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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. Source


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. Source


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. Source


Nie F.L.,Peking University | Nie F.L.,Center for Medical Device Evaluation | Zheng Y.F.,Peking University | Wei S.C.,Peking University | And 5 more authors.
Journal of Biomedical Materials Research - Part A | Year: 2013

Bulk nanocrystalline Ti bars (Grade 4, φ4 × 3000 mm3) were massively fabricated by equal channel angular pressing (ECAP) via follow-up conform scheme with the microcrystalline CP Ti as raw material. Homogeneous nanostructured crystals with the average grain size of 250 nm were identified for the ECAPed Ti, with extremely high tensile/fatigue strength (around 1240/620 MPa) and adorable elongation (more than 5%). Pronounced formation of bonelike apatite for the nanocrystalline Ti group after 14 days static immersion in simulated body fluids (SBF) reveals the prospective in vitro bioactive capability of fast calcification, whereas an estimated 17% increment in protein adsorption represents good bioaffinity of nanocrystalline Ti. The documentation onto the whole life circle of osteoblast cell lines (MG63) revealed the strong interactions and superior cellular functionalization when they are co-incubated with bulk nanocrystalline Ti sample. Moreover, thread-structured specimens were designed and implanted into the tibia of Beagles dogs till 12 weeks to study the in vivo responses between bone and metallic implant made of bulk nanocrystalline Ti, with the microcrystalline Ti as control. For the implanted nanostructured Ti group, neoformed bone around the implants underwent the whole-stage transformation proceeding from originally osteons or immature woven bone to mature lamellar bone (skeletonic trabecular), even with the remodeling being finished till 12 weeks. The phenomenal osseointegration of direct implant-bone contact can be revealed from the group of the ECAPed Ti without fibrous tissue encapsulation in the gap between the implant and autogenous bone. © 2012 Wiley Periodicals, Inc. Source


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. Source

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