[Research on Supervision System of Combination Product in FDA].

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.

[Analysis on Re-classifcation Management Procedure of Medical Devices in the United States].

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.

[Study on the 3,4-Dihydroxyphenylalanine Redox State Characterization Method of Mussel Adhesive Protein].

OBJECTIVE: To investigate the feasibility of using liquid chromatography (HPLC) to characterize the 3, 4-Dihydroxyphenylalanine (DOPA) redox state of mussel adhesive protein (MAP). METHODS: The DOPA and protein contents of MAP were determined by HPLC, Arnow and Bradford methods respectively. RESULTS: With extended oxidation time, the protein contents of MAP samples remained unchanged whereas the DOPA contents declined. The retention times of main peaks in HPLC for both the accelerated oxidation and retained samples shifted as the storage time extended, which could be related to the changes of sample redox state. CONCLUSIONS: The redox state of MAP can be characterized by the change of HPLC peak retention time. HPLC can be used in the research on the MAP redox state, which is beneficial to the product development and quality control.

[Analysis of Common Problems in Classifcation of Medical Devices].

OBJECTIVES: 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. CONCLUSIONS: 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.

[Design and Consideration on the Revision of China Medical Device Classifcation Directory].

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.

[Analysis and Prospect of Classifcation Management of Medical Device for Rehabilitation].

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.

[Study on the Classification and Regulation of Medical Devices in Europe and America in IVD and the Enlightenment to Our Country].

In vitro diagnostic product(IVD) involved in disease prevention, diagnosis, treatment options, efficacy evaluation, etc., the quality level directly affects the accuracy of diagnosis. Based on the correct identification of the risk of IVD, a reasonable classifications of great significance to achieve scientific regulation, conservation of regulatory resources, promote the healthy development of the in vitro diagnostics industry. In this paper, opinions and suggestions on the reform and perfecting the regulatory classification of IVD in China is put forward through the analysis of the classification management system of IVD in Europe and the United States, combined with the status quo of China;s regulatory classification and existing problems.

[Present Situation and Thinking on the Reform of the Classifi cation and Regulation of Medical Devices in China].

This paper introduces the domestic device regulatory classifi cation. Risk factors of medical equipment are analyzed. Combined with the analysis of the present situation of medical device regulatory classifi cation in china, this paper puts forward advice to reform and improve China's medical device regulatory classifi cation system.

[The current situation and suggestions on the institutes for medical devices test in China].

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.

[The several problems to be paid attention to the classification of medical devices].

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

[Study on the supervision of in-vitro diagnostic reagents].

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.

The current situation and development of medical device testing institutes in China.

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.