Blog
China UDI Requirements
Unique device identifier refers to a series of codes constituted of numbers, letters and/or symbols and established on the basis of standards. Unique device identifier, which includes product identifier and production identifier, is used for unique identification of medical devices. The National Medical Products Administration (NMPA), China’s medical device market regulator, has published official Unique Device Identification (UDI) requirements that will take effect October 1, 2019. China’s UDI requirements are similar to those in the US and European Union. They establish specific device ID and labeling requirements, as well as a central, state-administered database of devices.
Data elements required
Most of China NMPA data elements are common with US FDA, some are exactly the same, others are unique to China. Medical Insurance Number, Nomenclature codes, classification numbers are examples that differ. An understanding of the differences up front will help streamline the assignment of data elements.
In China, the manufacturing date is ‘always’ visible on the product label whereas in the US, no manufacturing date is required on the label. The date format is specific with exact day requirement: YYYY-MM-DD.
Note: After submission, Device Identifier (DI) and some key elements are not editable. After being published, data changes will require a request for approval to change.
Part of the required China UDI data elements are included with the NMPA Product Certificate: Product name, device description and classification NMPA Product Certificates Number, notation (per manufacturer) concerning the UDI-DI consistency with the registered UDI-DI, applicant name, product catalog consumable/capital equipment, and Device catalog Devices or IVD.
Submission process
Amendments & Annual process
- Select UDI Issuing Agency (GS1 China most popular)
- Generate UDI according to the established Agency rules
- Submit UDI in Registration System (early on, included in registration process)
- Select UDI carrier and apply on the product/package
- Upload UDI to UDI Database (link: https://udi.nmpa.gov.cn/)
- Maintenance of data for changes
- The code issuing agency shall have certified legal entity in china. Currently the agencies include: GS1 China, Zhongguancun Industry & Information Research Institute of Two-Dimensional Code Technology, Ali Health, Mashangfangxin Platform, etc.
- Agencies must provide their standards implementation processes to registrants and guide manufacturers’ implementation efforts;
- Agencies must upload their coding standards to China’s UDI database and maintain that data;
Amendments & Annual process
- Annual reports from code agencies should be submitted to NMPA by January 31 of each year
- Within 30 working days after the user changes, upload the product identification and related data to database of unique identifiers for medical devices.
Explore Topics
- Clinical Automation (5)
- event1 (1)
- IRT & CLinical Supplies (2)
- Labeling (1)
- Regulations (1)
- Regulatory Automation (3)
- Regulatory Information Management (4)
- UDI (1)
- Uncategorized (5)
- Writing (6)
Recent Blogs
- Regulatory Impact Assessment; How are you handling…April 5, 2024
- Mexico: Modifications to Medical Device Registrati…November 8, 2023
- Is Regulatory Team Overworking but Unproductive?November 7, 2023