Article 1 To strengthen the supervisory management of medical devices in the process of development, production, operation and use, improve the efficiency of supervisory management, establish a unique identification system for medical devices and innovate the supervisory management mode of medical devices, the Rules are formulated in accordance with relevant provisions of the Regulations on Supervisory Management of Medical Devices. Article 2 Medical devices sold or used within the territory of the People’s Republic of China shall conform to the requirements of these rules. Article 3 The unique identification system of medical device referred to in these rules consists of unified device identification, unique identification data carrier and unique identification database, jointly constructing the uniform identification system of medical devices. The unique identifier of a medical device refers to a code consisting of numbers, letters or symbols attached to a medical device product or package for unique identification of the medical device. —— 2 — Medical device unique identification data carrier refers to the data medium that stores or transmits the unique identifier of the medical device. The medical device unique identification database refers to a database that stores product identification and related information uniquely identified by the medical device. Article 4 The Rules refer to internationally-recognized standards. The Rules shall be guided by government principles, implemented by enterprises, and be implemented step-by-step. China National Medical Product Administration (NMPA) is responsible for establishing the unique identification system for medical devices, formulating and issuing the implementation plan of the unique identification system for medical devices. Article 5 The unique identification of medical devices in these rules refers to the alphanumeric code presented on the products or packages of medical devices, which is used for the unique identification of medical devices. Article 6 Unique identification of medical devices shall include product identification and production identification. Product identification is the unique code to identify the medical device registrant or filer as well as medical device model, specification and — 3 —— packaging; Production identification is the code to identify the data related to the production process of medical devices. According to the supervisory management and practical application requirements, the serial number, production batch number, production date and expiration date of medical devices can be included.
