PREVIOUS ARTICLE PRE-RECORDED ...
China CFDA adds additional paperwork burden for medical device submissions Next

China CFDA adds additional paperwork burden for medical device submissions

By Tim Lin

Time To Read Less than a minute

For Class II and Class III new registrations of imported medical devices (including IVD), and Class III new registrations of domestic-manufactured medical devices (including IVD), China CFDA now requires submissions to also include both an identical paper-based copy (photocopy) of the original registration dossier, and an electronic version in the submission package along with the original. The identical paper-based copy should be labeled so it is clearly differentiated from the original copy. The electronic version should be in PDF format and stored in an USB drive. The submission must also include a declaration that the submission document, copy and electronic file are identical.