眠呼吸监测产品技术审评规范(2010版)(国外英文资料).docVIP

眠呼吸监测产品技术审评规范(2010版)(国外英文资料) The technical review specification for sleep apnea (2010) (draft) According to the measures for the administration of medical device registration (order no. 16) of the state food and drug administration requirements and combining with the characteristics of sleep apnea monitoring products, the technical review to regulate sleep apnea monitoring products, formulates this specification. The scope of application This specification is applicable to sleep breath monitoring products. The category of management in the catalogue of medical devices is class II, and the product class is 6821-9. Second, the key points of technical review (1) requirements for the name of the product The principles of this specification are divided into three levels (see table 1) : class A, B and C. Should be named as sleep a-class products, grade B products should be named as sleep apnea products, C grade products should be named as at the beginning of sleep apnea screening products, function is less than the c-class products cannot be named sleep, sleep apnea or at the beginning of sleep apnea screening products. In addition, if the product doesnt have real-time monitoring function, and can only be used for collecting, recording and analysis, the product can only be named as record, not named as monitoring products, but also apply to the product of this specification. For recording products, the necessary analytical software must be registered. Based on the above principle, the product name should reflect the product function or physical properties, such as guide more sleep monitor (corresponding to A level in table 1), sleep apnea monitor (table 1 B), at the beginning of sleep apnea screening instrument (C) in the corresponding table 1. At the same time, the name of the product should be used in the catalogue of the national drug administration. Table 1 sleep breath monitoring product classification Realize the function A grade Class B Class C Commonly used module