The Study On The Present Situation Of The Registration Regulation And The Review System Construction Of The Medical Device

Objective:To study the present situation of the construction of China’s medical device registration supervision system and approval system, analysis of shortcomings of the field of existence, put forward the countermeasure of building in the new period of China medical device registration of construction management, review and approval system, to promote the medical device registration management standardization, modernization of means, scientific review approval.Methods:Based on the literature collection, research, teaching practice and literature data analysis, to summed up the main problems of the current our country registered medical device supervision and review of the examination,to analysis the factors which restrict the development of the medical equipment business, and to reference the advanced experience of foreign regulation of medical device registration, aimed at put forward the countermeasures to solve the problem in the development.Results:Based on a lot of research, teaching practice and on the literature data analysis, induction and explored the factors which restrict the development of the medical equipment business, mainly displays in:industry lags behind the development of the rule of law construction needs; Medical apparatus and instruments for examination and approval of the review mechanism, evaluation standard is different; Information platform construction lag, the impact of regulatory quality and work efficiency; Registration regulation lack of specialized personnel, team overall quality improvement; Medical equipment product innovation is insufficient, registered supervision area lack of depth research.Conclusion:Because medical devices known as "drug", it directly or indirectly ACTS on the human body, its quality is related to public health safety, and social harmony and stability, and registered supervision is the key link in medical equipment management, to make the enterprise can healthy, sustainable development, must be a breakthrough in the following aspects:accelerate the construction of the rule of law, raise the legal effect, to ensure the strong implementation of the regulation; Review innovative medical device registration regulation mechanism, the establishment of the national regional review center, is advantageous to the licensing and regulation, the review standard unified, to ensure the safety of medical equipment, effective; We will deepen reform of the medical instrument technical review mechanism and improve the supervisory ability of the industry as a whole coordination; Strengthen the regulation of registration with the review of the talent team construction, innovative talent training mode, improve the efficiency of supervision, review and level, to meet the needs of the medical device development in the new period; To speed up the construction of medical device registration regulation and review information platform, promote the scientific and standardization of medical device registration regulation means and modernization.