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医疗器械工业是一个高技术、多学科、知识密集型的产业。医疗器械产品是一种以非化学反应,不参与人体生理代谢而达到对人体疾病的诊断、治疗、预防,调节人体生理功能或者替代人体器官的仪器、设备、装置、植入物、材料等产品。因此,医疗器械作为一种防病治病、康复保健的特殊产品,国家应有一套完备严密的法规体系加以制约。所以,医疗器械的立法工作应是行业管理中的一件大事。下面,笔者对此谈一些个人的肤浅认识,供大家参考。
The medical device industry is a high-tech, multi-disciplinary, knowledge-intensive industry. Medical device products are devices, devices, devices, implants, materials and other products that are non-chemical reactions that do not participate in the physiological metabolism of the human body to achieve the diagnosis, treatment, and prevention of human diseases, and regulate physiological functions or replace human organs. . Therefore, medical devices as a special product for disease prevention and treatment, rehabilitation and health care, the state should have a set of complete and strict regulatory system to restrict. Therefore, the legislative work of medical devices should be a major event in the management of the industry. Below, the author talks about some personal superficial understandings for your reference.