关键词: font-size:medium, ">医疗器械唯一标识（UDI）；合规实施方法；生产企业

Abstract: Unique device identifier (UDI) is the “ID card” of medical devices. Strengthening the whole life cycle management of medical devices and standardizing the construction of the UDI system can not only improve the management level of medical devices， but also effectively ensure the safety of medical devices for the public. Manufacturers are the main body of UDI implementation and the source of UDI implementation. Taking effective measures to ensure that the unique identification of medical devices is firm， clear and readable during the operation and use of medical devices is the basic guarantee for the implementation of UDI system and the comprehensive application and operation of UDI in the industry. This paper reviewed the relevant laws, regulations and standards of the UDI system in China， analyzed the policies on UDI and the promotion trends of UDI. The implementation of UDI in the first and second batch of pilot enterprises was summarized. The implementation methods of UDI in manufacturing enterprises were summarized， covering the implementation procedure， basic preparation， key tasks and weight， including code allocation， data submission， labels with markings， and so on. Through comparing the implementation methods of UDI under different application scenarios， the reference time plan for the implementation of UDI was formulated， and some issues that enterprises need to pay attention to when implementing UDI were pointed out. This paper provides reference for the manufacturing enterprises to effectively implement UDI and meet the regulation requirements.

Key words: Unique device identifier (UDI), Regulation compliance implementation, Manufacturing enterprises