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近年来,随着科学技术的迅速发展,生物医学材料和制品的临床应用日益增多,在防病治病中发挥了重要的作用。生物医学材料和制品由医生直接用于人体,它与药品一样,具有不同于一般工农业产品的特殊性,其安全有效性及质量的好坏直接关系到医疗效果和病人的生命安危。很多国家立法由卫生部门对其进行质量监督管理,实行上市前批准制度。我国生物医学材料和制品的研制较国外起步晚,但发展较快。由于长时间存在着的产品无统一审批,监督管理不完善的原
In recent years, with the rapid development of science and technology, the clinical application of biomedical materials and products has been increasing, playing an important role in disease prevention and treatment. Biomedical materials and products are directly used by doctors for human body. Like medicines, they have particularities that are different from general industrial and agricultural products. Their safety, effectiveness and quality are directly related to medical effects and the lives of patients. Many national legislations are subject to quality supervision and management by the health department and a pre-marketing approval system. The development of biomedical materials and products in China started later than in foreign countries, but developed rapidly. Because there is no unified approval for the long-term existence of products, the supervision and management are not perfect.