上海同城对对碰

Anhui Provincial 上海水磨会所网 Food and Drug Administration issued a second type of medical device priority approval method

In order to encourage research and development innovation, ensure the clinical use of medical equipment, to promote high-quality development of medical equipment industry, recently, the Anhui Provincial Food and Drug Administration issued the "Priority Approval of the Second Category of Medical Devices in Anhui Province". The "Measures" stipulate that the working principle or mechanism is a fundamental improvement in the first in Anhui Province, product performance or safety and similar products, and technically in the domestic leading level, which has significant clinical application value, and product basic shaped medical Instruments; medical devices included in national, provincial science and technology, major or key R & D plans; clinical needs and medical devices registered in Anhui Province without variety products; diagnosis or treatment of rare diseases, malignant tumors and have obvious clinical advantages, Diagnosis or treatment of unique and multi-disease, there is no effective diagnosis or treatment, dedicated to children and have obvious clinical advantages; can achieve key technologies, core parts breakthrough, complete domestic alternative medical equipment; provincial bureau Other other types of products such as medical equipment that can be applied to priority approval can be prioritized.

The "Measures" clearly, the medical device included in the priority approval, the Provincial Food and Drug Administration’s license registration office should establish a green channel, priority, priority approval, administrative examination and approval, and reduce the reduction of the statutory time limit 65% or more.

The Provincial Food Pharmaceutical Test Research Institute’s related products that can be tested in this Court shall prioritize inspection, strengthen technical services and guidance. The test time limit 上海浦东品茶网 is reduced to 63 working days, which is more than 30% compared to the regulations; the hospital cannot be tested, Guided the applicant to entrust a qualified medical device inspection agency to inspect; applicant self-test, should standardize the applicant’s self-test behavior, and counseling the applicant’s orderly self-test work.

The provincial drug review inspection center should be intervened in advance, the special person is responsible, the research is jointly, and the whole process will provide pre-consulting services to the clinical trial program, prioritize the verification and technical review of medical equipment registration quality management system, and the review time limit is 47 A working day, which is more than 20% compared to the legal time limit, and the system verification and technical review is 闵行kbzj made in series and further enhances the efficiency of the review work. The "Measures" stipulate that instruments that meet national innovation and priority approval in the preferred approval, such as the main working principle or mechanism of action, and the first medical device, and the medical equipment included in national science and technology or national key research and development plan. Experts, the whole process is a good policy, technology and other service guarantees, registration time limit further reduction, inspection, administrative examination and approval and review time limit is reduced to 54 working days, 7 working days and 42 working days, which are reduced than the statutory time limit 40%, 70% and 30% respectively.

(Editor: Guanfei, Zhang Lei) Sharing let more people see.