Either the establishment in China or the foreign establishment that wants to enter China medical device market under CFDA regulations may encounter some unexpected issues, as well as some other problems involved with medical device regulations. CIRS’s medical devices department is a particularly professional team and has affluent experience in various medical devices; we are performing as your local regulatory staffs and aiming to provide practical and individual solutions for your products. In addition, the case studies those are conducted by our team are offered for your concern, which have obtained the agreement of releasing from our customers in advance.
 
Our solutions

1. China Medical Device Regulatory Assistant Program (MDRAP)
2. China Authorized Representative
3. Case Studies