Obtain Medical Device Manufacturing License

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and post-market compliance matters, as well as the specific provisions governing customized medical devices.

Activities related to medical devices in the People’s Republic of China (PRC)[1], including their manufacturing, marketing, distribution, and sale, are mainly regulated by the Regulations on Supervision and Administration of Medical Devices (the Regulations) promulgated by the State Council and most recently amended in May 2017. The National Medical Products Administration (NMPA) is the governmental authority principally responsible for the supervision and administration of medical devices in the PRC.  

Medical devices in the PRC (including manufacturing, marketing, and sale) are subject to a mandatory filing/registration regime regulated by the NMPA. The exact filing pathways are mainly determined by the classification of such devices – similar to the United States, a three-class classification system, from Class I (lowest risk) to Class III (highest risk). Local testing and clinical trials are generally required for Class II and Class III devices. Some imported devices may need to be registered with a higher level government authority than domestic devices.

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