Medical Device Industry

Unique Device Identification (UDI) is the electronic ID card for medical devices.

What principles should be followed in UDI implementation?

The "Unique Device Identification System Rules" (hereinafter referred to as the "Rules") require that the construction of the identification system should actively draw on international standards and follow the principles of government guidance, enterprise implementation, coordinated advancement, and phased implementation. To better promote international exchanges and trade and optimize the business environment, China's medical device identification system construction has drawn on internationally accepted principles and standards. In building the identification system, the government plays a guiding role, and the registrant/filer, as the responsible party, implements it and actively uses the identification to improve product quality and management levels. Due to the diversity and complexity of medical devices, phased implementation of identification is an international common practice. Compared with the United States and Europe, China's implementation of medical device identification includes a pilot phase, focusing mainly on high-risk implantable/interventional medical devices, with a smaller coverage to ensure steady progress of the rules.

How to achieve UDI data aggregation and sharing?

The aggregation and sharing of medical device identification data are realized through the Unique Device Identification Database, which is established by the National Medical Products Administration. The registrant/filer uploads the product identifier and related information of the identification to the database in accordance with relevant standards and specifications and is responsible for the accuracy and completeness of the data. Medical device distributors, medical institutions, relevant government departments, and the public can share identification data through data query, download, data interfacing, and other methods.

Is it necessary to assign an identifier?

From the effective date of the "Rules", registrants/filers should submit their product identifiers in the registration/filing management system when applying for relevant medical device registration, registration changes, or handling filing. The relevant medical device products should be assigned identifiers during the production process, and the upload of product identifiers and related data for the medical device identification should be completed before the product is marketed and sold.

Medical devices that have been produced and sold before the effective date of the "Rules" may not have a medical device identifier.

How to choose a data carrier for medical device identifiers?

Commonly used data carriers on the market include barcodes (one-dimensional), QR codes (two-dimensional), and radio frequency identification (RFID) tags. One-dimensional barcodes are symbols that represent information in one dimension. They have been maturely applied for many years, with low cost and good compatibility with existing scanning devices. However, one-dimensional barcodes occupy more space and have poor damage correction capabilities. Two-dimensional codes represent information in two dimensions, allowing more data to be accommodated in the same space compared to one-dimensional barcodes. They are particularly useful when medical device packaging is size-limited, have certain error correction capabilities, but require higher-quality reading equipment than one-dimensional barcodes. RFID tags have information storage capabilities, can receive electromagnetic modulated signals from readers, and return corresponding signals as data carriers. The cost of RFID carriers and reading equipment is higher than that of one-dimensional barcodes and two-dimensional codes, but RFID tags have fast reading speeds and can be read in batches, making them useful in certain processes and fields. Registrants/filers can choose an appropriate data carrier for medical device identifiers based on factors such as product characteristics, value, and main application scenarios.