Medical device minimum sales unit assignment ID card began to print

Medical network November 30, remind armed enterprises: in the packaging printing should pay attention to anti-counterfeiting, can increase anti-counterfeiting language, to prevent change or coverage, but also to prevent imitation or theft.
1. A few days ago, the Tianjin Drug Administration issued the "Tianjin Medical Device Unique Identification Code Operation Guide (Trial)", which will guide the registrar to carry out the operation of the unique identification code assignment for medical devices.
is a unique label for medical devices? It refers to a code attached to a medical device product or packaging consisting of numbers, letters, or symbols for the unique identification of a medical device.
device unique identification (UDI) includes product identification (DI) and production identification (PI).
a new product identification in the event of a product that may affect medical device identification, retrospective changes, or changes in regulatory requirements.
Medical devices shall be assigned at the minimum sales unit of the product and above, and in-body diagnostic reagent products with multiple components such as passive medical device products, active medical device products containing assemblable or replaceable parts, calibrations or quality control products shall be assigned on the product minimum packaging unit or the product minimum use unit.
Minimum sales unit is the smallest unit for trade items and terminal sales of medical device products, with a separate registration number or filing document number, not necessarily the smallest packaging unit or minimum use unit.
minimum packaging unit is a packaging unit that is in direct contact with the ont body (including components) of a medical device product and may consist of one or more minimum packaging units.
minimum unit of use is the smallest product unit used in a single time and can consist of one or more minimum units of use.
the minimum use unit in the minimum sales unit of the product has an assignment code, it is encouraged to print the UDI of the minimum unit of use on the minimum sales unit packaging and indicate that it is convenient to use the unit sweep code.
use of a unique identification of medical devices at the same time, such as logistics code or product internal traceability code, etc., but should be noted and distinguished.
medical device registrar/filer is the sole responsibility subject of the medical device identification assignment code, medical device business enterprises and user units do not need to assign code.
processes for assigning codes to product labels for 2 and UDI codes? First of all, according to product characteristics, export demand, customer demand and other factors to choose their own coders, can also be selected according to the actual needs of multiple coders for simultaneous use, according to the code of the selected coders to carry out product identification (DI) and production identification (PI) of the assignment, registration and login to the National Drug Administration UDI database, in the database upload product identification information, the process in the completion of product identification Code can be carried out, and then select the appropriate UDI carrier and printing method, UDI code printed on the product identification, label, in the process, Tianjin medical insurance fixed-point pharmaceutical institutions procurement and sale of medical supplies medical device products should complete the two-code mapping filling work, need to choose according to their own capabilities and needs to build UDI-related information system, in the process of use of UDI coding and its use to optimize and improve.
In terms of product identification (DI) assignments, product identification is a unique code for identifying registrars/filer, medical device model specifications and packaging, generally including packaging indicators, vendor identification codes, product item codes, and verification codes.
of the minimum packaging/use unit should be 0, on this basis, the packaging level should be increased in order to adjust the packaging indicator.
when the wrapper indicator changes, the corresponding check code should be recalculated.
registrar/filer shall specify the UDI code correspondence of the sub-packaging contained in the superior packaging, and generate a packaging hierarchical control table according to the actual needs in order to operate the enterprise and use the unit sweep box code into the library.
different models, specifications (including packaging specifications), composition of the product, its product identification should be different and unique.
3. Note that UDI is counterfeited or stolen with special attention to the "Production Identification (PI) Code", a code that identifies information about the medical device's production process, usually including the date of production, the number of production, the date of expiration, and the serial number.
information contained in the product identification should include at least all production-related information included in the product label and logo.
medical supplies passive medical devices that are managed by UDI according to batch number can not add serial numbers to the production identification of the smallest assignment unit.
to encourage the assignment of packaging codes to non-minimum code units, serial numbers are added to their production identification to increase the accuracy of product traceability.
registrar/filer should write serial numbers in accordance with the principle of random generation and avoidance of continuity, in order to prevent serial numbers from being easily guessed resulting in UDI being counterfeited or stolen.
serial number is recommended not to repeat for 5 years.
registrar/filer may add additional information to the production identity, as permitted by the coding rules.
in the data carrier selection, we need to pay attention to the following points.
data carriers include one-dimensional codes, two-dimensional codes, and RF tags.
registrars/filer may determine for themselves according to their actual needs, product packaging size and customer needs.
the data carrier on the packaging can choose to print the packaging in advance, generate the code after printing or paste the UDI carrier label, etc. , to ensure that the medical device during the operation and use of solid, clear, readable.
should pay attention to the anti-counterfeiting of the carrier or increase the anti-counterfeiting language when giving the data carrier on the packaging, and prevent medical device operators from changing or covering the original product UDI without authorization.
data carrier should meet the requirements of automatic identification and data acquisition technology as well as manual reading.
can be used at the same time a variety of carrier forms, the use of one-dimensional code, product identification and production identification can be connected in series, can also be multi-line parallel;
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