国产一类医疗器械备案服务

Registration service of domestic Class I medical device

备案产品技术要求撰写辅导及服务；

产品检测（自测）； 质量管理体系辅导；

产品备案资料撰写及辅导服务；

产品备案资料提交，备案凭证的领取。

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.

国产一类医疗器械备案

Registration of domestic class I medical device  　　

备案人准备材料： 　　

产品说明书（至少包括：产品照片、型号规格、结构原理特性、性能参数）； 　　

产品的性能指标及检验方法；生产工艺提供（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）；

授权委托书。

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.

备案流程

Registration process