12 June 2021
How to register your medical devices in China
China has a very potential market for your medical devices mainly due to a large population. Moreover, especially for the innovative high-end devices, China still relies on import. The export of your medical devices to China is one of the market entry modes. It allows for faster market entry and requires relatively lower capital investment.
As in Europe, China imposes rather strict rules on medical devices than on other products as those are human health-related and risks involved. Medical devices in China are mainly regulated by the National Medical Products Administration (NMPA), which has been recently revised and has taken effect as of June 1, 2021.
Prior to commercializing your medical devices in China, you need to register your devices, or namely obtaining certain approvals from the NMPA according to the NMPA regulation. The revised regulation to a certain degree simplifies the procedure. Generally speaking, the following steps need to be taken for the registration of your medical devices at the NMPA.