China Simplifies Registration Requirements for Domestic Production of Medical Devices That are Currently Imported

China’s National Medical Products Administration (NMPA) has issued an announcement regarding the production of medical devices that are currently imported, but such foreign enterprises intend to produce such devices in China under the same medical approval licence previously approved by the competent mainland authorities (NMPA Announcement No. 104 [2020]). Registration of such devices will be accepted provided that the product design remains unchanged, the quality is consistent and there are no obvious changes in safety or efficacy. This is intended to streamline examination procedures and save applicants the trouble of submitting the same documents again.

Applicants should ensure that the correct production processes are used to manufacture the products in China and give their word that there will be no changes to the principal raw materials used.

Source: National Medical Products Administration