1-医用敷料国际市场发展状况与质量风险20140707 - 中国医用敷料 .ppt

CFDA中国食品药品监督管理局对医疗器械行业的要求增加：刚刚生效的《医疗器械监督管理条例》在企业注册，生产质量管理的要求上作出更加严格的要求。 Control and Management for Medical device company from China FDA also enhanced: more stringent requirements on registration, production and quality management requirements are added “Supervision and Regulation of Medical Devices.“ which just effect on June 2014. 敷料行业的质量风险/Quality Risks in wound Care Industry CM 主管当局的要求-中国/Authority Demands--CFDA 持续的欧债危机导致就业率低下，贸易保护主义抬头。惯用质量壁垒限制中国企业出口。 The European debt crisis led to sustained low rate of employment, trade protectionism. Preferred Quality barriers restrict the export of Chinese enterprises. 敷料行业的质量风险/Quality Risks in wound Care Industry CM 主管当局的要求-欧洲/Authority Demands--EU 日益增强的品质要求VS持续下行的市场价格压力 Quality requirements increasing VS Price of quotation decreasing 客户成本压力下,企业被迫以牺牲品质来保住订单与份额。产品设计设定上受成本因素左右，潜在的质量风险逐步聚集。如纱布平方米克重，成形尺寸… Under cost down pressure, companies are forced to sacrifice quality to hold market share. Design of products are constrained by cost ,some of the product characteristics are set on spec boundary, company run under risks… 敷料行业的质量风险/Quality Risks in wound Care Industry CM 客户质量要求/Customer Quality Requirements 产品无菌与功能性保障 产品无菌性保障除了灭菌工艺经过严格验证以外，产品的生产环境控制初始污染菌对于无菌保障亦不可忽视。 在受控的生产环境下，消毒与非消毒产品未严格分区产生的交叉污染，生产人员的微生物控制，设备，材料的微生物水平都会导致出现有极端风险的微生物增加（致病菌）的发生。 The sterilization of products not only rely on robust sterilization cycle validation, but also the production environment control play significant part. For eg. Bioburden level control is critical for sterilization. 敷料行业的质量风险/Quality Risks in wound Care Industry CM 客户质量要求/Customer Quality Requirements 产品核心质量功能丧失 Lose of Critical to Quality 在所有医疗产品中，产品核心质量即功能性质量要求是客户重点关注的部分，敷料企业的产品质量需从终端客户感受作为输入.部分产品功能性丧失有医疗事故的风险:如入手术室产品的功能缺失等. In all medical products, product CTQ requirements that are main part of the customer focus, product quality addressing customers needs and expectation as input to quality improvements. For eg. Some products have a functional defects could make high sev