In order to implement the Circular of the General Office of the State Council on Issuing the Reform Scheme for the Governance of High-value Medical Supplies (GBF [2019] No. 37), the National Medical Products Administration released the Rules of Unique Device Identification System and, together with the National Health Commission of the PRC, piloted the unique device identification system. On October 14, National Medical Products Administration issued the Announcement on Matters Related to the Implementation of the First-batch Unique Device Identification (hereinafter referred to as the Announcement) The Announcement specifies the variety scope, schedule and working requirements for the implementation of the first-batch unique device identification. According to the Announcement, the unique device identification will be required for manufacturing the medical devices included in the first-batch implementation catalog since October 1, 2020.
According to the level of risk and supervision needs, the Announcement defines the high-risk Class III medical device as the variety of implementation of the first-batch unique device identification, including partial active implantable and passive implantable. Nine categories, containing 64 varieties, are included in the product catalog of implementation of the first-batch unique device identification, including cardiac pacemakers, hip joint prostheses, injectable filler for plastic surgery, etc.
According to the requirements of the Announcement, as for medical devices included in the first-batch implementation catalog, the registrant shall code the unique identification and submit the unique identification registration system and unique identification database in accordance with the requirements of the Rules on schedule. According to the Announcement, the unique device identification will be required for manufactured medical devices since October 1, 2020; it is not required for medical devices manufactured before October 1, 2020. The date of manufacture is subject to the labels of medical devices.
According to the requirements of the Announcement, in case of applying for first registration, continuous registration or registration change, the applicant for registration/registrant shall submit the product identification of stock keeping unit in the registration management system since October 1, 2020. Product identification is not a review item of registration, and its individual changes are not within the scope of registration change.
In addition, according to the Announcement, for medical devices manufactured from October 1, 2020, the registrant shall upload their product identifications of stock keeping unit and higher level package and related data to the unique device identification database before selling on the market in accordance with relevant standards and specifications; if there is any change in related data of the product identification of stock keeping unit, the registrant shall make changes in the unique device identification database and update the data before selling on the market. If there is any change in product identifications of stock keeping unit of medical devices, the data of new-added product identification shall be uploaded to the unique device identification database.
Meanwhile, according to the requirements of the Announcement, the first-batch registrants implementing the unique identification shall organize the coding, data uploading and maintenance as required, and shall also be responsible for the authenticity, veracity and integrity of data; registrants are encouraged to establish an information traceability system for medical devices by applying the unique device identification, achieving the traceability of production, circulation and application of products; enterprises manufacturing and operating medical devices and their application organizations are encouraged to apply the unique device identification in related management activities, so as to explore and establish trace chains with upstream and downstream, thus promoting cohesive application; relevant departments shall organize training and publicity activities.
According to the level of risk and supervision needs, the Announcement defines the high-risk Class III medical device as the variety of implementation of the first-batch unique device identification, including partial active implantable and passive implantable. Nine categories, containing 64 varieties, are included in the product catalog of implementation of the first-batch unique device identification, including cardiac pacemakers, hip joint prostheses, injectable filler for plastic surgery, etc.
According to the requirements of the Announcement, as for medical devices included in the first-batch implementation catalog, the registrant shall code the unique identification and submit the unique identification registration system and unique identification database in accordance with the requirements of the Rules on schedule. According to the Announcement, the unique device identification will be required for manufactured medical devices since October 1, 2020; it is not required for medical devices manufactured before October 1, 2020. The date of manufacture is subject to the labels of medical devices.
According to the requirements of the Announcement, in case of applying for first registration, continuous registration or registration change, the applicant for registration/registrant shall submit the product identification of stock keeping unit in the registration management system since October 1, 2020. Product identification is not a review item of registration, and its individual changes are not within the scope of registration change.
In addition, according to the Announcement, for medical devices manufactured from October 1, 2020, the registrant shall upload their product identifications of stock keeping unit and higher level package and related data to the unique device identification database before selling on the market in accordance with relevant standards and specifications; if there is any change in related data of the product identification of stock keeping unit, the registrant shall make changes in the unique device identification database and update the data before selling on the market. If there is any change in product identifications of stock keeping unit of medical devices, the data of new-added product identification shall be uploaded to the unique device identification database.
Meanwhile, according to the requirements of the Announcement, the first-batch registrants implementing the unique identification shall organize the coding, data uploading and maintenance as required, and shall also be responsible for the authenticity, veracity and integrity of data; registrants are encouraged to establish an information traceability system for medical devices by applying the unique device identification, achieving the traceability of production, circulation and application of products; enterprises manufacturing and operating medical devices and their application organizations are encouraged to apply the unique device identification in related management activities, so as to explore and establish trace chains with upstream and downstream, thus promoting cohesive application; relevant departments shall organize training and publicity activities.