It is hereby announced that in order to implement the Regulation on the Supervision and Administration of Medical Devices (Order of the State Council P.R.C., No. 650) and Measures for the Administration of Medical Device Registration (Order of CFDA, No. 4), intensify the medical device registration management supervision and guidance, clarify the technical requirement to the registration and reporting of passive implantable medical devices, and guide the applicants in preparing the registration and reporting materials on shelf life of passive implantable medical devices, CFDA prepared and issued the Guideline on Registration and Reporting Materials about Shelf Life of Passive Implantable Medical Devices (2017 revised edition) (see attachment).
Attachment: Guideline on Registration and Reporting Materials about Shelf Life of Passive Implantable Medical Devices (2017 revised edition)
China Food and Drug Administration
May 12, 2017