|
|
Application of Medical Device NMPA Registration In China, regulatory requirements for medical devices are detailed in Regulations for the Supervision and Administration of Medical Devices, while the regulatory authority is the National Medical Products
Administration (NMPA).
According to the Administrative Measures for Medical Device Registration and Filing issued by the NMPA, for the medical devices are sold and used in the People’s Republic of China, Class I medical devices are subjected to product filing management, and Class II and Class III medical devices are subjected to product registration management. Our Services： Application strategy consulting
Develop application solution
Obtain the Medical Device Production License*
Compile the Product Technical Requirements
Communicate with medical device testing center on your behalf
Compile registration dossier for your product
Communicate with the NMPA on your behalf
Obtain the Medical Device Business License
Legal Agent service**
* This service is only applicable to manufacturers located in China
** This service is only applicable to manufacturers located outside of China |
Copyright©www.mid-link.net,All rights reserved.
检验检测·法规咨询·质量体系·CDMO·医学检验
400 821 7661 sales@mid-link.net
天津市经济技术开发区第九大街51号融达科技园B座一层