The Second Category Of Medical Equipment Manufacturing Enterprises In Anhui Province Existing Problems And Countermeasures In The Product Registration

In recent years, with the high-speed development of society, the progress of science and technology innovation, the increasing health care needs of the broad masses,, the development of the medical device industry both in the public health security and in the development of the national economy occupies more and more important position.In accordance with the relevant provisions, within the territory of the People’s Republic of China, the units and individuals who are engaged in medical equipment development, production, management, use of activities and supervision and management must comply with the regulations on the supervision and administration of medical devices. According to the regulations, the second category of medical apparatus and instruments must be approved by the registered before production, and marketing.Products are safe and effective from the design. the design phase is destined to the efficacy and safety of the product. This article starting from the registration of medical device products, discuss the existing problems and countermeasures in the medical devices industry from the origin of medical equipment products. Food and drug evaluation and certification center of Anhui province takes on technical review of the second category of medical device product. In this paper, the original data of large number of Anhui medical equipment product registration information were statistically analyzed by using samples. This article use descriptive statistics analysis method of concentration determination method, teasing out the second category of medical devices in Anhui province on the problems existing in the product registration, and classifying them one by one to make a concrete analysis of these issues in detail.At the same time, through the interview survey of the Anhui provincial supervision department, technical institutions and staff related to medical device of manufacturing enterprise, We understand in depths the current situation of the second category of medical equipment product registration work in Anhui province, including the existing problems, the reasons, and a detailed analysis. Finally we attempt to put forward further targeted countermeasures and suggestions for the improvement of the status quo.For domestic and foreign relevant literatures focusing on product registration of medical device are very little.the author tries to write this article in order,to guide the enterprise to improve the efficiency of the product registration, simutaneously hope that through the joint efforts of the society from all walks of life, we can make registration work of medical equipment product of our province more perfect, more responsive to the future demand for the development of the medical device industry.