March 8th, 2018

The Unique Device Identification (UDI) system is a set of alphanumeric codes that serves to enhance monitoring activities for medical devices. It consists two parts: (1) UDI (an array of alphanumeric codes) and (2) UDI carrier which come in three distinct types: (a) QR code, (b) Bar code, or (c) RFID/NFC. These alphanumeric character sets are intended for storing product information such as the Global Trade Item Number, Expiration Date, Lot Number and Serial Number.

The main objective of the UDI system is to adequately track devices from the point of its manufacture, distribution down to its use. The UDI can standardize the identification of medical devices to strengthen the supervision and management of medical devices at different stages, such as research, production, operation and other aspects of the product life cycle. The UDI system allows the efficient management of medical devices.          

In an effort to align with the international standards, CFDA has released a draft of the UDI system during the last week of February, and is currently seeking for public opinion until the end of April.

The draft consists of five chapters, and the overview of each chapter were hereby summarized as follows:          

·  The 1^st chapter clarifies the purpose of the legislation, the application scope, the definition of UDI, and the relevant responsibilities of CFDA. The UDI system applies to all medical devices distributed in China.          

·   The 2^nd chapter clarifies the definition, structure, basic principles and requirements of the unique device identification.          

·   The 3^rd chapter clarifies the definition and requirements of the unique identification carrier.          

·   The 4^th chapter clarifies the contents and requirements of the unique identification database. Data uploading and database maintenance requirements were also covered in this chapter.          

·   The 5^th chapter contains additional information and are attached as appendices

The applicant shall upload the product identification and other related data to the official UDI database within 30 working days after the product has been approved for registration or change application.          

In the draft, it was also mentioned that the CFDA will be formulating relevant standards for the UDI, and will establish a unique identification database of medical devices for public inquiries.

Reference:

 The draft of UDI system regulation