家用医疗器械监管模式研究

Research on the supervision and administration model of home medical equipment

目的:探究家用医疗器械监管模式,以保证家用医疗器械产品的研发和应用安全有效。方法:通过参考国外家用医疗器械监管经验,梳理家用医疗器械监管范围,识别出非医疗环境和非专业人士使用的主要风险,提出以产品设计说明书为抓手控制产品风险的监管措施。结果:通过实施家用医疗器械监管措施,提升了家用医疗器械厂家的产品说明书编写水平,能够100%识别出具有家用医疗器械特征的产品,有效提高了监管部门对家用医疗器械的监管能力。结论:实施家用医疗器械产品风险监管措施,能够有效提高监管部门对家用医疗器械的监管能力,保障家用医疗器械使用的安全性。

Objective:To explore the supervision and administration model of home medical equipment to ensure the safety and effectiveness of research and development and application of home medical equipment.Methods:By referring to the foreign experience in the supervision and administration of home medical equipment,the scope of supervision and administration of home medical equipment was sort out,non-medical environment and major risks used by non-professionals was identified and the supervision and administration measures for product risk control by taking product design instructions as a starting point were proposed.Results:Through the implementation of the supervision and administration measures for home medical equipment,the level of product manual compilation of home medical equipment manufacturers was improved,the products with home medical equipment characteristics can be identified 100%,and the supervision and administration ability of the regulatory authorities on home medical equipment was effectively improved.Conclusion:The implementation of risk supervision measures for home medical equipment can effectively improve the capacity of regulatory authorities in supervising household medical devices,and ensure the safety of home medical equipment.