China UDI Regulations in force - but ...

The regulation that was published by the NMPA and that came into force 2019-10-01 just specifies that UDI regulations are applicable for medical devices as of that date - BUT - the details are missing !


This is the wording of the most important article:



本规则自2019年10月1日起施行。分类实施的具体步骤另行制定并 公布。


Article 18

These Rules shall come into force on October 01, 2019. The specific steps for the implementation of the classification will be separately formulated and published.



The document published under the title 国家药监局关于发布医疗器械唯一标识系统规则的公告 (2019年 第66号) specifies:

- There will be a UDI-DI, UDI- PI and a UDI Carrier that needs to be human and automatic readable

- The UDI carrier will have to be on the device / labelling

- The UDI needs to be unique

- The information concerning the UDI needs to be submitted prior to placing products on the market 

- There will be a local issuance agencies for the UDI-DI

- There will be a UDI-Database

and ends with the afore mentioned article 18.