Medical network - January 10, recently, the measures for the rapid examination of hunan province medical device registration (hereinafter referred to as "" method", ") officially released, this is hunan food drug administration in 2016 medical device registration management on the basis of full specification, further deepening the reform of the medical device review for examination and approval system and an important measure.
The "method", hunan food drug administration to seven kinds of situations of the second category of medical apparatus and instruments for product registration, implement rapid examination: one is the state food and drug supervision and administration bureau or the innovation of the hunan province food and drug administration determined medical apparatus and instruments; 2 it is listed in the state or in hunan province science and technology major projects, key research and development program of medical apparatus and instruments; Third, diagnosis or treatment of rare diseases, malignant tumor, and has significant clinical advantage of medical apparatus and instruments; Four is unique diagnosis or treatment of the elderly and multiple diseases, and there is no effective diagnosis or treatment of medical apparatus and instruments; Five is dedicated to children, and has significant clinical advantage of medical apparatus and instruments; Six is urgent clinical needs and their varieties in our country, there is no registration of medical apparatus and instruments; Seven other should be quick to the approval of medical devices. To listed in the rapid examination of medical device product registration, sorted by receiving time alone, priority for technical review and administrative examination and approval and registration quality system verification, its time to all the rules and regulations on the basis of the cut in half.
The "method" regulation, medical apparatus and instruments for innovation, the provincial food and drug supervision and administration departments at all levels and the provincial medical equipment technical evaluation, inspection institution shall assign a early intervention, counseling. Medical device testing institutions shall be conducted after receiving sample priority registration, inspection, and issue inspection report. Hunan food drug administration registration management department and the medical instrument technical evaluation institutions may, according to enterprise application, of innovative medical devices clinical evaluation scheme with leading consulting services. Hunan food drug administration can coordinate medical instrument clinical trial institution, priority to conduct clinical trials. To carry out the innovative medical device clinical trials, shall abide by the medical equipment quality control standard for clinical trials.
To improve the administrative efficiency, easing the burden on enterprises, the "method" also for enterprises to avoid the product registration and submit the same application for many times, and avoid the repetition of the enterprise to carry out spot checks made specific provision.
Food in hunan province food and drug administration issued the "method", is designed to encourage technology innovation and transformation of scientific and technological achievements of medical apparatus and instruments, improve the efficiency of medical apparatus and instruments for examination and approval of the review, promote the province's medical equipment industry development. In the formulation process, the methods, hunan food drug administration widely solicit opinions of the enterprises, industry associations and related units, and reported to the provincial government legislative affairs office for the record. |
