This paper introduces the current status of Chinese medical device testing and inspection institutes. There are 53 such institutions, including 10 national institutions. Medical device testing and inspection institutions service in government regulation and supervision of medical devices, playing a technique support role for medical devices from registration before appear on market to monitor and supervision after listing. Meanwhile, they are important practitioners of medical devices standardization work. Finally, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment.
China ; Equipment and Supplies ; standards ; Health Systems Agencies ; Reference Standards

By analysis on existing problems of the classification, the suggestions were put forward to provide a reference for improving the classification of medical devices.
Equipment and Supplies ; classification

The regulatory history and status of in vitro diagnostic reagents (IVD) at home and abroad are introduced. Suggestions are also provided on the administration of IVD.
Diagnostic Techniques and Procedures ; instrumentation ; Health Services Administration ; Indicators and Reagents ; standards ; Product Surveillance, Postmarketing

On the basis of introducing FDA's regulatory measure and relevant requirement for life-cycle management of combination product, this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product's current situation, in order to promote innovative development of relevant industries.
Device Approval ; Drug Approval ; United States ; United States Food and Drug Administration

This paper introduces the current status of Chinese medical device testing and inspection institutes.There are 53 such institutions, including 10 national institutions. Medical device testing and inspection institutions service in government regulation and supervision of medical devices, playing a technique support role for medical devices from registration before appear on market to monitor and supervision after listing. Meanwhile, they are important practitioners of medical devices standardization work. Final y, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment.

Objective The present study was designed to analysis some misunderstanding on "medical devices classification rules" of CFDA, in order to correct understand and use the regulation. Methods The contents of "medical devices classification rules" by CFDA have been analysis and generalized. Results Through analyzing, we can conclude as followed: the priority principle of classification catalogue; the comprehensive judgment principle based on the classification decision table and special classification principles; medical devices' management class could be changed by CFDA according to risk analysis results. Conclusion It is helpful to reach an agreement on the classification of a medical device among the regulatory authorities, production enterprises and other aspects, and establish a solid foundation for CFDA's regulatory science.

Based on analyzing the classification catalog of medical device for rehabilitation, combined with the example,this paper discusses the principle of judgment of the classification of medical device for rehabilitation, and the naming and technical standards related to classification, puts forward the suggestions of classification management,attributes definition, and the naming, in order to provide support for promoting the reform of medical device classification management, and improving the level of scientific supervision.

By analysis on existing problems of the classification, the suggestions were put forward to provide a reference for improving the classification of medical devices.

The new version of Medical Device Classification Directory(revised Draft has opened to the public comments. This paper briefly introduces the classification of medical device in China and the historical development of the directory, and focuses on the analysis of the main changes in the new version of the directory to help the supervision department, manufactures, and related organizations better understand and use the new directory.

A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.
China ; Equipment Safety ; Equipment and Supplies ; United States ; United States Food and Drug Administration