The National Medical Products Administration (NMPA) has released the rules for the medical device unique identification system, which will come into effect on October 1.

According to the website of the National Medical Products Administration (NMPA), in order to implement the "Notice of the General Office of the State Council on Issuing the Reform Plan for the Governance of High-Value Medical Consumables" (Guobanfa [2019] No.), standardize the construction of the medical device unique identification system, strengthen the management of the entire life cycle of medical devices, and in accordance with the "Regulations on the Supervision and Administration of Medical Devices," the NMPA has formulated the "Rules for the Medical Device Unique Identification System," which is hereby issued and shall come into effect on37the2019year10month1day.

Rules for the Medical Device Unique Identification System

Article 1 These Rules are formulated to standardize the construction of the medical device unique identification system, strengthen the management of the entire life cycle of medical devices, and in accordance with the "Regulations on the Supervision and Administration of Medical Devices."

Article 2 Medical devices sold and used within the People's Republic of China shall comply with these Rules in their unique identification system.

Article 3 As used in these Rules, the medical device unique identification system consists of a medical device unique identifier, a unique identifier data carrier, and a unique identifier database.

The medical device unique identifier is a code consisting of numbers, letters, or symbols affixed to the medical device product or packaging, used for the unique identification of medical devices.

The medical device unique identifier data carrier is the data medium that stores or transmits the medical device unique identifier.

The medical device unique identifier database is the database that stores the product identification and related information of the medical device unique identifier.

Article 4 The construction of the medical device unique identification system should actively draw on international standards and follow the principles of government guidance, enterprise implementation, coordinated promotion, and phased implementation.

Article 5 The National Medical Products Administration is responsible for establishing the medical device unique identification system, formulating the construction plan for the medical device unique identification system, promoting the active application of medical device unique identification, and promoting the management of the entire life cycle of medical devices.

Provincial, autonomous region, and municipality directly under the Central Government drug supervision and administration departments are responsible for guiding and supervising the registrants/and filers in their respective administrative regions to carry out relevant work on the construction of the medical device unique identification system.

Article 6 Registrants/and filers are responsible for creating and maintaining medical device unique identifiers in accordance with these Rules, assigning medical device unique identifier data carriers to products or packaging, uploading relevant data, and using medical device unique identifiers to strengthen product lifecycle management.

Medical device manufacturers, distributors, and users are encouraged to actively apply medical device unique identifiers for relevant management.

Article 7 The medical device unique identifier includes a product identifier and a production identifier. The product identifier is a unique code that identifies the registrant/filer, medical device Model and Specification, and packaging; the production identifier consists of codes of information related to the medical device production process and, based on regulatory and practical application needs, may include the medical device serial number, production batch number, production date, and expiration date.

When changes occur that may affect the identification or traceability of the medical device, or when regulatory requirements change, a new product identifier should be created.

When a medical device is discontinued, its product identifier may not be used for other medical devices; when it is resold or reused, the original product identifier may be used.

Article 8 The medical device unique identifier shall meet the requirements of uniqueness, stability, and scalability.

Uniqueness means that the medical device unique identifier shall be consistent with the medical device identification requirements.

Stability means that the medical device unique identifier shall be related to the basic characteristics of the product, and the product identifier shall remain unchanged if the basic characteristics of the product do not change.

Scalability means that the medical device unique identifier shall adapt to the continuous development of regulatory requirements and practical applications.

Article 9 Registrants/Filers shall create and maintain medical device unique identifiers in accordance with the compilation standards for medical device unique identifiers.

The compilation standards for medical device unique identifiers shall comply with the relevant standards formulated by the National Medical Products Administration and coding agencies that meet the requirements of these Rules.

Article 10 Coding agencies shall be legal entities within China, with sound management systems and operational systems to ensure the uniqueness of medical device unique identifiers created according to their standards, and comply with national data security requirements.

Coding agencies shall provide registrants/and filers with the processes for implementing their standards and provide guidance on implementation. They shall upload their coding standards to the medical device unique identifier database and dynamically maintain them, and submit an annual report on the unique identifiers created according to their standards to the National Medical Products Administration before1month31day of each year.

The state encourages coding agencies to adopt relevant international standards to establish a unique identification operating system.

Article 11 The medical device unique identifier data carrier shall meet the requirements of automatic identification and data acquisition technology and manual reading. If space is limited or use is restricted, data carriers that comply with automatic identification and data acquisition technology should be prioritized.

Automatic identification and data acquisition technologies include one-dimensional codes, two-dimensional codes, or radio frequency tags, and the use of advanced automatic identification and data acquisition technologies is encouraged.

When using one-dimensional codes, the product identifier and production identifier can be concatenated or paralleled in multiple lines; when using radio frequency tags, one-dimensional or two-dimensional codes should be included.

Article 12 Registrants/Filers shall select data carrier standards that are compatible with the medical device unique identifiers they create, assign unique identifier data carriers to the minimum sales units and higher-level packaging or medical device products listed in their name, and ensure that the unique identifier data carriers are firm, clear, and readable during the operation and use of the medical devices.

Article 13 The National Medical Products Administration shall formulate standards and specifications for medical device unique identifier data, and organize the establishment of a medical device unique identifier database for public inquiry.

Article 14 Registrants/The registrant shall upload, maintain, and update the relevant data in the unique identifier database in accordance with relevant standards or specifications, and shall be responsible for the authenticity, accuracy, and completeness of the data.

Article 15 Registrants/When applying for medical device registration, registration changes, or handling filing, the registrant shall/submit its product identification in the registration and filing management system.

Registrants/Before the product is put on the market, the registrant shall upload the product identification and relevant data to the medical device unique identifier database.

Article 16 The drug supervision and administration department may access and manage relevant data according to regulatory needs.

All relevant parties are encouraged to adopt advanced information technology and apply the unique identifier of medical devices to manage medical devices in the production, operation, and use stages.

Article 17 The meanings of the following terms in these Rules:

Automatic identification and data acquisition refers to the technology of directly inputting data into a computer system or other microprocessor-controlled device without using a keyboard.

Manual reading refers to the encoding information that can be directly identified by the human eye, corresponding to the machine-readable medium.

Article 18 These Rules shall come into force on2019year10month1The specific steps for phased implementation shall be formulated and announced separately.