October 15, 2018
In order to reinforce the supervision and management of the development, production, operation and use of medical devices, NMPA (National Medical Product Administration) has issued the “Draft of UDI Rules for Medical Device” at the end of August with the primary objective of establishing a unique identification system (UDI) for medical devices. This regulation applies to medical devices that are sold and used in China. The NMPA is currently soliciting public opinions with regards to the same, which will be expected to take effect in 2018
This rule specifies the definition and composition. of UDI, and clearly stipulates that the issuing agency shall be a legal entity in China with a complete management and operating system to ensure the uniqueness of the unique identification of medical devices. In the future, the NMPA will be mapping out relevant standards for UDI and will establish a UDI online database for medical devices which shall cater for public inquiries.
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