title: The current situation and development of medical device testing institutes in China.
abstract: 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.
authors.affiliation: a School of Biological Science and Medical Engineering , BeiHang University , Beijing , China.
authors.forename: Xiaofang
authors.initials: X
authors.lastname: Yang
authors.affiliation: b Center of Medical Devices , National Institutes for Food and Drug Control , Beijing , China.
authors.forename: Ruihong
authors.initials: R
authors.lastname: Mu
authors.affiliation: a School of Biological Science and Medical Engineering , BeiHang University , Beijing , China.
authors.forename: Yubo
authors.initials: Y
authors.lastname: Fan
authors.affiliation: b Center of Medical Devices , National Institutes for Food and Drug Control , Beijing , China.
authors.forename: Chunren
authors.initials: C
authors.lastname: Wang
authors.affiliation: a School of Biological Science and Medical Engineering , BeiHang University , Beijing , China.
authors.forename: Deyu
authors.initials: D
authors.lastname: Li
mesh_terms: D000047:Academies and Institutes; D002681:China; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D012015:Reference Standards
keywords: CFDA; Medical device; premarket registration; standardization; surveillance; testing institutes