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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 corrections and clarifications to the translation.
The requirements are modeled on FDA’s Submission guidance and 62304 but with some significant differences, including using 62304 safety classes which are not always consistent with FDA’s levels of concern and not requiring design specifications. Although not stated in the document, we have heard from a number of sources that the SFDA has been expecting version numbers in the field to match the version number in the cleared application – unlike the FDA, which does not require new submissions for all changes.