Implementation of the unique identification (UDI) of medical devices in countries around the world
Unique Device Identification (UDI) is the electronic ID card of medical device products. In the context of the information age, UDI is an advanced means of international medical device supervision and a "common language" for medical devices to achieve global traceability.
In recent years, the national drug regulatory authorities have actively promoted the application of UDI in my country's medical device field, and issued the medical device industry standard "Basic Requirements for Unique Identification of Medical Devices" on December 20, 2018. The standard will be implemented on January 1, 2020. At present, some companies are already exploring UDI. In March this year, Shandong Weigao Group Medical Polymer Products Co., Ltd. announced the implementation of the UDI system, completed the UDI coding of all products, established a UDI database, and realized data sharing and interaction, which also indicates that my country's medical devices are about to enter the UDI era.
Unique Device Identification (UDI) is a hot topic in the field of international medical device supervision and a development direction for innovation in regulatory means and improvement of efficiency. UDI is an important basic work. In the era of informatization, Internet+, and big data, the current hot topics in the regulatory field, such as traceability system construction, real-world evidence, and medical device re-evaluation, are closely related to UDI. Establishing a UDI system is an effective way to achieve smart supervision.
The predecessor of the International Medical Device Regulators Forum (IMDRF), the Global Medical Device Harmonization Task Force (GHTF), established the UDI Special Working Group in 2008 and passed the "Guidelines for the Unique Identification System of Medical Devices" (hereinafter referred to as the "Guidelines") in September 2011. In 2012, IMDRF replaced GHTF and supplemented and passed the "Proposed Rules for the Unique Identification System of Medical Devices" on the basis of the "Guidelines". It is expected that regulatory authorities around the world will build their own UDI systems in accordance with the proposed rules. At present, UDI continues to be implemented under the new global framework of IMDRF, and has been actively promoted in developed countries and regions such as the United States, the European Union, and Japan.
The United States: First to Implement UDI
In 1999, the Institute of Medicine of the United States published a research report titled "To Err is Human, Institute of Medicine 1999". The report pointed out that the incorrect use of drugs and medical devices is one of the main causes of medical accidents. Barcodes can effectively avoid and reduce the misuse of medical devices, thereby greatly reducing social costs. In 2004, the U.S. Food and Drug Administration (FDA) promulgated regulations requiring the use of barcodes on drug labels. During the drafting stage of the regulations, the FDA publicly solicited opinions on whether this regulation should be extended to medical devices, but during the review of the regulations, the FDA decided not to apply this rule to medical devices because medical devices lack standards and unique identification systems similar to the National Drug Code system.
Although the regulation decided not to apply drug barcodes to medical devices, the FDA did not give up the exploration of UDI, because the FDA realized that unique identification not only helps reduce medical errors, facilitate recalls, identify device compatibility or allergic reactions (such as MRI and latex), but also helps improve inventory control, improve reimbursement methods and reduce counterfeit products. To this end, the FDA actively carried out relevant research to promote the implementation of UDI. The FDA Amendment Act of 2007 established the legislative basis for the implementation of the UDI system; the FDA Safety and Innovation Act of 2012 clarified the time frame for the implementation of the UDI system; in September 2013, the FDA issued the Medical Device Unique Identification System Regulations, which clearly required the gradual implementation of UDI in stages according to product risk levels over a period of 7 years until all products were fully covered. During this period, the FDA also issued a number of guidelines to guide companies to comply with regulatory requirements and adjusted the implementation date of some types of products. At present, all Class III and Class II medical devices in the United States have implemented UDI, and Class I and unclassified medical devices will be implemented from September 2020.
In the process of implementing UDI, the FDA set up a special UDI team and established a UDI consultation system (UDI Helpdesk) to answer relevant questions encountered by companies during implementation. The FDA opened the database upload function when the regulations were issued in September 2013, and opened it to the public in May 2015. As of February this year, the database has more than 2 million master data.
EU: Establish a large database platform
In April 2013, the EU issued a proposal for a common framework for the unique identification system of medical devices, intending to implement the UDI system throughout the EU. In May 2017, the EU issued regulations on medical devices and in vitro diagnostic reagents, stipulating that only medical device products with UDI can legally enter the EU market and circulate freely. According to regulatory requirements, the EU will gradually implement UDI over a period of six years from 2021, according to the type and risk level of medical device products, until all varieties are covered.
It is worth noting that the UDI system database in the United States is a single module, while the "European Medical Device Database (EudaMed)" to be established by the EU is a large platform that covers multiple areas of the entire life cycle of medical devices. It requires multiple parties to participate in data maintenance and multi-user authority management (regulatory, corporate, public, third-party certification agencies), and the UDI database is only a part of it. Compared with the United States, which only requires companies to input and update data, the EU database system has more participants, better functions and expected effects. However, correspondingly, the EU will also pay higher system construction and maintenance costs for this, and database construction is more difficult. At present, the database is still under construction and is expected to be delivered on March 26, 2020.
Japan: Requests in the form of notifications
Since 2002, the Ministry of Health, Labor and Welfare of Japan has conducted annual surveys on the progress of medical device informatization. In June 2007, the Ministry of Health, Labor and Welfare of Japan implemented regulatory reforms and promoted a three-year plan. In March 2008, it issued the "Notice on the Implementation of Barcode Display for Medical Devices, etc.", with the main purpose of improving logistics and medical insurance settlement efficiency. Within three years after the issuance of the notice, Japan gradually advanced according to the risk level of medical devices, and the Medical Information System Development Center established a database to register information related to medical device barcodes. According to a domestic survey in Japan in 2018, the coding rate of medical device product boxes has reached 96%, the coding rate of single medical device packaging is 88%, the database field upload rate is 77%, and the database field is about 1 million. It is worth noting that Japan put forward UDI-related requirements in the form of a notice, which is mainly driven by distribution, sales and medical insurance reimbursement settlement.
Progress in other countries and regions
In 2012, IMDRF was established and a UDI working group was established in the same year. In 2013, IMDRF issued the "UDI System Guide", which is a framework document on the UDI system. In September 2017, the IMDRF Management Committee approved the "IMDRF UDI Application Guidelines", which is a refinement of the 2013 system guidelines at the implementation level. The final document was adopted at the IMDRF Moscow meeting in March this year.
Among the 10 countries and regions of IMDRF, the United States and the European Union have issued UDI-related regulations, Brazil, China and South Korea have issued draft regulations for comments, and Japan, Canada and Australia have issued UDI-related notices and guidance documents. Among the countries that have signed cooperation documents with China to jointly build the "Belt and Road", Saudi Arabia has issued a draft regulation for comments, and Turkey has established a registration and traceability system database. In South America, countries such as Colombia and Argentina are also actively promoting the implementation of the UDI project. Among them, Colombia has issued a draft UDI-related regulation, and Argentina has issued a medical device traceability regulation.
