进口一类医疗器械备案服务

Registration service of imported Class I medical device

服务内容：

备案产品技术要求撰写辅导及服务（中文）；

备案产品风险管理报告撰写及辅导服务（中文）；

备案产品临床评价报告撰写及辅导服务（中文）；

备案其他文件撰写及辅导服务（中文）；

产品备案资料提交，备案凭证的领取（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).

备案人准备材料

The registrant prepares the materials

产品说明书（中文）（至少包括：产品照片、型号规格、结构原理特性、性能参数）；

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

产品的性能指标及检验方法；生产工艺（工艺流程图（须注明主要控制点，即关键工序和特殊工序）主要组分的具体生产过程）；

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);

境外备案人所在国家（地区）医疗器械主管部门出具的允许上市销售的证明文件；

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;

境外备案人在中国境内指定代理人的委托书、代理人承诺书及营业执照副本复印件；

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;　　

授权委托书；

Power of attorney

中英文翻译件，原产国文件公证件原文。

Chinese and English translations, original notarized document of origin.

备案流程

Registration process