China SFDA Draft Software Premarket Requirements$

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The SFDA prepared a draft document entitled "Explanations on the Basic Requirements of Application for Registration of Medical Device Software" on April 28, 2012, which is linked below. This was initially translated to English by JIRA (Japan Industries Association of Radiological Systems), and Shawn Yang of SoftwareCPR (a native Chinese speaker and US medical device software expert) reviewed the original Chinese and made some . . .

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