China's first medical device "electronic ID card" will land all real name system

Huang Libin introduced that since the outbreak, the cumulative supply to Hubei transferred medical protective clothing reached more than 7.7 million pieces, isolation clothing, surgical clothing reached more than 2.8 million pieces, medical isolation eye mask son mask reached more than 1.6 million, killing supplies reached more than 2,200 tons, infrared thermometer nearly 700,000 units, medical equipment reached 80,000 units (sets)the current overseas epidemic is still very serious, the need for epidemic prevention and control has greatly accelerated the global circulation of medical devices, at the same time, also make the traceability of medical devices is particularly importantat present, China's medical device unique identification database is officially open to the public to share, the public, medical device enterprises and medical institutions can be used for queryNot only that, in October this year, the State Drug Administration will organize the implementation of the pacemaker, coronary stent and other 9 categories of 64 medical device varieties of the unique identification workthis means that China's first medical device "electronic ID card" will land, after landing each medical device will be able to trace back to the source, real name system"electronic ID card" for medical devices is the unique identification of medical devices (Unique Identification Device, or UDI)before, medical devices in the circulation of the use of no code or one thing multi-code phenomenon is widespread, seriously affecting the production, circulation, use of medical devices and other links of the accurate identification of medical devices, it is difficult to achieve effective supervision and managementand the implementation of UDI, it is expected to achieve "one weapon, one code one identity", from the source of production, operation and circulation, to clinical use of all links "one-yard unicom."China in 2019 clearly put forward the "development of medical device unique identification system rules", and then, "medical device unique identification system pilot work program," medical device unique marking system rules, on the first batch of implementation of the medical device unique identification work related matters, such as a series of intensive introduction, proposed to use July 2019 to July 2020, the implementation of medical device unique identification pilot workparticipated in the pilot units, including Beijing University First Hospital and other 108 medical institutions and National Pharmaceutical Group Medical Devices Research Institute Co., Ltdand other 116 medical device enterprisesand to promote the udi pilot application, to achieve data aggregation and sharing is an important prerequisite, for this reason, the State Drug Administration co-ordinates the construction of a unique identification database of medical devices, the collection of product identification (DI) and related data,at the same time developed the "Medical Device Unique Identification Database Basic Data Set" "Medical Device Unique Identification Database Filling Guide" 2 standardsit is understood that in the early stage of database construction, the State Drug Administration has done a lot of research and demonstration work, in the process of setting standards to organize production enterprises, operating enterprises, hospitals, code agencies and other units of personnel to form a group of experts to carry out data items, after consulting several times, in order to meet the actual needs of enterprises and units of use, while taking into account the international common practice, so that the unique identification of China's medical devices in line with the "international language" standardsDecember 10, 2019, the unique identification database of medical devices was officially launched, and the reporting function was opened to the pilot enterprisesMarch 31, the database further open database sharing function, to query, download, interface docking and other three ways, for the public, medical device production and operation enterprises and medical institutions and other parties to query and usefrom December 2019 to June 2020, only the data declaration function will be open to pilot enterprisesthe unique identification database of medical devices has been growing since the launch of the unique identification database, and more than 243,000 data have been collected, of which 92.34 percent are device products and 7.66% are in vitro diagnostic reagentsthe State Drug Administration said that the promotion of the unique marking of medical devices has been included in the State Drug Administration's 2020 key work, especially from October, will organize the implementation of the unique logo of 9 categories of 64 medical device varieties, simultaneous research and development of the second batch of implementation varieties and policiesthe first 64 varieties to implement the unique identification, including pacemakers, vascular stents, joint prosthetics and plastic fillers and other implantable products, are high-risk category 3 medical devicesIn accordance with the Rules of the Unique Identification System for Medical Devices, these 64 medical device products after October 1, 2020 must have a unique identification of medical devices and upload relevant data to the unique identification database of medical devices before they can be listed for saleand before the first UDI implementation in October, it is also important to carry out publicity, training, pilot and other preparations for the relevant partiesThe State Drug Administration said that the next step will continue to strengthen the training, sum up the udi pilot work experience, in preparation for the formal implementation of UDIat the same time, will continue to strengthen communication and coordination with the National Health and Health Commission, the National Health Insurance Administration, and actively expand the udi application in medical and health care work, to promote the "three medical linkage."in fact, the implementation of the unique logo of medical devices is a positive innovation for regulators, consumers, medical institutions and the entire medical device industrythrough information disclosure and data sharing, government management can achieve transparent traceability, intelligent supervision, medical institutions can reduce the use of weapons errors, improve the level of related managementAnnex 1 is the list of pilot enterprises, Annex 2 is the list of pilot hospitals
(original title: Heavy! Medical device ID card is coming, all real name system)