Mandatory Fields for China NMPA UDI Database Filing and New Rules

NMPA approved BRAF mutation detection kits
August 6, 2020
China NMPA Delayed UDI Implementation Date to Jan 1st, 2021
September 30, 2020

Mandatory Fields for China NMPA UDI Database Filing and New Rules

Last year, NMPA issued a number of UDI related policies regarding the UDI implementation. There is a UDI database portal (https://udi.nmpa.gov.cn) established which includes sections of Filing entrance, UDI regulations, UDI news, Database operation user manual, Data declaration manual, Data docking manual, Q&A, and Issuing agents & rule.

Details related to your questions can be found from Medical device unique device identification management information system user manual (Trial Version) – Dec, 2019 (Here is the link to the manual in Chinese). We’ve also confirmed with NMPA that following fields are locked once the record has been published:

  1. Device identifier on the minimum sales unit (primary DI) 
  2. DI coding system name
  3. Public Release Date
  4. Quantity per minimum sales unit

Additional information can be added to following 2 fields later on, just be aware that original data is not editable once the record is published.

  1. Registration/Filing Certificate Number (Note: If we have received a new license, we could add the new license number to the original license)
  2. Packaging Data (Package UDI-DI/ Packaging Level / Packaging DI/ Quantity per Package / Contains UDI-DI ) (Note: If the product has multiple level packaging and we would like to add a higher level packaging, we could certainly add that information, but the original package level data is not editable.)

Please note that UDI has to be included in the initial submission starting on October 1, 2020. The license holder shall upload the product identification data to the China UDI database within 60 days after the product is approved or renewed, and before the commercialization of the product. if multiple UDI change applications are submitted to NMPA and have not yet gone through approval process, the system will only document the latest change application. After change applications are approved, there will be historical versions available for review.  

Here is a list of regulations and standards that have published so far. English translations are available upon request.

  • Guiding Opinions on Medical Security Standardization (June 20, 2019)
  • Notice regarding the Information Maintenance for Reimbursed Drugs and Medical Consumables (June 25, 2019)
  • Work Plan for the Pilot of Unique Device Identification System (July 3, 2019)
  • Interpretation of Rules for Unique Device Identification System (August 3, 2019)
  • First Group of Unique Device Identification Devices (Draft) (September 17, 2019)
  • GB/T 33993-2017 Product QR Code (July 12, 2017)
  • YY/T 1630-2018 Basic Requirements for Unique Identification of Medical Devices (November 27, 2017)
  • GB/T 12905-2019 Barcode Terminology (March 25, 2019)
  • YY/T 1681-2019 Basic Terminology of the Unique Identification System for Medical Devices (July 24, 2019)
  • YY/T 1752-2020 Basic Data Set of Medical Device Unique Identification Database (July 9, 2020)
  • YY/T 1753-2020 Guidelines for Filling in the Unique Identification Database of Medical Devices (July 9, 2020)