Orthopedic product registration in China Food and Drug  Administration (CFDA)

Starting from June 1, 2014, the CFDA has  simplified the requirements for the anodized orthopedic product registration.  Now, CFDA no longer require bio-compatibility tests per anodizing on the  product.  You only need to submit the two test reports: 1) cytotoxicity tests, and 2)  scanning electron microscopy (SEM).   You  can check directly with Tianjin Medical Device Quality Supervision and Inspection Center (CFDA designated agent):  

We can help your product  registration in CFDA  (fee-based  services)