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On August 26, the State Food and Drug Administration issued the "Rules for the Unique Identification System of Medical Devices" (hereinafter referred to as the "Rules"), which aims to implement the "Notice of the General Office of the State Council on Printing and Distributing Reform Programs for High-Value Medical Consumables" [2019] No. 37) and the "Regulations on the Supervision and Management of Medical Devices" further strengthen the supervision and management of the entire life cycle of medical devices and innovate the supervision model. There are 18 rules in the Rules, which clarify the purpose, applicable objects, construction principles,responsibilities and relevant requirements of all parties for the construction of a unique identification system for medical devices.which will be officially implemented from October 1, 2019.

Interpretation of "Medical Device Unique Identification System Rules" by SFDA

What is the unique identification of medical devices?

The unique identification of a medical device consists of a product identification and a production identification. The product identification is a unique code that identifies the registrant / recorder, medical device model specifications, and packaging. It is a "keyword" that obtains medical device-related information from the database and is uniquely identified. Required part; production identification includes information related to the production process, including product batch number, serial number, production date and expiration date, etc, which can be used in conjunction with product identification to meet the needs of refined identification and recording of medical device circulation and use.

Unique identification has the principles of uniqueness, stability, and scalability. Uniqueness is the first principle, the basis for ensuring accurate product identification, and the core principle of the unique identification function. Due to the complexity of medical device products, the uniqueness should be consistent with the product identification requirements. For medical devices with the same characteristics, the uniqueness should point to a single specification product; for products controlled according to batch production, the uniqueness refers to the same batch of products. ; For medical devices that use serial number production control, uniqueness should point to a single product.

Stability means that once the unique identification is assigned to a medical device product, the product identification should remain unchanged as long as its basic characteristics have not changed. When a medical device is discontinued for sale or use. its product identification shall not be used for other medical devices; when it is resold or used, the original product identification may be used.

Scalability means that the unique identification should be compatible with the regulatory requirements and the continuous development of practical applications. The word "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 three levels of uniqueness of specifications, models, batches and individual products, so as to meet the current and future identification needs of medical devices.

2, Why build a unique identification system for medical devices?

Medical technology, medicine, and medical equipment are the three pillars of the medical service system. Medical equipment involves sound, light, electricity, magnetism, imaging, materials, mechanics and other industries and nearly a hundred professional disciplines. It is an internationally recognized high-tech industry. It has the characteristics of high-tech intensive, wide-ranging interdisciplinary, and technology integration and integration, which 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 endlessly, product diversity and complexity have continued to increase, and the phenomenon of no code or multiple codes in the circulation of medical devices is widespread, which has seriously affected the production, circulation, The precise identification of medical devices in various links such as use makes it difficult to achieve effective supervision and management.

Unique Device Identification (Unique Device Identification, UDI for short) is the identity card of a medical device. The medical device unique identification system consists of the unique identification of the medical device, the data carrier and the database. Each medical device is given an identity card, which realizes the transparency and visualization of production, operation and use, and improves the traceability of the product. It is an important starting point for the innovation of medical device supervision methods and the improvement of supervision efficiency. The bottom line and assisting the high-quality development of the medical device industry will play a positive role. Therefore, the construction of a unique identification system for medical devices in China is urgently needed.

唯一 Unique identification of medical devices is the focus and focus of international medical device regulation. In 2013, the International Medical Device Regulators Forum (IMDRF) released a guide to unique identification systems for medical devices. In the same year, the United States issued regulations for the unique identification system for medical devices, which required 7 years to fully implement the unique identification of medical devices. In 2017, EU legislation required the implementation of unique identification of medical devices, and Japan, Australia, Argentina and other countries have successively carried out related work. The worldwide unique identification of medical devices has continued to advance.

In 2012, the State Council issued the "Twelfth Five-Year Plan" National Drug Safety Plan, which called for "starting the national unified coding of high-risk medical devices". In 2016, the State Council issued the "Thirteenth Five-Year Plan" National Drug Safety Plan, which called for "constructing 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 called for "developing rules for the unique identification system of medical devices". In the "Reform Plan for Governing High-value Medical Consumables", it is explicitly proposed that "the rules for the unique identification system of medical devices". In July 2019, the State Food and Drug Administration and the National Health and Health Commission jointly issued the "Working Plan for Pilot Medical Device Unique Identification System", which kicked off the construction of a unique medical device identification system in China.

What is the significance of building a unique identification system for medical devices?

By establishing a unique identification system for medical devices, it is beneficial to achieve the integration and sharing of regulatory data, innovate regulatory models, improve regulatory effectiveness, strengthen the full life cycle management of medical devices, purify the market, optimize the business environment, and achieve a combination of government regulation and social governance In order to form a situation of social co-governance, it will help industrial transformation and upgrading and healthy development, provide the public with safer and more efficient medical services, and enhance the sense of gain of the people.

产业 From an industrial perspective, 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, improve corporate management efficiency, and promote high-quality development of the medical device industry. For medical device operating companies, the unique identification can be used to establish a modern logistics system that realizes the transparency, visualization, and intelligence of the medical device supply chain. For medical institutions, the use of unique identification will help reduce the use of mechanical errors, improve the level of consumables management in the hospital, and maintain patient safety.

政府 From the perspective of government management, for the supervision of medical devices, the use of unique identification can build big data for medical device supervision, so that the source of medical devices can be traced, traceable, responsibilities can be investigated, and smart supervision can be achieved. For the health administrative department, the use of unique identification can strengthen the standardized management of medical equipment, promote the establishment of big data in health care, improve the efficiency of health management, and help the health China strategy. For medical insurance departments, it helps to accurately identify medical devices in procurement tenders, promotes transparency in settlement, and combats fraud and abuse.

From a public perspective, through information disclosure and data sharing, consumers can rest assured to use and understand consumption, and effectively protect consumers' legitimate rights and interests.

24. What are the principles for the unique identification of medical devices?

The "Rules for Medical Device Unique Identification System" (hereinafter referred to as the "Rules") requires that the construction of unique identification systems should actively draw on international standards and follow the principles of government guidance, enterprise implementation, overall advancement, and distributed implementation. In order to better promote international exchanges and international trade, and optimize the business environment, the construction of the unique identification system in China has borrowed internationally accepted principles and standards. Establish a unique identification system, the government plays a guiding role, and the registrant / record holder is responsible for the implementation, and actively uses 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. Chinese medical devices are classified and managed according to their risk levels. Based on the practical experience of international unique identification, they are combined with China ’s medical device industry and regulatory practices. Compared with the United States and Europe, the implementation of the unique logo in China has increased the number of pilot links, mainly focusing on some high-risk implanted / interventional medical devices, with a smaller coverage and ensuring the steady progress of the rules.

5. How to realize the aggregation and sharing of unique identification data?

The convergence and sharing of medical device unique identification data is realized through the medical device unique identification database, which is organized by the State Drug Administration and uploaded by the registrant / recorder to the database of the uniquely identified product identification and related information in accordance with relevant standards and specifications. , And is 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.

26. Do products on the market need to be uniquely identified before the Rules come into effect?

起 From the date of implementation of the Rules, the registrant / recorder shall submit its product identification in the registration / recording management system when applying for registration, change of registration, or filing of relevant medical devices. Relevant medical device products shall be given a unique identification of the medical device during the production process, and the product identification and related data shall be uploaded before the product is marketed.

的 Medical devices that have been produced or sold before the implementation of the Rules may not have a unique identification for medical devices.

VII. How to choose the unique identification data carrier for medical devices?

Data carriers commonly used in the market today 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 mature for many years and has low cost. It can be compatible with existing code-scanning equipment on the market. However, one-dimensional codes occupy a large space and are damaged and corrected. poor ability.

A two-dimensional code is a bar code symbol that represents information in two dimensions. Compared to a one-dimensional code, it can hold more data in the same space. It can play a good role when the size of the device package is limited. Error-correcting ability, but the requirements on the reading equipment are higher than those of the one-dimensional code.

The radio frequency tag has information storage function, can receive the electromagnetic modulation signal of the reader and return the data carrier of the corresponding signal. The carrier cost of RFID tags and the cost of reading equipment are higher than those of one-dimensional and two-dimensional codes, but RFID reads fast and can be read in batches, which can play a role in certain links and fields.

The registrant / filer can select the appropriate medical device unique identification data carrier based on factors such as product characteristics, value, and main application scenarios.

VIII. What kind of qualifications do the code issuing organizations need, and what are their responsibilities and obligations?

码 The code issuing organization of the device's unique identification shall be a legal entity in China, with a sound management system and operating system, to ensure the uniqueness of the unique identification of the medical device created in accordance with its standards, and to comply with China's data security requirements.

The code issuing organization shall provide the registrant / recorder with the procedures for implementing its standard and guide the implementation. In order to facilitate the registrant / filer and others to grasp the coding standard of the code issuing agency for selection or application by relevant parties, the code issuing agency shall encode it The standard is uploaded to the database for unique identification of medical devices and maintained dynamically. Before January 31 of each year, the code issuing agency shall submit to the State Drug Administration a report on the previous year of the unique identification created in accordance with its standards.

IX. What is the procedure for the registrant / filer to implement the unique identification?

The registrant / filer's implementation of the unique identification process is:

Step 1: The registrant / filer chooses the issuing agency in accordance with the Rules and relevant standards and the actual situation of the enterprise.

Step 2: The registrant / filer creates the product identification according to the standards of the code issuing organization, and determines the composition of the product production identification.

Step 3: From the date of implementation of the Rules, when applying for medical device registration, registration change, or filing, the registrant / recorder shall submit the product identification in the registration / recording management system.

Step 4: The registrant / filer selects an appropriate data carrier according to the standards of the code issuing organization, and assigns a 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 updates the database of the unique identification of the medical device in a timely manner.

Medical Device Unique Identification System Rules

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

Article 2 The unique identification system of medical devices sold and used in the People's Republic of China shall comply with these rules.

Article 3 The unique identification system for medical devices referred to in these rules consists of the unique identification of the medical device, the unique identification data carrier, and the unique identification database.

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

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

The medical device unique identification database refers to a database storing product identification and related information of the medical device unique identification.

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

Article 5 The State Drug Administration is responsible for establishing a unique identification system for medical devices, formulating plans for the construction of a unique identification system for medical devices, promoting the active use of unique identifications for medical devices, and promoting the full life-cycle management of medical devices.

Provincial, autonomous region and municipality drug regulatory departments are responsible for guiding and supervising registrants / record holders in their respective administrative areas to carry out work related to the construction of medical device unique identification systems.

Article 6 The registrant / filer is responsible for creating and maintaining the unique identification of the medical device in accordance with this rule, giving the medical device unique identification data carrier on the product or packaging, uploading relevant data, and using the unique identification of the medical device to strengthen the entire process management of the product.

Encourage medical device production and operation enterprises 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. Product identification is the unique code that identifies the registrant / filer, medical device model specifications and packaging; the production identification consists of codes related to the medical device manufacturing process information, and can include the serial number of the medical device, the production batch number, Production date, expiration date, etc.

When a product changes that may affect medical device identification, traceability or regulatory requirements, a new product identification should be created.

If the sales and use of medical devices are stopped, their product identification shall not be used for other medical devices; when they are resold or used, the original product identification may be used.

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

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

Stability refers to 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 remain unchanged, the product identification should remain unchanged.

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

Article 9 The registrant / filer shall create and maintain a unique identifier for a medical device in accordance with the standards for the preparation of a unique identifier for a medical device.

The standard for the unique identification of medical devices shall comply with the relevant standards formulated by the State Drug Administration and the code issuing agency that meets the requirements of this rule.

Article 10 The code issuing institution shall be a legal person institution in China, with a complete management system and operating system, to ensure the uniqueness of the unique identification of the medical device created in accordance with its standards, and to comply with relevant national data security requirements.

The code issuing agency shall provide the registrant / filer with the process of implementing its standards and guide the implementation. It shall upload its coding standards to the database of unique identification of medical devices and maintain them dynamically. The standard creates a report that uniquely identifies the previous year.

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

Article 11 The data carrier for the unique identification of a medical device shall meet the requirements of automatic identification and data acquisition technology and manual reading. If space is limited or use is limited, a carrier form that conforms to 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. Encourage the use of advanced automatic identification and data collection technologies.

When using one-dimensional code, the product identification and production identification can be connected in series or in multiple lines. When using RFID tags, one-dimensional or two-dimensional codes should be provided at the same time.

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

Article 13 The State Drug Administration shall formulate relevant standards and specifications for the unique identification data of medical devices, and organize the establishment of a database for unique identification of medical devices for public inquiry.

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 shall be responsible for the authenticity, accuracy and completeness of the data.

Article 15 The registrant / filer shall submit his product identification in the registration / file 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 supervision and administration department may call and manage relevant data according to regulatory requirements.

Relevant parties are encouraged to adopt advanced information technology and apply the unique identification of medical devices to manage medical devices in the aspects of production, operation and use.

Article 17 The meaning of the following terms in these rules:

Automatic identification and data collection refers to the technology of directly entering data into a computer system or other microprocessor-controlled equipment without using a keyboard.

Manual reading refers to the coded information corresponding to the machine reading medium and directly recognizable by human eyes.

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

Jiangsu Medical Equipment Circle Comment: The implementation of the unique identification of medical devices has become the strictest policy in history, which will affect the entire process of production, sales, use, and traceability of medical devices. Generally speaking, each product can only have a batch number before, and now it must have a unique serial number. A serial number label can only be used on a patient. In the past, the hospital did not require it, and it did not use the system to query the platform. The distributors could attach the labels as they wished, and some distributors even provided their own labeling machines. In the future, all data production companies submit to the SFDA system for record, which distributors of this batch of products with this serial number are sold to, and which hospitals and patients are sold at a glance. From now on, one-to-one correspondence is required, from the source of production to the whole process of supervision. There are a large number of dealers who have mixed fish and fish, and soon prototypes appear. Those manufacturers with incomplete bidding product specifications will also be affected one after another, and can be labelled before, which will be very dangerous in the future. It used to be profitable, but now it needs legal compliance!