UDI enables Digital transformation of medical device industry

On December 10, 2019, the Medical Device Unique Identification Database (UDID) organized and constructed by the National Drug Administration was officially launched and put into operation. In the past three years, with the strong support and joint efforts of all parties, various work has been carried out in an orderly manner and achieved good results. With the smooth implementation of UDI for the first and second batches of medical device products, the data volume has rapidly increased. As of the end of June 2022, the total number of UDID data has approached 2 million, an increase of nearly 850000 compared to the end of 2021, and an increase of over 300000 in June alone. According to the requirements of the Announcement on Implementing the Second Batch of Unique Identification of Medical Devices jointly issued by the National Drug Administration, the National Health Commission, and the National Medical Insurance Bureau, starting from June 1, 2022, the implementation scope of the second batch of UDI will be extended to the third class of medical devices (including in vitro diagnostic reagents) based on the first batch of 69 varieties in 9 major categories. After the announcement was released, various parts of the country actively responded, with Tianjin, Hainan, Shanghai, Beijing, Fujian, Guangdong, Hunan, Jilin and other provinces (cities) taking the lead and successively carrying out pilot projects for unique identification throughout the country. An industry reform is sweeping the whole medical device industry, marking that the Digital transformation of the medical device industry has entered a new stage What is UDI

Medical Device Unique Identification (UDI), similar to medical device products; ID&# quo;, It is a set of codes that uniquely identify medical device products, usually attached to medical device products or packaging. It consists of product identification DI and production identification PI, which respectively record static information related to the product and dynamic information related to production. The UDI system is composed of UDI, data carriers, and databases Why implement UDI

In recent years, the medical device industry has developed rapidly, with new technologies and products emerging in an endless stream. The diversity and complexity of products are constantly increasing. The phenomenon of no codes or multiple codes for one item is common in the circulation and use of medical devices, which seriously affects the precise identification of medical devices in various links such as production, circulation, and use of medical devices, making it difficult to achieve effective supervision and management. UDI endows each medical device with an ID card, which helps identify the identity of medical devices in various stages of production, operation, and use. It is an important lever for innovation in medical device regulatory methods and improvement of regulatory efficiency. It will play a positive role in strictly adhering to the bottom line of medical device safety and assisting the high-quality development of the medical device industry

The Four Steps of UDI Implementation

The implementation of UDI mainly includes four steps:

1. Product coding. Enterprises choose code issuing agencies to create DI for products and packaging, and determine the composition of the PI. After the product enters the production process, the enterprise chooses a data carrier to assign UDI information to the product's ontology or packaging. Enterprises can choose appropriate code issuing agencies and data carriers based on factors such as product quality management system and application scenarios

2. Data reporting. According to the requirements of UDI implementation, for varieties that have already implemented UDI, when applying for initial registration, renewal registration, or registration change, the enterprise must submit DI data to the registration management system. Before the product is launched for sale, the enterprise must upload DI and relevant information to the UDI database and be responsible for dynamic maintenance of the data to ensure its authenticity, accuracy, and completeness

3. Data sharing. The UDI database shares DI data with business enterprises, medical institutions, relevant government departments, and the public through various means as needed

4. Data application. The combined use of DI and PI information can achieve precise identification and recording of medical devices in the circulation and use process, which helps to promote the regulation of medical devices; Three Medical Linkages

UDI Implementation Progress

Given that medical devices are classified and regulated according to different risk levels, it is difficult for UDI implementation to quickly cover every medical device product in one go. Therefore, it is necessary to gradually advance by category and stage, gradually expanding from high-risk products to low-risk products

The United States, the European Union, Japan and other countries and regions are actively promoting UDI related work. In China, UDI, as a pry point for the Digital transformation of the medical device industry, its implementation has also been highly valued by relevant government departments. The introduction of the "Rules for Medical Device Unique Identification System" and the "Pilot Work Plan for Medical Device Unique Identification System" in 2019 marked the beginning of the construction of China's medical device unique identification system. The subsequent "Announcement on Deepening the Pilot Implementation of the First Batch of Medical Device Unique Identification Work" and "Announcement on Doing a Good Job in the Second Batch of Medical Device Unique Identification Work" clarify the scope, work requirements, and schedule of the first and second batch of UDI implementation varieties. The newly revised "Regulations on the Supervision and Administration of Medical Devices" were released in March 2021, which clearly implemented the unique identification system for medical devices step by step based on the category of medical device products, marking the official entry of a new stage of legal and rule-based implementation of UDI in China. In April of the same year, the Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Construction of Drug Supervision Capacity proposed to gradually implement the unique identification of medical devices and strengthen the connection with medical management, medical insurance management, and other related areas. Starting from January 1, 2021, the first batch of 69 medical device varieties in 9 major categories will be successfully implemented through UDI. Starting from June 1, 2022, the third category of medical devices has also achieved full UDI coverage

UDI's future achievements are expected

The implementation of UDI is the trend of the times, and it is expected to further expand the connection and application of UDI in medical, medical insurance and other fields in the future, and further promote the development of; Three Medical Linkages

From an industrial perspective, the implementation of UDI will help enterprises to make Digital transformation, establish a product traceability system to improve enterprise management efficiency, and promote high-quality development of the medical device industry; Helping circulation enterprises establish a modern logistics system, achieving transparency, visualization, and intelligence in the medical device supply chain; It helps medical institutions to strengthen risk control in the clinical use of medical devices, reduce device usage errors, and ensure the safety of patient use

From a regulatory perspective, it helps the drug regulatory department to link and accurately regulate regulatory services such as supervision and inspection, product sampling, adverse event monitoring, and product recall; Helping the medical insurance department to accurately identify medical devices in procurement bidding and combat fraud and abuse; Helping to improve the management efficiency of medical device bidding and procurement, import customs clearance, and other processes; Helping medical device regulatory authorities to build big data for medical device regulation, enabling traceability of medical device sources, accountability, and promoting the process of intelligent regulation

With the implementation of UDI, I believe that this digital, networked, and intelligent&quo; Wisdom; Tools will definitely help accelerate the modernization process of regulation and bring a leap forward to scientific regulation of medical devices. (Wang Yanbo)