China SFDA Draft Software Premarket Requirements$

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions.

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 . . .

Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.