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find Keyword "乳房植入体" 2 results
  • IDEAS ABOUT REGISTRATION FOR BREAST IMPLANTS

    ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe 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. ConclusionThe 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.

    Release date:2016-08-31 05:39 Export PDF Favorites Scan
  • 乳房植入体产品的临床试验及上市后临床随访

    乳房植入体作为植入性整形医疗器械,其安全性和有效性直接影响着受术者的生活质量,是国家重点监管的医疗器械品种之一,注册申报时需提交规范的临床试验资料以支持其安全性和有效性。此类产品临床试验持续时间较长,需收集的数据内容较多,对于此类产品如何进行科学的临床试验设计,如何选择合理的临床评价标准,如何按照不同的产品适应证界定临床试验单元,如何对临床数据进行充分的分析,以及对于已上市的产品如何进行临床随访数据的收集,是企业和临床试验机构共同关注的问题。

    Release date:2016-09-08 09:18 Export PDF Favorites Scan
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