Research on Supervision System of Combination Product in FDA / 中国医疗器械杂志

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 / 中国医疗器械杂志

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 / 中国医疗器械杂志

<p><b>OBJECTIVE</b>To investigate the feasibility of using liquid chromatography (HPLC) to characterize the 3, 4-Dihydroxyphenylalanine (DOPA) redox state of mussel adhesive protein (MAP).</p><p><b>METHODS</b>The DOPA and protein contents of MAP were determined by HPLC, Arnow and Bradford methods respectively.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSIONS</b>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.</p>

The current situation and suggestions on the institutes for medical devices test in China / 中国医疗器械杂志

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 / 中国医疗器械杂志

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 / 中国医疗器械杂志

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.