Medical device unique identification regulations will be implemented soon

In order to achieve the purpose of product anti-counterfeiting, flow tracking, product traceability, precise calling and reducing the occurrence of medical accidents, July 1, 2019, the State Drug Administration (NMPA) and the National Health Commission jointly issued the 'Pilot Work Plan for the Unique Identification System for Medical Devices'. On August 26, the State Food and Drug Administration issued the 'Medical Device Unique Identification System Rules.' On October 14, the 'Notice on Doing a Good Job in the Implementation of the First Batch of Medical Device Unique Identification Work' was issued.

From October 1, 2020, all products sold by the first batch of medical device companies that implement the unique identification of medical devices must have the unique identification of medical devices, otherwise they will not be allowed to go on the market. It is imperative to develop a unique identification of medical devices. Since then, the work of China's unique identification system for medical devices has officially entered a new stage of law-based, rule-based, step-by-step implementation, and organizational guarantees.

Unique Device Identification (UDI) is identified by the device identification code (DI) and production The code (PI) composition is the identification given to the medical device throughout its life cycle, and it is the only 'identity card' in the product supply chain.

The device identification code is a mandatory and fixed code, which contains the information of the label manager, the specific version or model of the device, and there are special regulations, while the production identification code has no special regulations. Contains the device production batch number, serial number, production date, expiration date and a unique identification code as a device management product.

After the implementation of the unique identification of medical devices, the registrant and recorder of the medical device should choose an appropriate carrier form to assign the unique identification of the medical device to the product when manufacturing the medical device. On the body or its packaging. According to the latest data from the National Medical Products Administration, a total of 26,595 medical manufacturers are currently registered/filed, and 116 device manufacturers are the first batch of pilot projects. In the next few years, the application of inkjet marking in the medical device industry will usher in huge business opportunities.

As we all know, clarity and contrast are used to determine whether the packaging of medicines and medical devices is in compliance with regulations and whether it is traceable The key to UDI coding and high-reading rate barcodes, and the quality of printing directly determines the effectiveness of printing data. However, there are many packaging materials for medical device products. The first-level packaging includes metal scalpels, medical dialysis paper, blood bags, kits and other materials; the second and third-level packaging includes corrugated boxes, film-coated cartons and other materials, with different materials. The material has higher requirements for the material adaptability of the coding.

The variable data high-resolution UV cij printer can print various variable data in real time, including bar codes, two-dimensional codes, date and time, counters, LOGO, graphics, and forms , Database, etc., according to different packaging materials and product characteristics, the UV ink with a wide range of material adaptability has been developed, which can fully meet the printing needs of permeable and non-permeable materials, and effectively improve the quality of coded data to meet the specified requirements .

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