Study On Medical Device Recall Law System In China

With the development of our country's market economy and the accelerated globlization process,our native medical device has even got the rapid development. Although, medical device has playing an important role in preventing disease, treating disease, protecting health, promoting disease rehabitation and so on., the Medical Device Adverse still happened. Because we are short of the regulations of medical device recall, so the medical device recall's work is difficult to execute.In our country, defective product has attracted more attention, Chinese government has published serval laws of the recall, such as Administrative Regulation on Recalls of Defective Automobile Products, Administrative Regulation on Recalls of Defective Food Products, Administrative Regulation on Recalls of Defective Children Toy Products and Administrative Regulation on Recalls of Defective Drug. Those recall law system also begin to improve slowly. On Mar 18th, 2008, State Food and Drug Administration issued the (consultative) paper of Administrative Regulation On Recalls of Defective Medical Device Products. On September 7th, 2010, the Regulation for the Administration of Affairs concerning Medical Device (Amendment) has to solicit opinion from the general public, it indicated our native medical device recall law system would be set on. Constructing the law system of defective medical device recall, not only can advance the development of enterprise, but also can protect consumer's health and safety efficiently. At present, the study of the medical device recall law system is still not enough, so it is necessary for us to study on medical device recall law system in China.There are four parts in this text except the introduction and the conclusion. The text is about 20,000 words.The first part is about the essential information of medical device recall law system. In this part, firstly, the writer introduces the legislation advancement of medical device law. Secondly, the writer introduces what is the defective medical device. Thirdly,the paper analyzes the legal relation of medical device recall. Finally, the writer points out the importance significance of medical device recall law system.The second part is the theory about law system of defective medical device recall. This part is mainly theoretical analysis, it includes two main parts: the law territory attribute of medical device recall law system and the law value theory of medical device recall law system .The third is studying and learing the medical device recall law system about the developed countries. In this part, first, the writer introduces the medical device recall law system of America, Japan and Australia respectively. Then, the writer introduces the significance of the medical device recall law system of America, Japan and Australia to our native medical device recall law system.The fourth is how to construct the law system of defective medical device recall in China. This part analyzes the law system of our native medical device recall and the institution of our native medical device recall law system.