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【CODEX】无源医疗器械产品原材料变化评价指南(1-2)

无源医疗器械产品原材料变化

评价指南

Guidance for the Review of Changes in Raw Materials of

Non-active Medical Devices

 

医疗器械产品获批上市后,持证人为进一步提高产品质量,常需要对产品的生产设备、原材料、生产工艺、检验方法、质量控制标准等进行改变。持证人建立有效的变更控制程序是确保生产管理体系持续改进以实现生产高质量产品的关键,也是医疗器械质量管理体系中的重要环节。根据质量管理体系要求,持证人应对变化对最终医疗器械产品可能带来的影响进行充分评估,并实施有效的变更控制,以将变化引起的风险降低至可接受范围。

In order to further improve the quality of the medical devices, the licensees usually need to make changes in the manufacturing equipment, raw materials, manufacturing process, inspection method and quality control standards of the products after the approval for marketing. The establishment of an effective change control procedure by the licensee is the key to ensuring continuous improvement of the manufacture management system to achieve high quality products, which is also an important link in the quality management system for medical devices. According to the requirements of quality management system, the licensee shall fully evaluate the impact of the changes on the final medical device product and implement effective change control to reduce the risk caused by the changes to an acceptable level.

 

一般来说,变更控制程序包括变更的发起、分析、评审、验证、确认、审批、实施等环节,其中,根据不同变化内容进行分析、验证和确认是企业应着重完成工作,对需进行审评审批的变更事项,这也是技术审评环节的重点关注。

In general, the change control procedures include the proposal, analysis, review, verification, validation, approval and implementation of the change. Among them, analysis, verification, and validation according to different changes are the key works to be completed by the company, as well as the focus of the technical review for change items requiring review and approval.

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