四川医疗器械产品质量监督抽验现状及对策探讨

目的：探索四川医疗器械产品质量监督抽验优势与不足,促进产品质量监管的规范化、制度化。方法：通过文献查阅,到质量监管部门调研与访谈,分析影响因素,提出思考与对策。结果：四川产品质量监督取得显著成绩的同时,在抽验品种数、范围和抽样任务等方面不适应产品发展需要。结论：要保证产品质量,必须扩大抽验范围、增加样品来源、提高抽验人员素质、强化政府监管职能,才能促进四川医疗器械健康发展。

Discussion on Countermeasures and Status of Quality Supervision and Random Inspection of Medical Devices in Sichuan Province

Objective：To explore the strengths and weaknesses of Sichuan Medical Devices Product Quality Supervision and sample testing,and promote the standardization and institutionalization of product quality supervision.Methods：To consult references,research and cover the quality supervision department,analyze the influencing factors,and put forward thinking and countermeasures.Results：Remarkable achievements have found their way in Sichuan Product Quality Supervision,while the varieties,the range and tasks of product samples are not suited to the development of products.Conclusion：In order to ensure the quality of products,we must expand the scope of random testing,increase the source of samples,improve the quality of personnel,and strengthen the government＇s regulatory functions.Only in this way can we promote the healthy development of medical devices in Sichuan.