進口一類醫療器械備案服務

Registration service of imported Class I medical device

服務內容：

備案產品技術要求撰寫輔導及服務（中文）；

備案產品風險管理報告撰寫及輔導服務（中文）；

備案產品臨床評價報告撰寫及輔導服務（中文）；

備案其他文件撰寫及輔導服務（中文）；

產品備案資料提交，備案憑證的領取（中文）。

Service content：

Registration product technical requirements writing guidance and service (Chinese);

Registration product risk management report writing and counseling services (Chinese);

Registration product clinical evaluation report writing and counseling services (Chinese);

Registration other document writing and counseling services (Chinese);

Submission of product registration materials and receipt of registration vouchers (Chinese).

備案人準備材料

The registrant prepares the materials

產品說明書（中文）（至少包括：產品照片、型號規格、結構原理特性、性能參數）；

Product specification (Chinese) (at least including: product photos, model specifications, structural principle characteristics, performance parameters);

產品的性能指標及檢驗方法；生產工藝（工藝流程圖（須注明主要控制點，即關鍵工序和特殊工序）主要組分的具體生產過程）；

product performance indicators and inspection methods; Production process (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);

境外備案人所在國家（地區）醫療器械主管部門出具的允許上市銷售的證明文件；

Certification documents issued by the competent authorities of medical devices in the country (region) where the overseas registrant is located to allow the listing of the device;

境外備案人在中國境內指定代理人的委托書、代理人承諾書及營業執照副本復印件；

A copy of the power of attorney, the commitment letter of the agent and the business license of the agent appointed by the overseas registrant in China;　　

授權委托書；

Power of attorney

中英文翻譯件，原產國文件公證件原文。

Chinese and English translations, original notarized document of origin.

備案流程

Registration process