All medical devices which are sold in Chinese market must be under supervision of National Medical Products Administration (NMPA). The manufacturers of imported medical device must obtain the registration certificates issued by NMPA for their products. At the same time, it is necessary to open an office or designate an agent in China to ensure all submitted materials meet the requirement of NMPA regulations.

Registration application service is always the core business of MedicalStrong from its establishment. Our service is mainly for those products such as active, passive, implant medical device (Class Ⅰ/Ⅱ/Ⅲ). The service items cover initial registration, renewal of registration, alteration of registered items, alteration of license items, filing and alteration filing, registration testing agency etc. We have built good relationship with many technical review institutions , the testing centers/institutions in Beijing, Tianjin, Shenyang, Jinan, Wuhan, Shanghai, Hangzhou, Guangzhou etc. Until now, our registration & testing team is formed by 20 professional personnel. Their average career of the registration is more than 2.5 years and the projects which are been operating by them simultaneously are no more than 15. At the same time our professional management will ensure efficiency of all projects.

Service Items

Classification Application

Innovative Medical Device Application

Technical Requirements development

Registration Testing Agent Service

Clinical Investigation Document development

Formatted documents arrangement

Communication with NMPA reviewers