With the fast development of the modern medical sciences and technologies now,the complicated precision medical equipment can hardly operate without the medical device software.The medical software provides the evidences for diagnosis and treatment,or directly controls the medical equipment during the treatment. Application of computer software in the medical equipment comes closer to human being than anything else,and shall directly concern with the health and even the life of human beings.The study intends to analyze the legal basis and regulatory issues of medical software,introduce the experience of US,EU and Germany,and propose the preliminary suggestions for improvement. <<