Time confirmed! The medical device ID card will be issued immediately. The strictest supervision is coming.

Medical NetworkSeptember 10th news - 20 days countdown, do you understand these coding rules? Currently, the first batch of 116 pilot medical device companies and 108 pilot hospitals have been announced. (List attached at the end of the article)

　　Electronic ID card is about to be launched

　　Recently, according to the official website of the National Medical Products Administration, the pilot work of the unique identification system for medical devices has entered a substantive stage. Xu Jinghe, vice director of the National Medical Products Administration, pointed out that the establishmentof the UDI system, strengthening the source coding, and realizing the full chain traceability and understanding of medical devices from the source production to clinical use.

　　According to the official website of the Drug Administration, fromOctober 1, 2019, all medical devices sold and used within China will implement Unique Device Identification (UDI).

　　So, what exactly isUDI? Is it the regulatory traceability code seen on medicine boxes?

　　UDI is the abbreviation of Unique Device Identification, which is a unique device identification given to medical devices throughout their lifecycle. It is the unique "ID card" in the product supply chain.

　　What can this code check?

　　In short,UDI coding can be used in product manufacturing, warehousing, logistics,hospitalsconsumable management, national adverse event monitoring, product recall and other product life cycle processes to achieve automatic identification and accurate traceability. It is in the entire supply chain.

　　Among them, the device identifierDI belongs to static information. It is the identity identifier of medical devices in the supply chain and can be used as a "keyword" to query the basic traceability information of the product in the database.

　　The production identifierPI belongs to Trends. It includes the serial number, batch number, production date and expiry date of the medical device product, which is the dynamic additional information of the medical device product. It must be used in conjunction with DI to point to a specific medical device product.

　　How to code a large number of consumables?

　　Medical consumables have always been a concern in the medical community due to the difficulty of coding.

　　Unlike drugs, consumables are not only numerous but also diverse. The same product in different regionsBiddingThe names of procurement are different, and local regulations on consumables vary widely, which brings many inconveniences to the Bidding and procurement and payment links.

　　Based on this, the standardized development of the industry urgently needs the emergence of coding standards for medical consumables.

　　The National Healthcare Security Administration recently announced the "Coding Rules and Methods for Four Items of Information Business: Medical Insurance Disease Diagnosis and Surgical Operations, Drugs, Medical Service Items, and Medical Consumables," which demonstrates the coding of medical insurance medical consumables:

　　Medical insurance medical consumables coding is divided into5 parts, a total of 20 digits, represented by uppercase English letters and Arabic numerals in a specific order. The first part is the consumable identification code, the second part is the classification code, the third part is the generic name code, the fourth part is the product characteristic code, and the fifth part is the manufacturer code. The rules are as follows:

　　The first part is1 letter: Consumable identification code, represented by the uppercase English letter "C".

　　The second part is6 numbers: Classification code, classified according to the discipline, Applications, location, and function of medical consumables;

　　The third part is3 numbers: Generic name code, creating a nationally unified generic name code for medical insurance medical consumables;

　　The fourth part is5 numbers: Product characteristic code, code assigned according to the material and Specification of the consumable;

　　The fifth part is5 numbers: Manufacturer code, a unique code assigned to the consumable manufacturer based on the medical device registration certificate or filing certificate.

　　Linked to medical insurance settlement and clinical practice

　　Since it plays a role in regulating the industry, the emergence of coding standards will inevitably change and correct certain links in the consumable industry chain.

　　The most concerning thing for distributors is medical insurance settlement and hospital payment.

　　According to the "Pilot Work Plan for the Unique Identification System of Medical Devices" issued by the National Medical Products Administration, a unique identification system framework for medical devices will be established. Realize the creation and assignment of unique identifiers for medical devices, as well as data upload, download and sharing functions, form a unique identifier database for pilot medical devices, and establish a unique identifier data platform.

　　In the trial stage, it will be initially applied in various links such as the production, operation, circulation and use of medical devices.

　　As we all know, medical devices often inevitably encounter some adverse events and product recalls. The unique identification system will begin to use its tracking and tracing function.

　　It should be pointed out that the unique identification system will also be connected and applied in the fields of health and medical insurance, and data sharing will be realized among information platforms such as registration and approval, clinical application, and medical insurance settlement.

　　Therefore, in the future, the Bidding, procurement, and payment links of consumables will become more and more transparent. This transparency also means that supervision will be more refined and deepened, and opportunities for exploitation will gradually decrease.

　　116 medical device companies and 108 hospitals will conduct pilot programs first

　　At present, many medical device companies have been testing the waters. Recently, the nationaldrugThe Supervision and Administration Bureau issued the "Notice on ConductingMedical DevicesTraining on the pilot program of the unique identification system." Training will be conducted fromAugust 27 to 28, 2019.

　　From thecompaniesthat participated in the training, you can see that there are a total ofAmong the 116 enterprises are industry giants such as Medtronic and Stryker. At the same time, the list of 108 medical institutions for the first batch of pilot programs has also been released.

　　  (Attachment 1 is the list of pilot enterprises, Attachment 2 is the list of pilot hospitals)