Abstract: To provide reference for further improve the level of medical devices clinical trial, to ensure the medical devices quality combing with the problems found in the medical devices clinical trial in Shandong province, the problems and countermeasures of medical devices (Ⅱ) clinical trial were explored. Four countermeasures were put forward to solve the problems of medical devices (Ⅱ) clinical trial from different angles including sponsors, clinical trials institutions and the important part of clinical trials:raising the threshold of entry, consummating relevant laws and regulations, establishing quality management system, strengthening personnel training, attaching great importance to CRA and CRC.