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A Road Map To China s Medical Device Registration Process By May Ng and Ren Dazhi, ARQon China has one of the most promising medical markets and its healthcare industry is currently the second largest in the world, following closely behind the U.S. From 2015 to 2019, the CAGR for the Chinese medical devices market has increased significantly, and it is expected to continue rising even more in the next four years due to the growing population, the escalating prevalence of diseases and disorders, and many other factors. Therefore, the Chinese medical device market is highly sought after. Medical device approval is required to be obtained from the National Medical Products Administration (NMPA) (see ARQon’s website here for more information). The pre-market or product registration procedures are different for imported products and local domestic products.

Ren dazhiZhejiang medical products administrationTechnical committee of national medical clinical laboratoryOffice for startupDrug administrationChina drug administration research associationSingapore manufacturing federation medtech industry groupSingapore health sciences authorityNational medical products administrationMedical device evaluationFlow chartImported medical deviceDomestic medical deviceDomestic manufacturerAsia regulatoryEquality consultancy