Objective:Determine the evaluation method of blood glucose meter service life analysis,providing technical guidance for improving the quality of registration and regulatory efficiency.Methods:Refer to domestic and international public information on this type of product,consult the relevant documents of the technical review guidelines issued by the Technical Review Center of the State Food and Drug Administration to summarize the experience of the review of the use of stability studies.Results:Based on the"Guidelines for Technical Review of Active Medical Device Term Registration",this study presents three ways to evaluate the term of use of blood glucose meters.Conclusion:Manufacturers should pay special attention to product life verification and confirmation.The evaluation method of service life analysis has no fixed form,and the manufacturer can choose the appropriate evaluation method according to the enterprise situation,and can also combine multiple evaluation paths.
blood glucose meterevaluation of the service lifeaccelerated aging
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NSTL
万方数据
