Chinese FDA Builds on Medical Device Submission Document Requirements

The China Food and Drug Administration (CFDA), has put out new requirements for registrants to submit in order to initiate premarket reviews of their products.

Chinese market applicants with Class II and III devices will have to submit, in addition to their original registration files, photocopies and soft copies of the files in PDF format; including a declaration of consistency attesting that all three submission formats contain the same information.

The new CFDA submission requirements go into effect November 1, 2016. — Cynthia Jessup