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- Clinical Trials for Medical Devicess”, only the devices designated by CFDA to be exempted from clinical trial...2017-10-02 17:15:36
- Quality management and Compliance for medical devi...g until Jan. 1st 2018 according to CFDA notice No.15-2014. The more inform...2017-10-02 17:02:41
- 有源医疗器械答疑解惑汇总证据证明差异对安全有效不造成影响即可。 6.问:临床评价时,是否必须跟CFDA批准的产品技术要求逐项比对?答:比对对产品特性重要的性能指标。 7.问...2017-08-28 10:38:01