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非無菌凝膠敷料産品是否需進行使用穩定性研究

关于“非無菌凝膠敷料産品是否需進行使用穩定性研究”的问题，醫療器械审评中心（审评五部2024-04-07）给出了明确的规定：如非无菌的无定形凝胶敷料开封后可在申請人规定的使用期限/使用次数内使用，建议对其开封后的使用稳定性进行研究。为确认各型号、规格产品开封后，在实际使用环境下，经过一段时期仍然能够满足使用要求的最长存放时间，建议按照有效期验证检测项目（除装量），提供研究报告。

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