Medical device unique identification database nationwide announcement, maximum transparency!

Medical Device Unique Identification (Unique Device Identification, abbreviated UDI) is the electronic ID card for medical device products. In the context of the information age, UDI is an advanced means of international medical device regulation, a "common language" for global traceability of medical devices, indicating that medical devices can be traced and monitored throughout their entire lifecycle, from production and processing to circulation, distribution, and use!
 

On August 9, 2019, the National Medical Products Administration issued a "Notice on the Pilot Training of the Medical Device Unique Identification System" (hereinafter referred to as the "Notice").  

The Notice states that to ensure the smooth implementation of the "Pilot Program for the Medical Device Unique Identification System", the National Medical Products Administration will lead the organization of training on the medical device unique identification system pilot program. The training targets enterprises at all stages of the medical device industry! It is worth noting that among the pilot program participants for the medical device unique identification system, domestic and international giants such as Roche, Abbott, Beckman, BD, Siemens, and Dian Diagnostics are included! (List of enterprises attached at the end)  AboutUDI Coding Rules 

A heart valve from MedtronicGS1 UDI label example

In the upper right corner of the label, the "barcode" + "the string of characters below the barcode" constitutes the UDI information of the product. (In addition to barcodes, the carrier of UDI information can also be QR codes or radio frequency identification.)  Generally speaking, the UDI information on the label must meet two basic requirements: it must be machine-readable and human-readable. To meet machine readability, simply using standard UDI carriers can achieve machine readability. So, how can the string of characters below the barcode meet the requirement of human readability? This requires a further understanding of the GS1 coding rules.

GS1 Coding Rules UDI consists of two parts: one is DI (Device Identifier), and the other is PI (Production Identifier). For the PI (Production Identifier) part, manufacturers can choose one or more combinations of production date, batch number, expiration date, and serial number according to the product's production management method. For example, for disposable syringe products, the production identifier usually includes batch number and expiration date information. For the DI part, if you want to understand the specific coding rules, you need to refer to an international standard: ISO/IEC 15420, which has also been equivalently converted domestically as GB 12904-2008.  

Promoting consumables,IVD "volume procurement" fully implemented!

 Earlier, the State Administration for Market Regulation issued the "Rules for the Medical Device Unique Identification System (Draft for Comments)", clarifying that the National Medical Products Administration is responsible for establishing the medical device unique identification system, formulating and issuing the implementation plan for the medical device unique identification system, promoting the active application of medical device unique identification for management, and achieving data interconnection. This means that it is likely to be implemented nationwide in the future, and the National Medical Products Administration will formulate relevant standards and specifications for medical device unique identification data, and organize the establishment of a medical device unique identification database for public inquiry.  In addition, this means that the medical device unique identification database will be publicly announced nationwide, all links and information will be traceable and verifiable, and the information of the entire supply chain of medical devices and the IVD industry will be maximized transparency!  On June 27, the National Healthcare Security Administration issued the "Notice on the Guiding Opinions on Medical Security Standardization Work, Medical Insurance [2019] No. 39". The National Healthcare Security Administration requires that the coding of medical insurance medical consumables must be "unique" to achieve a single code throughout the national medical insurance system! The single code also requires the functions of "unified procurement and payment", "supporting data analysis and sharing", and "facilitating hospital clinical management". See the article "Orthopedics Takes the Lead, the Era of Nationwide Unified Coding Arrives, Consumables Must Be "Licensed"  It is worth noting that in the classification of unified coding for medical consumables issued by the Medical Insurance Bureau on June 27, there is no clear indication that in vitro diagnostic products are included, but only a little more than a month later, the in vitro diagnostic industry is already piloting unique identification coding! This also reflects from the side that the national government departments are deepening and strengthening the standardized management of the entire medical device field!   Before the nationwide unified coding, the standard measurement of "volume procurement" of in vitro diagnostic reagents is a complex process, because each manufacturer uses different reagent raw materials, core components of the product, and cost control. However, after the implementation of the medical device unique identification, the speed of nationwide implementation of "volume procurement" of reagent consumables will be greatly accelerated!

Implementation Status of Unified Coding

As early asFebruary 2017, the "Notice on the National Food Safety Plan and the National Drug Safety Plan of the 13th Five-Year Plan" issued by the State Council clearly proposed to formulate medical device coding rules and build a medical device coding system. Breaking the information blockade and independent operation of production, operation, use, and supervision.  In various provinces and cities across the country, Shanghai has implemented the mandatory use of unique identification codes for implantable medical devices since 2006, and uploaded hospital usage data to a city-wide unified traceability management system.  By 2011, third-party logistics and storage operations of medical devices were also included, and the circulation field became a key regulatory object. Beijing, Hunan, Hebei, and Liaoning have already established electronic supervision platforms for medical device logistics, and Chongqing has established a "two-invoice system" electronic traceability supervision system to strengthen the supervision of medical device circulation traceability.  This pilot program started in July 2019 and is divided into five phases: the first phase determines the pilot varieties and participating units; the second phase organizes the verification of the creation and assignment of medical device unique identifiers; the third phase organizes the verification of the functions of the medical device unique identification database and data upload, download, and interface standards; the fourth phase organizes the verification of inter-departmental connection and extended application of unique identification data; the fifth phase organizes a pilot summary meeting, forms a pilot report, and perfects the implementation plan for the first batch of products with unique identifiers.  Establishing a unique identification system, strengthening source coding, and achieving full-chain traceability and identification of medical devices through unique identification to strengthen the management of the entire life cycle of medical devices is of great significance to improving regulatory efficiency and social governance capabilities. The launch of the pilot program marks an important step for China's medical device regulatory system towards scientific, legal, international, and modern development. The joint pilot program by the two departments is conducive to forming a full-chain linkage from source production to clinical use, achieving data sharing, and promoting the linkage of medical insurance, medical treatment, and medical care.

Strengthening the supervision of the entire life cycle of medical devices, initially establishing a medical device unique identification system, and achieving demonstration application of unique identification in production, operation, circulation, and useExploring the formation of a full-chain linkage from source production to final clinical use, continuously accumulating experience, laying the foundation for the later full implementation of the medical device unique identification system, improving the regulatory efficiency and health management efficiency of medical devices, effectively ensuring public safety in the use of medical devices, and promoting the formation of a new pattern of medical device regulatory governance.  

 Attachment:List of Pilot Enterprises for Medical Device Unique Identification System