I V D   P R O D U C T  R E G I S T R A T I O N

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.