依據《醫療器械生產監督管理辦法》，在中國境內開辦第二類和第三類醫療器械生產企業，必須獲得醫療器械生產企業許可證。

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《醫療器械注冊管理辦法》，任何生產企業希望在在中國境內銷售、使用醫療器械(包含境內和境外的器械)，

都應當向相應的食品藥品監督管理部門進行注冊。

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

Services

◆ 申請策略咨詢，制定相應的整體解決方案

Application strategy consulting and establish application protocol.

◆ 編寫產品技術要求

Prepare product technical requirements ◆ 編寫或指導編寫NMPA 醫療器械注冊申報材料

Complete the registration dossier ◆ 協助企業與NMPA進行溝通

Communication with corresponding administration

◆ 協助獲得醫療器械經營企業許可證

Assist you in obtaining Medical Device Distributing License

◆ 協助獲得醫療器械生產許可證（境內企業）

Assist you in obtaining Medical Device Production License (domestic firms) ◆ 提供代理人(Legal Agent) 服務（境外企業）

Act as your Legal Agent (overseas firms)