Medical devices implement the unique identification/UDI regulatory system. After a long period of public discussion and soliciting opinions, it was officially announced at a special meeting organized by the State Drug Administration on August 27. UDI rules will come into effect on October 1, 2019。

In order to implement the "Notice of the General Office of the State Council on Printing and Distributing the Reform Plan for the Governance of High-value Medical Consumables" (Guobanfa [2019] No. 37), standardize the construction of the unique identification system for medical devices, and strengthen the management of the entire life cycle of medical devices, in accordance with the "Medical Devices Supervision and Administration Regulations, the State Food and Drug Administration has formulated the "Medical Device Unique Identification System Rules", which are hereby promulgated and shall come into force on October 1, 2019.
  Special announcement.

　　Attachment: Rules for the Unique Identification System of Medical Devices

State Drug Administration
August 23, 2019

Attachment: Rules for the Unique Identification System of Medical Devices

Article 1 In order to standardize the construction of a unique identification system for medical devices and strengthen the management of the entire life cycle of medical devices, these rules are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2 The unique identification system for 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 is composed of a medical device unique identification, a unique identification data carrier and a unique identification database.

The unique identification of a medical device refers to a code composed of numbers, letters or symbols attached to the product or packaging of a medical device and used to uniquely identify the medical device.

The data carrier for the unique identification of a medical device refers to a data medium that stores or transmits the unique identification of a medical device.

The medical device unique identification database refers to the database that stores the product identification and related information of the medical device unique identification.

Article 4 The construction of the unique identification system for medical devices shall actively learn from international standards and follow the principles of government guidance, enterprise implementation, overall planning and step-by-step implementation.

Article 5 The National Medical Products Administration is responsible for establishing a medical device unique identification system system, formulating a medical device unique identification system construction plan, promoting all parties to actively apply medical device unique identification, and promoting medical device life-cycle management.

The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for guiding and supervising registrants/filers in their respective administrative regions to carry out work related to the construction of a unique identification system for medical devices.

Article 6 The registrant/filer is responsible for creating and maintaining the unique identification of medical devices in accordance with these rules, assigning data carriers for the unique identification of medical devices on products or packaging, uploading relevant data, and using the unique identification of medical devices to strengthen the entire product process management.

Encourage medical device manufacturers and users to actively apply the unique identification of medical devices for related management.

Article 7 The unique identification of medical devices includes product identification and production identification. The product identification is a unique code that identifies the registrant/filer, the model specification and packaging of the medical device; the production identification is composed of the code of the relevant information of the medical device production process, and can include the serial number of the medical device, the production batch number, and the Production date, expiration date, etc.

When a product changes that may affect the identification and traceability of medical devices or changes in regulatory requirements, a new product label shall be created.

If the sale or use of a medical device is stopped, the product label shall not be used for other medical devices; when it is resold or used, the original product label can be used.

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

Uniqueness means that the unique identification of a medical device should be consistent with the medical device identification requirements.

Stability means that the unique identification of a medical device should be related to the basic characteristics of the product. If the basic characteristics of the product have not changed, the product identification should remain unchanged.

Scalability means that the unique identification of medical devices should be adapted to the continuous development of regulatory requirements and practical applications.

Article 9 The registrant/filer shall create and maintain the unique identification of medical devices in accordance with the compilation standards for the unique identification of medical devices.

The standards for the preparation of the unique identification of medical devices shall comply with the relevant standards established by the State Drug Administration and the code issuing agencies that meet the requirements of this rule.

Article 10 The code-issuing agency shall be a legal entity in China with a complete management system and operation system to ensure the uniqueness of the unique identification of medical devices created in accordance with its standards and meet the relevant national data security requirements.

The code issuing agency shall provide the registrant/filer with the process of implementing its standard and guide its implementation, and the coding standard shall be uploaded to the medical device unique identification database and maintained dynamically. It shall be submitted to the State Drug Administration before January 31 of each year in accordance with its standards. A report created by the standard that uniquely identifies the previous year.

The state encourages code issuing agencies to adopt relevant international standards to establish a unique identification operation system.

Article 11 The data carrier for the unique identification of medical devices shall meet the requirements of automatic identification and data collection technology as well as manual reading. If the space is limited or the use is limited, the carrier format that conforms to the automatic identification and data collection technology should be preferred.

Automatic identification and data collection technologies include one-dimensional codes, two-dimensional codes, or radio frequency tags. Advanced automatic identification and data collection technologies are encouraged.

When using a one-dimensional code, the product identification and production identification can be connected in series, or multiple lines can be connected in parallel; when using a radio frequency tag, a one-dimensional code or a two-dimensional code should be provided at the same time.

Article 12 The registrant/filer shall select the data carrier standard that is compatible with the unique identification of the medical device created by it, and assign the unique identification to the minimum sales unit of the medical device and higher-level packaging or medical device products listed in its name Data carrier, and ensure that the unique identification data carrier is firm, clear and readable during the operation and use of medical devices.

Article 13 The National Medical Products Administration shall formulate relevant standards and norms for the data of unique identification of medical devices, and organize the establishment of a database of unique identification of medical devices for public inquiries.

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

Article 15 The registrant/recorder shall submit its product identification in the registration/record management system when applying for medical device registration, registration change or filing.

The registrant/filer shall upload the product identification and related data to the medical device unique identification database before the product goes on sale.

Article 16 The drug regulatory authority may call and manage relevant data according to regulatory requirements.

Encourage all relevant parties to adopt advanced information technology and apply unique identification of medical devices to manage the production, operation, and use of medical devices.

Article 17 The meaning 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 equipment without using a keyboard.

Manual reading refers to the coded information that corresponds to the machine reading medium and can be directly recognized by the human eye.

Article 18 These rules shall come into effect on October 1, 2019. The specific steps for classification implementation will be formulated and announced separately.

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Interpretation of "Medical Device Unique Identification System Rules"

1. What is the unique identification of a medical device?

The unique identification of a medical device is composed of a product identification and a production identification. The product identification is a unique code to identify the registrant/filer, the model specification and packaging of the medical device. It is the "keyword" for obtaining medical device-related information from the database and is the unique identification Required part: The production identification includes information related to the production process, including product batch number, serial number, production date and expiration date, etc., and can be used in conjunction with the product identification to meet the needs of fine identification and recording of medical device circulation and use.
　　The unique identification has the principle of uniqueness, stability and scalability. Uniqueness is the primary principle, the basis for ensuring accurate product identification, and the core principle for unique identification to function. Due to the complexity of medical device products, uniqueness should be consistent with the product identification requirements. For medical devices with the same characteristics, uniqueness should point to a single specification and model product; for products controlled by batch production, uniqueness should point to the same batch of products ; For medical devices that use serial number production control, the uniqueness should point to a single product.
　　Stability means that once a unique identifier is assigned to a medical device product, as long as its basic characteristics have not changed, the product identifier should remain unchanged. When the sale or use of a medical device is stopped, its product label shall not be used for other medical devices; when it is resold or used, the original product label can be used.
Scalability means that the unique identification should be adapted to the continuous development of regulatory requirements and practical applications. The term "unique" does not mean serial number management of a single product. In the unique identification, the production identification can be used in conjunction with the product identification , To achieve the uniqueness of the three levels of specifications, models, batches and individual products, so as to meet the current and future needs for medical device identification.

　　 2. Why build a unique identification system for medical devices?
Medical technology, medicines, and medical devices are the three pillars of the medical service system. Medical devices involve industries such as sound, light, electricity, magnetism, imaging, materials, mechanics, etc. and nearly 100 professional disciplines. They are internationally recognized high-tech industries. It has the characteristics of high-tech intensive, extensive interdisciplinarity, and technology integration and integration, and represents the comprehensive strength of a country's high-tech. In recent years, the medical device industry has developed rapidly. New technologies and new products have emerged one after another. Product diversity and complexity have continued to increase. The phenomenon of uncoded or multiple codes in the circulation and use of medical devices is common, which has seriously affected the production, circulation, and distribution of medical devices. Accurate identification of medical devices in various links such as use is difficult to achieve effective supervision and management.
　　Unique Device Identification (UDI) is the ID card of medical devices. The unique identification system of medical devices consists of the unique identification of medical devices, data carrier and database. Assigning an ID card to each medical device to achieve transparency and visualization of production, operation, and use, and improve product traceability, is an important starting point for the innovation of medical device supervision methods and the improvement of supervision efficiency. It is important to strictly observe the safety of medical devices. The bottom line and boosting the high-quality development of the medical device industry will all play a positive role. Therefore, the construction of a unique identification system for medical devices in my country is urgently needed.
　　 The unique identification of medical devices is the focus and hot spot in the field of international medical device supervision. In 2013, the International Medical Device Regulatory Forum (IMDRF) issued guidelines for the unique identification system of medical devices. In the same year, the United States issued regulations on the unique identification system for medical devices, requiring 7 years to fully implement the unique identification of medical devices. In 2017, EU legislation required the implementation of the unique identification of medical devices, and countries such as Japan, Australia, and Argentina have also carried out related work, and the global unique identification of medical devices has continued to advance.
　　 In 2012, the State Council issued the "Twelfth Five-Year" National Drug Safety Plan, which required "initiate the national uniform coding of high-risk medical devices." In 2016, the State Council issued the "Thirteenth Five-Year" National Drug Safety Plan, which required "building a medical device coding system and formulating medical device coding rules." In 2019, the General Office of the State Council issued the “Key Tasks for Deepening the Reform of the Medical and Health System in 2019”, which required “to formulate rules for the unique identification system for medical devices”, which was reviewed and approved at the eighth meeting of the Central Comprehensive Reform Commission and issued by the General Office of the State Council. In the "Reform Plan for Governance of High-Value Medical Consumables", it is clearly proposed that "rules for a unique identification system for medical devices" are formulated. In July 2019, the State Food and Drug Administration and the National Health Commission jointly issued the "Pilot Work Plan for the Unique Identification System for Medical Devices", which kicked off the construction of the unique identification system for medical devices in my country.

　　 3. What is the significance of building a unique identification system for medical devices? The establishment of a unique identification system for medical devices is conducive to the integration and sharing of regulatory data, innovating regulatory models, improving regulatory efficiency, strengthening medical device life-cycle management, purifying the market, optimizing the business environment, and realizing the integration of government supervision and social governance , To form a situation of social co-governance, promote industrial transformation and upgrading and healthy development, provide the public with safer and more efficient medical services, and enhance the people’s sense of gain.
　　From an industrial point of view, for medical device manufacturers, the use of unique identification can help improve the level of enterprise information management, establish a product traceability system, strengthen industry self-discipline, enhance corporate management efficiency, and promote the high-quality development of the medical device industry. For medical device operating companies, the use of unique identification can establish a modern logistics system and realize the transparency, visualization and intelligence of the medical device supply chain. For medical institutions, the use of unique identifiers will help reduce errors in the use of equipment, improve the management of consumables in the hospital, and maintain patient safety.
　　From the perspective of government management, for medical device supervision, the use of unique identifiers can build medical device supervision big data, realize the source of medical devices can be traced, whereabouts can be traced, responsibility can be investigated, and smart supervision can be realized. For health administrative departments, the use of unique identifiers can strengthen the standardized management of medical device use, promote the establishment of health care big data, improve health management efficiency, and help the healthy China strategy. For the medical insurance department, it is helpful to accurately identify medical devices in procurement bidding, promote the realization of settlement transparency, and combat fraud and abuse.
　　From a public perspective, through information disclosure and data sharing, consumers can use it with confidence and understand consumption, and effectively protect their legitimate rights and interests.

　　 4. What principles does the implementation of the unique identification of medical devices follow?　　 The "Medical Device Unique Identification System Rules" (hereinafter referred to as the "Rules") require that the construction of the unique identification system should actively learn from international standards and follow the principles of government guidance, enterprise implementation, overall promotion, and distributed implementation. In order to better promote international exchanges and international trade, and optimize the business environment, the construction of my country's unique identification system draws on international principles and standards. Establish a unique identification system, the government plays a guiding role, the registrant/recorder is responsible for implementation as the first responsible person, and actively apply the unique identification to improve product quality and corporate management. Due to the diversity and complexity of medical devices, the step-by-step implementation of unique identification is an internationally accepted practice. my country's medical devices are classified according to risk levels. Based on the practical experience of international unique identification, combined with my country's medical device industry and regulatory practices , Formulated a step-by-step implementation policy. Compared with the United States and Europe, my country’s implementation of unique identification has increased pilot links, focusing on some high-risk implant/interventional medical devices, with a smaller coverage area, and ensuring the steady progress of the rules.

　　 5. How to achieve unique identification data aggregation and sharing? The collection and sharing of medical device unique identification data is realized through the medical device unique identification database, which is organized and constructed by the National Medical Products Administration, and the registrant/filer uploads the uniquely identified product identification and related information to the database in accordance with relevant standards and specifications , And responsible for the accuracy and uniqueness of the data. Medical device operating companies, medical institutions, relevant government departments and the public can share unique identification data through data query, download, and data docking.

　　6. ​​Do products that have been on the market before the implementation of the "Rules" need to be uniquely identified?　　 From the date of implementation of the "Rules", the registrant/filer shall submit its product identification in the registration/filing management system when applying for relevant medical device registration, registration change or filing. The relevant medical device products shall be given a unique identification of the medical device during the production process, and the unique identification of the medical device shall be uploaded and the relevant data shall be completed before the product goes on sale.
　　 Medical devices that have been manufactured and sold before the implementation of the "Rules" may not have the unique identification of medical devices.

7. How to choose a data carrier for unique identification of medical devices?　　 The commonly used data carriers currently on the market include one-dimensional codes, two-dimensional codes and radio frequency tags (RFID).
One-dimensional code is a bar code symbol that only represents information in one-dimensional direction. It has been used for many years and has been very mature, low cost, and can be well compatible with existing code scanning equipment on the market, but one-dimensional code occupies a large space and is damaged and corrected. poor ability.
A two-dimensional code is a barcode symbol that represents information in a two-dimensional direction. Compared with a one-dimensional code, the same space can accommodate more data. It can play a good role when the size of the device packaging is limited. Error correction capability, but the requirements for reading equipment are higher than that of one-dimensional codes.
　　 The radio frequency tag has the function of information storage, can receive the electromagnetic modulation signal of the reader, and return the data carrier of the corresponding signal. The carrier cost and reading equipment cost of RFID tags are higher than that of one-dimensional codes and two-dimensional codes. However, RFID has a fast reading speed and can be read in batches, which can play a role in certain links and fields.
　　 The registrant/filer can choose the appropriate medical device unique identification data carrier according to the product characteristics, value, main application scenarios and other factors.

　　 8. What qualifications does the code issuing agency have, and what are its responsibilities and obligations?　　 The code issuing agency for the unique device identification shall be a legal entity within China, with a complete management system and operation system, to ensure the uniqueness of the unique identification of medical devices created in accordance with its standards, and to comply with my country's data security requirements.
The code issuing agency shall provide the registrant/filer with the process of implementing its standards and guide the implementation. In order to facilitate the registrant/filer to grasp the coding standards of the code issuing agency for selection or application by related parties, the code issuing agency shall code it The standards are uploaded to the medical device unique identification database and maintained dynamically. Before January 31 of each year, the code issuing agency shall submit to the State Drug Administration a report that uniquely identifies the previous year created in accordance with its standards.

　　 9. What is the procedure for the registrant/filer to implement unique identification?　　 The process for the registrant/filer to implement unique identification is:
　　The first step: the registrant/filer selects the code issuing agency in accordance with the "Rules" and related standards, combined with the actual situation of the enterprise.
　　 Step 2: The registrant/filer creates a product logo in accordance with the standards of the code issuing agency and determines the composition of the product production logo.
　　 Step 3: From the date of implementation of the "Rules", if applying for medical device registration, registration change, or filing, the registrant/filer shall submit the product identification in the registration/file management system.
　　 Step 4: The registrant/filer selects an appropriate data carrier according to the standards of the code issuing agency, and assigns the medical device unique identification data carrier to the smallest sales unit of medical devices and higher-level packaging or medical device products.
　　 Step 5: The registrant/filer uploads the product identification and related information to the medical device unique identification database before the product goes on sale.
　　 Step 6: When the product identification and data related information changes, the registrant/filer shall update the medical device unique identification database in a timely manner.