Medical Device Identification System Rules

Pharmaceutical Network February 28 hearing for the implementation of the CPC Central Committee and General Office of the State Council, "on deepening the reform review and approval system reform and encourage the innovation of medical devices," and "Regulations on the Supervision and Administration of Medical Devices" to strengthen the development of medical devices, production, Operation and use of the whole process of supervision and management, the State Food and Drug Administration organized the development of "medical device unique identification system rules (draft)" and its preparation instructions (see annex), is open for comment.

Please send comments of modification to the Medical Device Registration Department of the State Food and Drug Administration before April 30, 2018 by email.

E-mail: mdct@cfda.gov.cn

Tel: 010-88331463

Annex: 1. Medical Devices Unique Identification System Rules (Exposure Draft)

2. "Medical Devices Unique Identification System Rules (Draft)" instructions

General Office of Food and Drug Administration

February 26, 2018

Article 1 The purpose of the legislation is to strengthen the supervision and management of the development, production, operation and use of medical devices to improve the efficiency of supervision and management, to establish the unique identification system of medical devices and to innovate the supervision mode of medical devices. According to the Regulation on the Supervision and Administration of Medical Devices, Relevant regulations, the enactment of these rules.

Article 2 The medical devices sold or used by the 'applicable object' in the territory of the People's Republic of China shall meet the requirements of these Rules.

Article 3 "Unique Identification System Definition" The "unique identification system of medical devices" as mentioned in these rules refers to the unified identification system of medical devices which is composed of the medical device unique identification, unique identification data carrier and unique identification database.

Article 4 'Responsibilities' The State Food and Drug Administration is responsible for establishing the system of unique identification of medical devices and formulating the implementation plan for issuing the unique identification system of medical devices.

Article 5 'Unique Identification Definition' The unique identification of medical devices as mentioned in these rules refers to an alphanumeric code presented on a medical device product or package for the unique identification of medical devices.

Article 6 The unique identification of a medical device shall include the product identification and the production identification.The product identification is the unique code for identifying the registered or registered medical device, the type specification of the medical device and the package code, and the production identification is the identification of the manufacturing process of the medical device Relevant data code, according to regulatory and practical requirements may include medical device serial number, production lot number, production date, expiration date and so on.

If the product may affect the identification of medical devices, traceability or regulatory requirements change, should create a new product logo.

When medical devices stop selling and using, their product identification shall not be used for other medical devices; when re-selling and using, the original product identification may be used.

Article 7 'The Only Principle of Unique Identification' The unique identification of medical devices should conform to the principle of uniqueness, stability and scalability.

Uniqueness: The unique identification of the medical device should be consistent with the identification requirements of the medical device.

Stability: The unique identifier of the medical device should be related to the basic characteristics of the product. If the basic characteristics of the product have not changed, the product identifier should remain unchanged.

Extensibility: The unique identification of medical devices should be compatible with the regulatory requirements and the continuous development of practical applications.

Article 8 'Requirement for Creating a Unique Label' The holder or the record maker of a medical device shall create and maintain the unique identifier of the medical device in accordance with the standard for the unique label of the medical device, which may include the approval of the State Food and Drug Administration Code agencies or the State Food and Drug Administration to develop the relevant standards.

Article 9 'Unique Identification Data Carrier Definition' The unique identification data carrier of a medical device is a data medium for storing and / or transmitting the unique identifier of a medical device.

Article 10 "Uniquely Identifiable Data Carrier Form" The medical device uniquely identified data carrier may adopt one-dimensional code, two-dimensional code or radio frequency tag, etc. The advanced data carrier technology is encouraged.

When using a one-dimensional code, the product identification and production identification can be connected in series or multiple lines 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 11 'Uniquely Identifiable Data Carrier Requirements' The unique identification data carrier of a medical device shall meet the requirements of automatic identification and data acquisition technology and manual reading, and if the space is limited or the use is limited, it is in principle preferred to use the automatic identification and data Acquisition technology carrier form.

Article 12 'The standard for the data carrier that gives the unique identification data carrier' shall be chosen by the holder or the record holder of the medical device for registration of the medical device, or the packaging of the sales unit at all levels of the medical device on its name Assign unique identification data carriers to medical device products and ensure that the unique identifier data carrier is strong, legible and readable during the operation and use of the medical device.

Article XIII 'unique identification database definition' medical device unique identification database contains the medical device product identification and related data.

The State Food and Drug Administration formulated the relevant standards and norms for unique identification data of medical devices and organized the establishment of a unique identification database of medical devices for public inquiries.

Article 14 The principal or the registered medical device registered person or the record holder shall upload, maintain and update the relevant data in the unique identification database according to relevant standards or regulations, and be responsible for the authenticity and accuracy of the data.

Article 15 'Submitting Requirements for Uniquely Identifiable Data' The registrant or the record holder shall provide the product identification of the declared product in the registration / filing management system when applying for medical device registration or filing.

The registered person or the record holder shall upload the product mark and related data to the medical device unique identification database within 30 working days after the registration of the product is approved, the record is made or the change is made.

Article XVI 'unique use of the logo' Food and Drug Administration may be called according to regulatory requirements and management of relevant data.

Encourage the production and operation of medical devices and the application of the unique identification of medical devices by the operating units and units for product-related management.

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

A one-dimensional code is a barcode symbol that represents information in a one-dimensional direction.

A two-dimensional code is a bar code symbol that represents information in two dimensions.

RF tag is used for identification of objects or objects, with information storage capabilities, can receive the reader electromagnetic modulation signal, and return the corresponding signal data carrier.

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

Artificial reading refers to the text information associated with the machine-readable medium, which is directly recognized by the human eye.

Article 18 'The Implementation Date' These Rules shall come into force on XX XX of 2018.

In order to implement the "Regulations on the Supervision and Administration of Medical Devices" (the "Regulations") of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Innovation of Examination and Approval System Reform, Encourage the Innovation of Medical Devices, and strengthening the research, production and operation of medical devices And use the whole process of supervision and management to improve the effectiveness of supervision and management, the establishment of a unique identification of medical devices, innovative regulatory model, in accordance with the overall arrangements for the coding of medical devices, the General Administration formulated the "Medical Devices Identification System Rules."

Unique Device Identification (UDI) is an electronic identification card for medical device products. The unique identification data carrier is a medium for storing or transmitting electronic identification cards. The unique identification database is a database for storing medical device unique identifiers and related information , The three together form a unique identification system for medical devices.It is conducive to the rapid and accurate identification of medical devices in the development, production, operation and use of information technology through the establishment of a unique identification system for medical devices, which is conducive to product regulation Data sharing and integration are conducive to innovative regulatory model, improve regulatory effectiveness, and strengthen the life-cycle management of medical devices.

The unique identification of medical devices is the focus of attention in today's international medical device regulatory field.In 2013, the International Medical Device Regulatory Agency Forum (IMDRF) and the United States FDA respectively released the relevant guidelines on the unique identification system of medical devices and Regulations , The United States FDA took the lead in implementing the unique identification of medical devices for the third type of medical devices in 2014. In May 2017, the EU promulgated the medical device regulations to clarify the regulatory requirements for implementing the unique identification of medical devices. Japan, Australia and other countries also started to carry out related Work, the global unique identification of medical devices continue to advance.

In 2006, the regulatory authorities in Shanghai conducted some retrospective pilot projects on coding of implantable medical devices, and in 2012, the State Council printed and issued the 'National 12th Five-Year Plan for National Drug Safety' and demanded that the government should start the national unified coding of high-risk medical devices. In 2014, the "Regulations" were revised and promulgated, while Article 32 requires the state to encourage the use of advanced technology to record the sales and use of medical devices. In 2016, the State Council issued the "13th National Drug Safety Plan" Medical equipment coding system, the development of medical equipment coding rules'. China's medical equipment unique identification system construction is urgently needed.

The SAIC attaches great importance to the work related to the unique identification of medical devices. In 2013, it commissioned the EPC to conduct research on the coding of medical devices, investigated the electronic supervision of medicines and the retrospective pilot work of coding implantable medical devices in Shanghai. Based on the characteristics of medical devices and products, Equipment industry and regulation, taking into account the international development trend and drawing lessons from the practical experience of developed countries and regions, this paper puts forward the establishment of medical equipment code in China based on the guideline of government regulation and the implementation of enterprise main body.

In 2014, taking full account of the actual situation of regulatory and industrial development in our country, the study draws on the guidelines of IMDRF "Unique Identification of Medical Devices" and the core content of the US FDA "Medical Device Unique Identification System" regulations. According to "Regulations", "Medical Device Manuals and Labeling Regulations "And other relevant laws and regulations, with reference to" on the implementation of the national drug code management notice "and other documents, drafted the" medical device coding rules (Draft). "During the many held medical device coding seminar to solicit part of the medical equipment standard Technical Committee, medical device manufacturing, business enterprises, the use of units and information technology support unit's opinions and suggestions, the contents of the draft be amended.

In 2015, we closely track the progress and implementation of the international UDI laws and regulations and make use of opportunities such as international forums to discuss in depth the formulation of code rules and specific requirements. At the same time, on the basis of paying attention to the relevant national policies and industrial development trends and combining the latest technological achievements, For the scope of application, coding requirements and database construction, the "medical device coding rules (draft)" to further modify and improve.

In 2017, the SAIC convened a working conference on medical device coding to determine the general idea of ​​the construction of the medical device coding system and formulated the Work Plan for the Construction of Medical Device Coding System to gradually implement the coding.On the implementation level, the establishment of laws and regulations - standards - Database three-tier system, first of the coding rules to guide the development of coding work; and then respectively from the unique identification, data carriers and databases to develop standards and guidelines for coding standardization work; according to the coding application needs, and gradually carry out medical equipment coding information construction. In accordance with the Work Plan for the Construction of Medical Device Coding System and the agreed opinions of the meeting, a Code of Medical Device Coding (Draft for Comment) was formed, which is in line with international standards and conforms to the unique identification of medical device as the identity of the medical device and avoids Confused with titles such as classification codes, clarified understanding and common understanding of all parties, and revised the Code of Medical Device Encoding Rules (Draft for Comment) to the Rules for the Unique Identification System of Medical Devices (Draft for Soliciting Opinions) after repeated research and demonstration.

The Rules for the System of Unique Identification of Medical Devices (Draft for Soliciting Opinions) aims at clarifying the composition of the unique identification system of medical devices, and uniquely identifying the definitions of the components of the system and the related requirements. It is the basis for establishing a unique identification system for medical devices.

The Rules for the System of Unique Identification of Medical Devices (Draft for Soliciting Opinions) consists of five chapters and a total of 17. Chapter I General Provisions, a total of four, clearly define the legislative purposes, applicable objects, definitions and related responsibilities of the General Office. A total of four unique identification requirements, a clear definition of the medical device unique identifier, structure, basic principles and create requirements; Chapter III unique identification data carrier requirements, a total of four clear identification of the unique identifier of the carrier, the requirements given; Chapter IV unique identification database requirements, a total of three, a clear identification of the contents of the database and the requirements, data upload, maintenance requirements; Chapter V of the annex, the parties identified the unique identification requirements, the definition of related terms and the implementation date. The details are as follows:

(1) Article 1 of the General Provisions sets forth the legislative purpose and basis for the formulation of the rules, and defines the purpose of establishing a unique identification system for medical devices in accordance with the "Regulations" and the "13th Five-Year Plan for Pharmaceutical Safety" The unique identification of a device is a unified identification of a medical device from the source, which is conducive to strengthening the supervision and management of the development, production, operation and use of medical devices, enhancing the overall effectiveness of medical device regulation and innovating the regulatory model of medical devices.

(2) Article 2 of the General Provisions clarifies the applicable object of the rules, and clarifies that the rules apply to all medical devices sold and used in the territory of the People's Republic of China.

(C) Article III of the General Provisions clarify the scope of application of the rules.Utilizing the UDI regulations and guidelines in the U. S. FDA and IMDRF, the contents of the UDI system construction, the medical device unique identification, unique identification data carrier, unique identification database, Trinity Constitute a unique identification system for medical devices for the uniform identification of medical devices.

(4) Article 4 of the General Provisions clarifies the relevant duties of the General Administration According to the "13th Five-Year Plan" drug Safety Planning "requirements, made it clear that the establishment of the General Administration medical instruments Uniquely identify the system, formulate and publish the implementation plan for the unique identification system of medical devices, and provide a basis for the SAIC to formulate a phased and sub-type implementation plan and specify the time-limits and requirements for implementing different products.

(V) Articles 5 to 7 of Chapter 2 define the definition, structure and principles of unique identification of medical devices, draw reference from relevant international regulations, and make clear that the unique identification of medical devices is a series of letters presented on the product or packaging Digital code is the only identification of medical devices, it is clear that the unique identification of medical devices consists of product identification and production identification, and the basic principle of unique identification of medical devices is defined, the unique identification is related to the basic characteristics of products and should conform to Uniqueness, stability and scalability.It emphasizes that uniqueness is the first principle, the basis for ensuring accurate product identification, the only core principle that identifies functions, and because of the complexity of medical device products, the unique identification of medical devices Uniqueness is consistent with the requirements of product identification, for the same characteristics of medical devices, the only unique identifier should point to a single specification model products; for serial number production control medical devices, the only unique identification should point to a single product ; But for the control of production in accordance with the batch of products, the only unique identifier One point to the same batch of products.

(VI) Article VIII of Chapter 2, which defines the requirements for creating the subject and the relevant standards for the unique identification.Firstly, based on the "Regulations", the subject that is uniquely identified is the registered or registered medical device, which is responsible for creating and Maintaining a unique identity, emphasizing the principal responsibility of the registrant or the record holder, at the same time a clear business, the use of units can not create a unique identity, and strengthen the source code.Second, a clear medical device unique identification standards can be approved by the General Administration of Customs issued the relevant standards And the relevant standards formulated by the General Administration of Customs, which reflect the compatibility of the rules. They not only accept the unique identification of medical devices that have been prepared in accordance with internationally accepted standards but also those that are willing to adopt our own standards enterprise Reserved space.

(G) Articles IX to XII of Chapter 3 clarify the definition of a unique identifier data carrier, which uniquely identifies the data carrier form, coding subject and related requirements, defines the unique identifier data carrier form, and can adopt one-dimensional Code, two-dimensional code or radio frequency tag, and encourage the use of advanced data carrier technology, embodies the "rules" for the openness of advanced technology.Decides the need for medical devices at all levels of the sales unit packaging code, for reusable Of medical devices need to be encoded in the medical device product itself, emphasizing that the unique identifier data carrier should be robust, clear and readable during circulation and use, and ensure that medical devices are identifiable over the life of the device.

(Viii) Article 13 to Article 15 of Chapter 4 clarifies the content contained in the unique identification database of medical devices and uniquely identifies the main body of the database construction, stipulates the responsibilities of registrants or fillers of medical devices, and emphasizes that enterprises The first responsibility for the authenticity of the data and accuracy of the first clear medical device registrants or filing of product identification and related data points and time requirements.It is clear that the administration is responsible for organizing the establishment of a medical device unique identification database, unique identification database Is a static database that contains the product identification part of the medical device unique identifier and other data.

(Ix) The Supplementary Provisions make it clear that the food and drug regulatory authorities at all levels can call and manage the relevant data, and encourage the units that manufacture, operate and use the medical devices to apply the unique identification of the medical devices in the product-related management.The value of the unique identification of medical devices is embodied in the application, The effective use of a unique identifier for all aspects of management is the basis for the formation of medical device monitoring big data, is the implementation of the Internet + regulation, an important means of regulation and wisdom.Many technical and technical terms were explained.