GS1 standard helps the smooth implementation of the unique identification of medical devices in China

"Standardizing the construction of UDI system can not only improve the level of refined management of medical devices, but also effectively improve medical quality and maintain patient safety." The UDI system is the basis for realizing the unified, standardized, refined and scientific management of medical devices. Recently, at the "Public Welfare Training on the Implementation of Medical Device Unique Identification (UDI) System Rules" held by the China Article Coding Center, a representative from the hospital said.

What is UDI?

UDI is the English abbreviation of Unique Device Identifier, which is a series of codes composed of numbers, letters or symbols created based on standards to identify medical devices globally and is the basis for accurate collection of medical device life cycle data.

Medical devices are related to human health and life safety, and countries around the world attach great importance to it, and have introduced management systems to ensure the standardized application of medical devices.

As early as 2006, China carried out positive and beneficial exploration of UDI, and the Shanghai Food and Drug Administration issued a document in conjunction with relevant departments to strengthen the management of implantable medical devices, requiring the use of international standards to uniquely identify medical devices, and centrally establish a medical device database to trace medical devices throughout the process. In 2012, the "Twelfth Five-Year Plan for National Drug Safety" proposed to start the national unified coding of high-risk medical devices, and clearly proposed the formulation of medical device coding rules and the construction of a medical device coding system in the 13th Five-Year Plan.

Internationally, in December 2013, the International Medical Device Regulators Forum (IMDRF) issued the UDI Guidelines, which provided a recognized technical framework proposal for the global implementation of UDI and kicked off the global implementation of UDI.

UDI protects the safety of public devices

Since the issuance and implementation of the Rules for the Unique Identification System for Medical Devices in August 2019, the State Food and Drug Administration, the National Health Commission and the National Health Insurance Administration have jointly issued several announcements to gradually promote the construction of the UDI system in accordance with the risk level and regulatory needs of medical devices, improve the quality supervision of the whole chain of medical devices from source production to final clinical use, and ensure the safe use of devices by the public.

On January 1, 2021, the first batch of unique identification of medical devices in China was fully implemented.

UDI is the "electronic ID card" of medical devices, and is an important starting point for the innovation of medical device regulatory means and the improvement of regulatory efficiency. On the one hand, UDI's ID card function can realize the transparency and visualization of the complete chain of medical devices from source production to final clinical use, improve product traceability, and on the other hand, through medical product information disclosure and data sharing, consumers can use and understand consumption with confidence, and effectively protect the legitimate rights and interests of consumers.

According to the official website of the State Food and Drug Administration, 103 varieties of Class II medical devices will be implemented UDI as the third batch of medical device varieties from June 1, 2024.

The GS1 standard meets global UDI requirements

GS1 standard is the most widely used standard system in the world, committed to improving the efficiency and safety of the entire supply chain, and is widely used in more than 20 fields such as FMCG, medical, logistics, e-commerce, and food. UDI based on GS1 standard is the most widely used in the world, and GS1 standard is currently the only standard that meets the relevant requirements of UDI, medical device traceability, medical device procurement and other related requirements published by all countries (regions) in the world.

A globally harmonized UDI based on GS1 standards helps to achieve traceability of medical devices, accurately identify medical devices during distribution and use, reduce medical errors, and accurately record and collect medical device data to improve patient safety.

China actively draws on international standards. In August 2019, the State Food and Drug Administration issued the Rules for the Unique Identification System for Medical Devices, which clearly stated that "the construction of the unique identification system for medical devices should actively learn from international standards" and "encourage coding institutions to adopt relevant international standards to establish a unique identification operation system".

At present, GS1 standard is the only standard system in China that can meet the domestic circulation and export needs of medical devices at the same time, and the enterprises with China Article Coding Center (GS1 China) as UDI coding agencies account for 93% of the total number of enterprises implementing UDI. Since the State Food and Drug Administration launched the implementation of UDI, the coding center has successively issued the "UDI Implementation Tutorial" and "Implementation Guide for Unique Identification (UDI) of Medical Devices Based on the Commodity Barcode (GS1) Standard" to fully support China's medical device manufacturers, circulation enterprises and medical institutions to better implement UDI and traceability. So far, the GS1 standard UDI implementation public welfare training held by the coding center has reached 44 online and offline sessions, with nearly 500,000 training times, which has been well received by all aspects of society.

GS1 standards help China's medical device supervision and the healthy development of the industry

The UDI system based on GS1 standard is conducive to the use of information technology to achieve rapid and accurate identification of medical devices in production, operation and use. It is conducive to the sharing and integration of product regulatory data; It is conducive to innovating regulatory models and improving regulatory efficiency; It is conducive to strengthening the management of the whole life cycle of medical devices. Help enterprises and hospitals meet regulatory requirements, improve the level of information management, and help improve the level of refined clinical management and risk management and control capabilities of hospitals.

UDI based on GS1 standard has obvious effects in supporting the modernization of China's medical device industry chain, maintaining supply chain stability, and helping the government to supervise smartly.

Shandong Zhushi Pharmaceutical Group Co., Ltd., founded in 2003, has more than 5000 registered employees. After years of development, it has developed into a diversified industrial cluster integrating medical devices, polymers, cosmetics, health food, daily necessities and biological reagent production, enterprise management consulting and training, real estate economy, pharmaceutical transportation, pharmaceutical printing, etc.

Adhering to the concept of life, health and happiness, the Group provides you with full chain health services.

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