UDI (UniqueDeviceIdengtification) Medical Device Unique Identification.
Background:
l? Since September 24, 2013, the U.S. Food and Drug Administration (FDA) issued the "Final Rule on the Unique Identification System for Medical Devices", the development of the UDI implementation strategy, and the promotion of the implementation of the UDI, the regulatory bodies of many countries and regions have initiated the development of UDI regulations. Work. At present, the European Union, Japan, South Korea and other UDI regulations have been introduced.
l? In July 2019, China's State Drug Administration (hereinafter referred to as "SDA"), together with the National Health Commission (hereinafter referred to as "NHHC"), jointly issued the "Pilot Work Program for the Unique Identification System for Medical Devices", marking China's unique identification system for medical devices. The Pilot Work Program marks the official launch of the pilot work of the UDI system in China;
l? In August 2019, the State Drug Administration (SDA), together with the National Health Commission (NHHC), set up a departmental collaborative working group for the pilot work of the UDI system to further strengthen the organizational leadership and coordination of the pilot work of the UDI system, which has steadily advanced the pilot work.
l? In August 2019, the State Drug Administration issued the Rules for the Unique Identification System for Medical Devices to strengthen the management of the whole life cycle of medical devices, and explicitly required that the registrant/filer should choose the data carrier standard that is compatible with the UDI that it creates, and assign a unique identification to the smallest unit of sale of a medical device listed in its name and the higher level of packaging or medical device products. Ensure that the unique identification is strong, clear and readable during the operation and use of the medical device.
l? On October 12, 2019, the State Drug Administration issued the "Notice on Matters Related to the First Batch of Implementation of Unique Identification of Medical Devices", targeting "some active implantable, passive implantable and other high-risk Class III medical devices" and requesting that the unique identification be carried out from October 1, 2020 onwards. The only identification of the work of assigning codes, unique identification of the registration system to submit and unique identification of the database to submit.
l? UDI is the "identity card" of medical device products, including product identification (UDI-DI) and production identification (UDI-PI), which is the basic and critical part of the UDI system implementation. In the current global UDI implementation process, the UDI of medical device products in the supply chain is often unreadable, so the firm, clear and readable UDI data carrier on the package or product is a very important link for manufacturers, and it is the key to realizing the effective implementation of UDI throughout the entire life cycle of medical devices.
Value:
When fully implemented, the Unique Device Identification System will provide a range of benefits to industry, the FDA, consumers, healthcare providers, and the healthcare system by:
l? Allowing for the more accurate reporting, review, and analysis of adverse event reports for faster identification and correction of problematic devices.
l? Reduces medical errors by enabling healthcare professionals and others to more quickly and accurately identify devices and obtain important information about device characteristics.
l? Enhances the analysis of devices on the market by providing a standardized and clear way to document device usage in electronic health records, clinical information systems, claims data sources, and registries. A more robust post-market surveillance system can also be utilized to support pre-market approval or licensing of new devices and new uses of currently marketed devices.
l? Provide standardized identifiers that enable manufacturers, distributors, and healthcare organizations to more effectively manage medical device recalls.
l? Lays the foundation for a global, secure distribution chain, helps address counterfeiting and diversion, and prepares for medical emergencies.
l? Leads the development of globally recognized medical device identification systems.
Content:
Key UDI Implementation Elements