vital practitioners of Chinese medical device standardization. Expert Commentary: Chinese medical device testing institutes are technical departments established by government, and serve the regulatory functions of government agency. In recent years, with the rapid development of medical device industry as well as constantly increasing international and domestic medical device market, the importance of medical device testing institute is more prominent, However, there are still some problems unsolved, such as their overall capacity remains to be improved, construction of standardization is to be strengthened, etc.