The Research Of Regulation And Methodology For Clinical Evaluation Of Medical Device

Research Purposes: The article mainly discusses that as the development of our medical device industry, the weakness of its system of administration had appeared, specially, the clinical evaluation of medical device has so many problems to solve. that this article makes suggestion and strategy for the regulation and methodology of clinical evaluation for medical device in China.Research Content:First of all, I make an introduction of the concept of clinical evaluation for medical device, as well as its position and role in the regulation of medical device.Secondly, as clinical evaluation is one part of the entire regulation system, I begin with the status analysis of medical device regulation in China,, for the purpose of making suggestion.Thirdly, I explain the status of the regulation and methodology of clinical evaluation for medical device in USA and Europe objectively, for the purpose to get inspiration.Fourthly, I combine the status of clinical evaluation for medical device in China with the experience from USA and Europe, and make suggestion from the perspective of regulation as well as the methodology.Research Methods: Comparative Analysis,Induction and Deduction,Delphi MethodResearch Conclusion: The purpose of the regulation and methodology for medical device is to verify the safety and effectiveness of medical device. It should be scientific, transparent, can impulse the development of productivity, stable, successive, at the right moment and keep up with the other countries in the world. We should control the scope of clinical investigation, speed up the GCP, increase the functional authority of management, and elevate the cognition and level for clinical evaluation of related people. The research of methodology of clinical evaluation of medical device should also be pay attention.