What Is the Medical Device UDI and Why Do You Implement UDI?

  Author:MeCan Medical–ultrasound machine manufacturers

Medical Devices Model 1 Identification (UDI), which refers to the code that is included in the medical device products or packaging, which is included on the medical device product or packaging. Product's electronic ID card.

Article 7 of the "Medical Devices Weiming 1 Idential System Rules" stipulates that "Medical Devices Weifang only include product logos and production logo. The product logo is the only one code for identifying registered registered/recorder, medical device model specifications and packaging; The composition of the code related to the production process of the medical device, according to supervision and actual application needs, can include medical device serial numbers, production batch numbers, production date, failure date, etc. "So why should you implement UDI?

The major medical device systems include security, trackability, and efficiency in the introduction of UDI's introduction. This is because UDI can quickly and clearly identify the key attributes of equipment safety and effectiveness. Its implementation will reduce the obstacles to the lack of medical device recognition in the market, quickly and accurately identify the key information of the safety and effectiveness of equipment, and reduce the medical errors caused by it.

When the illegal situation of medical device products occurs, it can be automatically identified and accurately tracking through UDI to force the production enterprise to strictly control the quality during the production and sales process, so as to identify product problems more effectively, and faster quickly Earth recall the problem equipment to ensure the safety of patients.

Implementing the only 1 logo is the real needs of the development of digital industries in the era of globalization and informatization. It is the real needs of improving supervision efficiency and social governance capabilities, so that Chinese medical device products can better move towards the world.

What Is the Medical Device UDI and Why Do You Implement UDI? 1

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