國產(chǎn)一類醫(yī)療器械備案服務(wù)

Registration service of domestic Class I medical device

備案產(chǎn)品技術(shù)要求撰寫輔導(dǎo)及服務(wù)；

產(chǎn)品檢測（自測）； 質(zhì)量管理體系輔導(dǎo)；

產(chǎn)品備案資料撰寫及輔導(dǎo)服務(wù)；

產(chǎn)品備案資料提交，備案憑證的領(lǐng)取。

Registration product technical requirements writing counseling and services；

product testing (self-testing)；

quality management system counseling,；

product registration information writing and counseling services,

Submitted product registration materials and received registration vouchers.

國產(chǎn)一類醫(yī)療器械備案

Registration of domestic class I medical device  　　

備案人準(zhǔn)備材料： 　　

產(chǎn)品說明書（至少包括：產(chǎn)品照片、型號規(guī)格、結(jié)構(gòu)原理特性、性能參數(shù)）； 　　

產(chǎn)品的性能指標(biāo)及檢驗方法；生產(chǎn)工藝提供（工藝流程圖（須注明主要控制點，即關(guān)鍵工序和特殊工序）主要組分的具體生產(chǎn)過程）；

授權(quán)委托書。

The registrant prepares the materials：

product specifications (including at least: product photos, model specifications, structural principles characteristics, performance parameters);

product performance indicators and inspection methods; Production process provision (process flow chart (must indicate the main control points, that is, key processes and special processes) of the main components of the specific production process);

Power of Attorney.

備案流程

Registration process