CFDA注冊(cè)

CFDA Registration

依據(jù)《醫(yī)療器械生產(chǎn)監(jiān)督管理辦法》，

在中國(guó)境內(nèi)開辦第二類和第三類醫(yī)療器械生產(chǎn)企業(yè)，

必須獲得醫(yī)療器械生產(chǎn)企業(yè)許可證。

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.

依據(jù)《醫(yī)療器械注冊(cè)管理辦法》，

任何生產(chǎn)企業(yè)希望在在中國(guó)境內(nèi)銷售、使用醫(yī)療器械(包含境內(nèi)和境外的器械)，

都應(yīng)當(dāng)向相應(yīng)的食品藥品監(jiān)督管理部門進(jìn)行注冊(cè)。

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.

我們的服務(wù)

Services 

◆ 申請(qǐng)策略咨詢，制定相應(yīng)的整體解決方案

     Application strategy consulting and establish application protocol.

◆ 編寫產(chǎn)品技術(shù)要求

     Prepare product technical requirements

◆ 編寫或指導(dǎo)編寫NMPA 醫(yī)療器械注冊(cè)申報(bào)材料

     Complete the registration dossier

◆ 協(xié)助企業(yè)與NMPA進(jìn)行溝通

    Communication with corresponding administration

◆ 協(xié)助獲得醫(yī)療器械經(jīng)營(yíng)企業(yè)許可證

     Assist you in obtaining Medical Device Distributing License

◆ 協(xié)助獲得醫(yī)療器械生產(chǎn)許可證（境內(nèi)企業(yè)）

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

◆ 提供代理人(Legal Agent) 服務(wù)（境外企業(yè)）

     Act as your Legal Agent (overseas firms)