In accordance with the requirements of the Rules for the Unique Device Identification Rules System for Medical Devices and the arrangement of the Pilot Work Plan for System of Unique Device Identification for Medical Devices, the unique device identification database is officially put into operation on December 10, 2019, and the data declaration function of the unique identification for pilot varieties is opened for pilot enterprises.
1. Build Master Data of Unique Identification
The unique device identification for medical devices consists of product identification and production identification. The unique device identification database for medical devices will gather the product identification and related data of unique device identification for medical devices. The registration/filing applicant of medical devices shall be responsible for the data declaration, and shall be responsible for the authenticity, accuracy and uniqueness of the data. The unique device identification database will provide the master data of medical devices for the production, distribution and utilization of each link, realizing data homology and standardization.
2. Promote Linkage of Whole Chain
In accordance with the requirements of “exploring the connection and application of standardized coding during registration, procurement, use and other links of high-value medical consumables” in the Reform Plan for Governance over High-value Medical Consumables, the code field of medical insurance and the classification of consumables and devices are added in the unique device identification database for medical devices, so as to promote the linkage of whole chain of medical devices from the source production to clinical use, realize sharing of multi-party data, and boost the “linkage of medical-, insurance- and medicine reforms”.
3. Provide Multiple Service Modes
The unique device identification database for medical devices is built on the principles of standardization, usability, openness and expansibility, with simple and friendly page design and convenient operation. In full consideration user requirements, it provides such data declaration methods as webpage declaration, template import and interface docking, and such data sharing methods as webpage online query, data batch downloading and interface docking, so as to facilitate all kinds of users to choose declaration and sharing methods according to the actual needs, providing good experience for users.
4. Open Column for Unique Device Identification System
To facilitate the public to inquiry the development of the construction of the unique device identification system for medical devices, the column of “Unique Device Identification System for Medical Devices” of our website is opened (as shown in Figure 1). Click to enter the column, the relevant policies and regulations, work condition, operating guide of database, etc. (as shown in Figure 2) can be inquired. And you can also enter the login page of declaration to unique device identification database (as shown in Figure 3) by clicking the “Entrance of declaration” on this page.
In the next step, we, the National Medical Products Administration, will strengthen the guidance and service for the declaration of unique device identification data for medical devices, and open the query and sharing services of unique device identification database to pilot units in March 2020 according to the arrangement of pilot work.
1. Build Master Data of Unique Identification
The unique device identification for medical devices consists of product identification and production identification. The unique device identification database for medical devices will gather the product identification and related data of unique device identification for medical devices. The registration/filing applicant of medical devices shall be responsible for the data declaration, and shall be responsible for the authenticity, accuracy and uniqueness of the data. The unique device identification database will provide the master data of medical devices for the production, distribution and utilization of each link, realizing data homology and standardization.
2. Promote Linkage of Whole Chain
In accordance with the requirements of “exploring the connection and application of standardized coding during registration, procurement, use and other links of high-value medical consumables” in the Reform Plan for Governance over High-value Medical Consumables, the code field of medical insurance and the classification of consumables and devices are added in the unique device identification database for medical devices, so as to promote the linkage of whole chain of medical devices from the source production to clinical use, realize sharing of multi-party data, and boost the “linkage of medical-, insurance- and medicine reforms”.
3. Provide Multiple Service Modes
The unique device identification database for medical devices is built on the principles of standardization, usability, openness and expansibility, with simple and friendly page design and convenient operation. In full consideration user requirements, it provides such data declaration methods as webpage declaration, template import and interface docking, and such data sharing methods as webpage online query, data batch downloading and interface docking, so as to facilitate all kinds of users to choose declaration and sharing methods according to the actual needs, providing good experience for users.
4. Open Column for Unique Device Identification System
To facilitate the public to inquiry the development of the construction of the unique device identification system for medical devices, the column of “Unique Device Identification System for Medical Devices” of our website is opened (as shown in Figure 1). Click to enter the column, the relevant policies and regulations, work condition, operating guide of database, etc. (as shown in Figure 2) can be inquired. And you can also enter the login page of declaration to unique device identification database (as shown in Figure 3) by clicking the “Entrance of declaration” on this page.
In the next step, we, the National Medical Products Administration, will strengthen the guidance and service for the declaration of unique device identification data for medical devices, and open the query and sharing services of unique device identification database to pilot units in March 2020 according to the arrangement of pilot work.
For original text and document, please refer to original Chinese website
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