Legal analysis: in order to implement the Notice of the General Office of the State Council on the Issuance of the Reform Plan for the Governance of High-Value Medical Consumables (Guo Ban Fa [2019] No. 37), to standardize the construction of the unique marking system for medical devices, and to strengthen the management of the entire lifecycle of medical devices, in accordance with the Regulations for the Supervision and Administration of Medical Devices, the State Food and Drug Administration (SDFA) formulated the Rules for Unique Marking System of Medical Devices, which shall be implemented as of 2019 October 1, 2019 shall come into force.
Legal basis: "Rules for Unique Identification System for Medical Devices"
Article 1 In order to standardize the construction of unique identification system for medical devices and strengthen the management of the whole life cycle of medical devices, these rules are formulated in accordance with the "Regulations for the Supervision and Administration of Medical Devices".
Article 2 The unique marking system of medical devices sold and used within the territory of the People's Republic of China shall comply with these rules.
Article 3 The medical device unique identification system referred to in these rules, by the medical device unique identification, unique identification data carrier and unique identification database.
Medical device unique identification, refers to the medical device products or packaging attached, composed of numbers, letters or symbols of the code, used to identify the uniqueness of medical devices.
Medical device unique identification data carrier means the data medium that stores or transmits the medical device unique identification.
Medical device unique identification database, refers to the storage of medical device unique identification of product identification and related information database.
Article 18 These rules shall come into force from October 1, 2019 onwards. The specific steps for the implementation of classification are separately formulated and published.