NMPA launched Unique Device Identification (UDI) Database on its website on August 10, 2020, facilitating the implementation of China UDI system for the first group of devices which will take effect on October 1, 2020. 97,258 device identifiers have already been uploaded to the database.
On the official UDI Database website (https://udi.nmpa.gov.cn/home.html), you can find some manual and instructions for using this database:
- UDI Regulations
- UDI news
- Database operations manual
- Data declaration manual
- Data docking manual
- Q&A
- Issuing agents & rules
The NMPA statistics show that, as of September 3, there were 97,258 identifiers uploaded, 8,031 to be uploaded and 45,347 drafted. Among the total of 151,000 identifiers, 96.96% are devices' and 3.04% are IVDs'.
We do have the English version of the main regulation "Rules for Unique Device Identification". If you are interested, please email me. Since this is the first time required by NMPA, if you have challenges or questions, please let us know, we channel feedback periodically back to NMPA.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------