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Zhao P.,Center for Medical Device Evaluation
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery | Year: 2012

To review the registration and technical data for breast implants. Recent literature concerning registration for breast implants was reviewed and analyzed. The aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. The manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.


Zhang Z.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2012

Recent years, China medical devices industry has been a sunrise industry with widely-ranged products, high-tech innovation, and booming market demands. But with the globalization of market economy, China industry is still in the inferior position of competition. How to promote the industrial structure transition, increase scientific and technological level, speed up the updating of products, enhance the international competitiveness is one of the major tasks to maintain the healthy development of industry. This article makes a study on current situation of China medical devices industry, analyses the new opportunities, challenges and restriction factors, provides the countermeasures of strengthening industry competitiveness as well.


Zhang S.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2011

This article summarizes the progress and specifications of FDA regarding intravascular catheters, and hope this would be helpful to people concerned.


Xu X.,Guangzhou University | Tao A.,Guangzhou University | Xu Y.,Guangzhou University | Xu Y.,Center for Medical Device Evaluation
Nanoscale | Year: 2014

Hydrogels are a promising class of biomaterials that can be easily tailored to produce a native extracellular matrix that exhibits desirable mechanical and chemical properties. Here we report the construction of a hydrogel via the assembly of cucumber mosaic virus (CMV) capsid protein and Y-shaped and cross-shaped DNAs. This journal is © The Royal Society of Chemistry.


Zhao P.,Center for Medical Device Evaluation
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery | Year: 2012

To review the registration and technical data for sodium hyaluronate facial derma fillers. Recent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. The aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. The main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.


Zhang Y.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2013

Active implantable medical device develops rapidly in recent years. The clinical demands and current application are introduced, the technical trends are discussed, and the safety risks are analyzed in this paper.


Guo Z.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2012

This article introduces the clinical requests of indigenous diagnostic imaging ultrasound devices in first-time registration application and the clinical trial requests in Technical Review Guidance of Ultrasound Imaging Diagnostic Devices (category III) Registration and puts forward some questions of the guidance's implementation. It is hoped to help concerned people.


Lu Y.-F.,Center for Medical Device Evaluation
Yaoxue Xuebao | Year: 2013

Using brain microdialysis and LC-ECD, the content of dopamine in rat brain was detected to investigate the effects of ligustrazine. A liquid chromatography-electrochemical detector method has been established and validated for the determination of dopamine in rat brain dialysate. The results indicate that ligustrazine administration by subcutaneous injection significantly increased dopamine release in rat medial prefrontal cortex, nucleus accumbens and hippocampus in a dose-related manner. The drug's effects on dopa release in rat brain could be directly detected by microdialysis combined with HPLC-ECD and this method has the preponderance over traditional neurology methods.


Zhang Y.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2013

Deep brain stimulation (DBS) therapy develops rapidly in clinical application. The structures of deep brain stimulator and magnetic resonance imaging (MRI) equipment are introduced, the interactions are analyzed, and the two compatible problems of radio frequency (RF) heating and imaging artifact are summarized in this paper.


PubMed | Center for Drug Evaluation, National Institutes for Food and Drug Control and Center for Medical Device Evaluation
Type: Journal Article | Journal: Biologicals : journal of the International Association of Biological Standardization | Year: 2016

A sophisticated regulatory framework has been constructed for Human immunodeficiency virus (HIV) diagnostics in China, which have developed over the past 30 years. China National Institutes for Food and Drug Control acts as the legal institution in this regulatory framework, launching important activities to ensure the quality of HIV diagnostics. These include the analysis of the main problems faced in developing domestic HIV diagnostics, by investigating the quality of HIV diagnostics and their development; exploring the key factors affecting the quality of HIV diagnostics, to determine the criteria for screening national reference samples; the development of new technologies and methods for preparing reference samples; and the establishment of nine types of national reference panels and nine national standards to evaluate the quality of HIV diagnostics. Based on these researches, a quality evaluation system was established, including nine types of national reference panels, nine national standards for HIV diagnostics, and five sample banks (HIV-positive sample bank, HIV-negative sample bank, common international genotype sample bank, seroconversion series sample bank, HIV virus bank) to evaluate the quality of HIV diagnostics in China. The regulatory framework and the quality evaluation system are pivotal in ensuring the quality of the HIV diagnostics licensed in China.

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