Medical Device Unique Identification Database Goes Online

The medical device unique identification database is an important component of the medical device unique identification system. In accordance with the requirements of the "Medical Device Unique Identification System Rules" and the arrangements of the "Pilot Program for the Medical Device Unique Identification System," the medical device unique identification database officially went online on December 10, 2019, opening up the function of reporting unique identification-related data for pilot varieties to pilot enterprises.

I. Constructing Unique Identification Master Data

The medical device unique identifier consists of a product identifier and a production identifier. The medical device unique identification database will gather the product identifiers and related data of the medical device unique identifiers. The medical device registrant/filer is responsible for data reporting and the authenticity, accuracy, and uniqueness of the data. The unique identification database will provide master data for medical devices to various stages such as production, circulation, and use, realizing data homogeneity and unified standards.

II. Promoting Whole-Chain Linkage

In accordance with the requirements of the "Reform Plan for the Governance of High-Value Medical Consumables" to "explore the connection and application of standardized codes in the registration, procurement, and use of high-value medical consumables," the medical device unique identification database has added medical insurance code fields and the classification of consumables and equipment to promote the linkage of the entire chain from the source production of medical devices to clinical use, realizing multi-party data sharing and promoting "three medical linkages".

III. Providing Multiple Service Models

The medical device unique identification database adheres to the principles of standardization, ease of use, openness, and scalability. The page design is simple, friendly, and easy to operate. Based on a full consideration of user needs, it provides data reporting methods such as web reporting, template import, and interface docking, as well as data sharing methods such as online web queries, batch data downloads, and interface docking, allowing various users to choose their own reporting and sharing methods according to their actual needs and providing a good user experience.

IV. Opening a Unique Identification System Column

To facilitate the public's access to the development of the medical device unique identification system, the "Medical Devices" section of the National Medical Products Administration website has opened a "Medical Device Unique Identification System" column (as shown in Figure 1). Clicking to enter allows you to check relevant policies, regulations, work dynamics, database operation guides, etc. (as shown in Figure 2). You can also Enter the unique identification database reporting login page through the "Submission Entry" on this page (as shown in Figure 3).

Next, the National Medical Products Administration will strengthen guidance and services for medical device unique identification data reporting and, according to the pilot work arrangements, open the unique identification database query and sharing services to pilot units in March 2020.

Figure 2