Medical technology, drugs, and medical devices are the three pillars of the medical service system. Medical devices involve sound, light, electricity, magnetism, imaging, materials, mechanics and other industries and nearly a hundred professional disciplines. It is an internationally recognized high-tech industry. It has the characteristics of high-tech intensiveness, extensive cross-discipline, and technological integration, which represents the comprehensive strength of a country's high-tech. In recent years, the medical device industry has developed rapidly, new technologies and new products emerge one after another, product diversity and complexity continue to increase, and the phenomenon of uncoded or multiple codes for medical devices in circulation and use is common, seriously affecting the production, circulation, and production of medical devices. It is difficult to achieve effective supervision and management of medical devices by accurately identifying them in all aspects including use.

Unique Device Identification (UDI) is the ID card of a medical device. The unique identification system of a medical device consists of a unique identification of a medical device, a data carrier and a database. Assigning ID cards to each medical device, realizing the transparency and visualization of production, operation and use, and improving the traceability of products is an important starting point for the innovation of medical device supervision methods and the improvement of supervision efficiency. The bottom line and assisting the high-quality development of the medical device industry will all play a positive role. Therefore, the construction of a unique identification system for medical devices in my country is urgently needed.

The unique identification of medical devices is the focus and hot spot in the field of international medical device supervision. In 2013, the International Medical Device Regulators Forum (IMDRF) issued guidelines for the unique identification system for medical devices. In the same year, the United States issued regulations on the unique identification system for medical devices, requiring seven years to fully implement the unique identification of medical devices. In 2017, the EU legislation required the implementation of unique identification of medical devices, and countries such as Japan, Australia, and Argentina also carried out related work one after another, and the global unique identification of medical devices continued to advance.

In 2012, the State Council issued the "Twelfth Five-Year Plan" National Drug Safety Plan, which required "starting the national unified coding of high-risk medical devices". In 2016, the State Council issued the "Thirteenth Five-Year Plan" National Drug Safety Plan, requiring "to build a medical device coding system and formulate medical device coding rules." In 2019, the General Office of the State Council issued the "Key Work Tasks for Deepening the Reform of the Medical and Health System in 2019", requiring "the formulation of rules for the unique identification system for medical devices", which was deliberated and approved at the eighth meeting of the Central Comprehensive Deepening Reform Committee, and issued by the General Office of the State Council In the "Reform Plan for Governance of High-value Medical Consumables", it is clearly proposed to "formulate rules for the unique identification system for medical devices". In July 2019, the State Food and Drug Administration and the National Health and Health Commission jointly issued the "Medical Device Unique Identification System Pilot Work Plan", which opened the prelude to the construction of my country's medical device unique identification system.