Basic Information on the Document

The Rules for the Unique Device Identification System for Medical Devices were issued by the National Medical Products Administration in 2019 Announcement No. 66 on August 23, 2019, and took effect on October 1, 2019. Comprising 18 articles, the Rules are the foundational normative document establishing the Unique Device Identification (UDI) system for medical devices.

System Composition

The Rules specify that the unique device identification system for medical devices consists of three parts: the unique identifier (comprising the device identifier and the production identifier); the data carrier (forms such as bar codes and QR codes that carry the unique identifier code); and the unique device identification database (established by the NMPA and open to the public for query).

Principle Requirements for the Unique Identifier

The unique identifier shall be related to the basic characteristics of the product and must conform to the principles of uniqueness, stability, and extensibility. The device identifier is used to identify the registrant/filer, the model of the medical device, and the packaging; the production identifier includes information such as the serial number, batch number, production date, and expiry date.

Responsibilities of Each Party

The registrant or filer of the medical device is responsible for creating and maintaining the product's unique identifier, applying the data carrier on the product packaging, and bearing responsibility for the authenticity of the data. An issuing agency must be a legal person within the territory of China and may operate only after being recognized by the NMPA. The NMPA is responsible for formulating standards for issuing agencies and for establishing and maintaining the database.

Source: National Medical Products Administration, Rules for the Unique Device Identification System for Medical Devices (2019 Announcement No. 66), Gazette of the State Council on the Chinese Government Website, https://www.gov.cn/gongbao/content/2019/content_5462534.htm; NMPA UDI portal, https://udi.nmpa.gov.cn