实施《医疗器械生产质量管理规范》加强对初包装材料的管理

目的 保证医疗器械包装材料的质量能够满足医疗器械的要求.方法 结合《直接接触药品的包装材料和容器管理办法》对药品包装材料产品注册、生产洁净度以及注册品种等管理要求展开讨论.结果与结论 提出加强医疗器械初包装材料选择和生产管理方面的合理化建议.

Strengthen Administration of Primary Packaging According to Good Manufacturing Practice for Medical Devices

Objective To ensure the quality of packaging materials of medical devices can meet the requirements of medical devices.Methods It was researched about primary package materials of medical devices product on good manufacturing practice for medical devices,discussed about capability,sterilization compatibility,cleanliness and associated controlled environments,using the experience of registration regulations of pharmaceutical packaging materials and containers for a reference.Results and Conclusion It was suggested strengthening the administration of manufacturing for primary package materials of medical devices.