NMPA注册

NMPA Registration

依据《医疗器械生产监督管理办法》，

在中国境内开办第二类和第三类医疗器械生产企业，

必须获得医疗器械生产企业许可证。

According to Measures for Supervision and Administration of Medical Device Manufacturing

 issued by NMPA, firms who manufacture Class II and/or Class III medical devices in China

 shall obtain Medical Device Production License.

依据《医疗器械注册管理办法》，

任何生产企业希望在在中国境内销售、使用医疗器械(包含境内和境外的器械)，

都应当向相应的食品药品监督管理部门进行注册。

According to Measures for the Administration of Medical Device Registration issued by NMPA,

 firms who are intended to commercial distribute medical devices (domestic or import devices) in China shall obtain the Medical Device Registration License. Imported medical devices shall be granted with registration license by NMPA.

我们的服务

Services 

◆ 申请策略咨询，制定相应的整体解决方案

     Application strategy consulting and establish application protocol.

◆ 编写产品技术要求

     Prepare product technical requirements

◆ 编写或指导编写NMPA 医疗器械注册申报材料

     Complete the registration dossier

◆ 协助企业与NMPA进行沟通

    Communication with corresponding administration

◆ 协助获得医疗器械经营企业许可证

     Assist you in obtaining Medical Device Distributing License

◆ 协助获得医疗器械生产许可证（境内企业）

     Assist you in obtaining Medical Device Production License (domestic firms)

◆ 提供代理人(Legal Agent) 服务（境外企业）

     Act as your Legal Agent (overseas firms)