W H A T W E C A N O F F E R QH Medical offers full services for the IVD product registration, including clinical trials. -- Determine product classification; -- Investigate and evaluate the best route to NMPA (CFDA) approval in China; -- Development of product registration standards for the NMPA (CFDA) testing; -- Follow up NMPA (CFDA) testing procedures; -- Develop clinical protocols, evaluate the hospitals and coordinate clinical trials, if needed; -- Translate documents and labeling; -- Prepare final submissions and act as Agent in China (Legal and After Sales), if needed; -- Follow up with the NMPA (CFDA) after submission; -- Caretaker for all the registration information and documentation. |