应用纳米材料类医疗器械产品的风险防控

Risk Prevention and Control of Medical Devices Using Nanomaterials

文章通过了解目前应用纳米材料类医疗器械产品情况,评估应用纳米材料类医疗器械产品的风险并提出相应的控制措施,以掌握目前应用纳米材料类医疗器械产品的风险,探讨提升应用纳米材料类医疗器械产品质量的策略。可知,已上市的应用纳米材料类医疗器械产品应从纳米材料、生产检验过程及人员等方面进行风险评估和质量控制。建议完善应用纳米材料类医疗器械的法规体系建设,加强审评人员和对检查人员专业知识培训及风险识别能力,探索创新监管模式,促进应用纳米材料类医疗器械的高质量发展。

By understanding the current situation of medical devices using nanomaterials,the risk assessment and control of medical devices using nanomaterials were carried out.To master the risks of the current application of nanomaterials in medical devices,and explore strategies to improve the quality of the application of nanomaterials in medical devices.It can be concluded that,at present,risk assessment and quality control should be carried out in terms of nanomaterials,production inspection process and personnel.It is suggested to improve the construction of the regulatory system for the application of nanomaterial medical devices,strengthen the ability of reviewers and inspectors to identify risks at the level of professional knowledge training,explore innovative regulatory modes,and promote the high-quality development of the application of nanomaterial medical devices.