医疗器械质量管理中存在的问题及完善策略研究
Research on Issues in Medical Device Quality Management and Improvement Strategies
医疗器械质量的好坏直接影响到公众用械安全和产业高质量发展，2025版医疗器械生产质量管理规范实施之后，行业质量管理进入了全生命周期动态合规的新阶段。目前我国医疗器械企业质量管理普遍存在着体系落地形式化、风险管理机制不健全、数字化管控能力不足、供应链质量管控缺失等状况，从而影响到产品质量的改善以及行业合规的提升。本文立足于行业实际，根据最新的监管要求以及行业的实际情况，分析问题产生的原因，从体系闭环、风险前置、数字赋能三个方面提出相应的完善策略，为医疗器械企业优化质量管理体系、适应新规要求提供实践参考。
The quality of medical devices directly impacts public safety in device usage and the high-quality development of the industry. Following the implementation of the 2025 Medical Device Manufacturing Quality Management Specification, industry quality management has entered a new phase of dynamic compliance throughout the entire lifecycle. Currently, Chinese medical device enterprises generally face issues such as formalistic system implementation, inadequate risk management mechanisms, insufficient digital control capabilities, and gaps in supply chain quality control, which hinder product quality improvement and industry compliance enhancement. Based on industry realities and the latest regulatory requirements, this paper analyzes the root causes of these problems and proposes corresponding improvement strategies from three dimensions: system closure, risk mitigation, and digital empowerment, providing practical guidance for medical device enterprises to optimize their quality management systems and adapt to new regulations.
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