Beijing Municipal Medical Products Administration | Unique identification of medical devices consulting Q&A,ZOOP

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Beijing Municipal Medical Products Administration | Unique identification of medical devices consulting Q&A

Question 1: What are the regulations on the unique identification of medical devices?

Answer1:

(1) Article 38 of the Regulations for the Supervision and Administration of Medical Devices : According to the category of medical devices, the state implements the unique labeling system for medical devices step by step, making sure the medical device is traceability. Specific measures shall be formulated jointly by the Beijing Municipal Medical Products Administration and administrative department under The State Council and other relevant departments under The State Council.

(2) Article 101 of Administrative Measures for Registration and Filing of Medical Devices: The State Medical Products Administration established and implemented the unique labeling system for medical devices step by step. The applicant and the record holder shall submit the information related to the unique identification in accordance with relevant provisions, and ensure that the data are true, accurate and traceable.

(3)Article 101 of Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents: The State Medical Products Administration established and implemented the unique labeling system for medical devices step by step. The applicant and the record holder shall submit the information related to the unique identification in accordance with relevant provisions, and ensure that the data are true, accurate and traceable.

(4) Measures for the supervision and administration of medical device production Article 36 medical care Device registrant Filing person The entrusted production enterprise shall implement medical treatment in accordance with the state Relevant requirements for unique identification of devices,Carry out code assignment Data upload and maintenance update, Ensure the authenticity of information accuracy Complete and traceable.

Article 79: Under any of the following circumstances, Medical Products Administration shall order correction within a prescribed time limit according to its duties; Those who refuse to make corrections shall be fined not less than 10,000 yuan and not less than 50,000 yuan; If the circumstances are serious, they shall be fined not less than 50,000 yuan but not more than 100,000 yuan:

（2）Failing to organize and carry out code assignment, data uploading, maintenance and update in accordance with the relevant requirements of the State for the implementation of unique identification of medical devices.

5. Article 30 of Measures for Supervision and Administration of Medical Device Business: Medical device business enterprises shall establish and implement a product traceability system to ensure that products can be traced back.

Medical device enterprises shall implement the unique labeling system for medical devices in accordance with relevant state regulations.

Question 2: What is the unique identification of medical devices?

Answer2 : Unique Device Identification (UDI for short) refers to the code composed of numbers, letters or symbols attached to medical Device products or packages for Unique Identification of medical devices.

(Article 3 of Rules for Unique Identification System for Medical Devices)

Question 3 : What constitutes a unique identification system for medical devices?

Answer3: It consists of unique medical device identification, unique medical device identification data carrier and unique medical device identification database.

(Article 3 of Rules for Unique Identification System of Medical Devices)

Question 4: What is the unique identification data carrier of medical devices?

Answer4 : It refers to the data media that stores or transmits the unique identification of medical devices. Such as one-dimensional code, two-dimensional code or radio frequency tag.

(Article 3 and Article 11 of Rules for Unique Identification System for Medical Devices)

Question 5 : What is the unique identification database for medical devices?

Answer5 : It refers to the database of product identification and associated information that stores the unique identification of medical devices.

(Article 3 of Rules for Unique Identification System for Medical Devices)

The database shall be organized and constructed by the National Medical Products Administration, and the registrant/record holder shall upload the uniquely identified product identification and associated information to the database in accordance with relevant standards and specifications, and shall be responsible for the accuracy and uniqueness of the data. Medical device enterprises, medical institutions, relevant government departments and the public can share uniquely identified data through data query, download and data docking.

(Interpretation of Unique Identification System Rules for Medical Devices)

Question 6 : What identification information does the unique identification of medical devices include?

Answer6: The unique identification of medical devices includes Device Identifier (UDI-DI) and Production Identifier (UDI-PI).

(Article 7 of Rules for Unique Identification System of Medical Devices)

Question 7: What is the product identification (DI) in the unique identification of medical devices?

Answer7 : It is the unique code to identify the registrant/record holder, model and specification of the medical device and packaging. Usually include: package indicator, manufacturer identification code, item code, check code.

(Article 7 of Rules for Unique Identification System of Medical Devices)

Question 8：What is the production identification (PI) in the unique identification of medical devices?

Answer8 : It is composed of codes of information related to the production process of medical devices. According to the requirements of supervision and practical application, it can include serial number, production lot number, production date, expiration date, etc.

(Article 7 of Rules for Unique Identification System of Medical Devices)

Question 9: What are the requirements for the unique identification of medical devices?

Answer9: UDI should be unique, stable, and extensible

(Article 8 of Rules for Unique Identification System of Medical Devices)

Question 10: What does the uniqueness of medical device unique mark mean?

Answer10 : It is the basis to ensure the accurate identification of products and the core principle of the unique identification function. Due to the complexity of medical device products, uniqueness should be consistent with 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, only the same batch of products; For medical devices controlled by serial number manufacturing, uniqueness should be directed to a single product.

(Interpretation of Regulations on Unique Identification System for Medical Devices)

Question 11 : What is the stability of the unique identification of medical devices？

Answer11: It means that once the unique label is assigned to the medical device product, the product label should remain unchanged as long as its basic characteristics do not change. When the sale and use of medical devices are stopped, the product labels shall not be used for other medical devices. When resold, use, may use the original product mark.

(Interpretation of The Unique Labeling System Rules for Medical Devices)

Question 12: What is scalability uniquely identified for medical devices?

Answer 12: It means that the unique mark shall be adapted to the continuous development of regulatory requirements and practical applications. The word "unique" does not mean serial number management for a single product. In unique identification, production identification can be used together with product identification to achieve the uniqueness of the three levels of specification model, batch and single product, so as to meet the current and future identification requirements for medical devices.

(Interpretation of The Unique Identification System Rules for Medical Devices)

Question 13: What are the qualifications, responsibilities and obligations of a code issuing agency?

Answer 13: The issuing institution of the unique device identifier shall be a legal entity within the territory of China, with a sound management system and operation system to ensure the uniqueness of the unique medical device identifier created in accordance with its standards, and meet the relevant requirements of China's data security.

The code issuing institution shall provide the registrant/record holder with the procedures for implementing its standards and provide guidance for implementation. In order to facilitate the registrant/record holder to master the coding standards of the issuing institution for selection or application by relevant parties, the issuing institution shall upload its coding standards to the unique identification database of medical devices and maintain them dynamically. Before January 31 of each year, the code issuing institution shall submit to the National Medical Products Administration a report of the previous year on the unique marks created in accordance with its standards.

Medical device unique identification system be unscramble

(Interpretation of Regulations on Unique Identification System for Medical Devices)

Question 14: At present, which coding agencies meet the requirements？

Answer 14: They are "China Article Coding Center", "Zhongguancun Industry two-dimensional code Technology Research Institute" and "Ali Health Technology (China) Co., LTD.".

Question 15: What is the corresponding code system of the three issuing agencies？

Answer 15:

The code issued by China Article Coding Center is GS1 code;
"Zhongguancun Industry two-dimensional code Technology Research Institute" issued code for MA code;
The code issued by ali Health Technology (China) Co., Ltd. is AHM code.

Question 16: What information is a GS1 code made up of?

Answer 16:

DI：The manufacturer identification code consists of 7 to 10 digits, which is assigned and managed by China Article Code Center. The prefix code is the first three bits of the manufacturer identification code, and the prefix code assigned to China Article Coding Center by the International Article Coding Association is 690-699. The item code of the commodity shall be allocated by the owner of the company identification code (i.e. the member of the commodity bar code system) according to the relevant national standards. The check code is derived from the standard algorithm.

PI: Including medical device serial number, production lot number, production date, expiration date, etc.

(GS1 Standard based on the Unique Device Identification (UDI) specification to achieve medical device traceability - China Article Coding Center)

Question 17 :What information is MA code made up of?

Answer 17:

DI: contains three bits of the national prefix code. Industry identifier 2 bits; Registration code 6 digits; Package indicator 1 bit; Product code 6 bits; The parity code consists of one bit.

PI: contains medical device serial number, production lot number, production date, expiration date, etc.

(UDI Coding Service platform - idcode.org.cn)

Question 18 :What information is an AHM code made up of?

Answer 18:

The first part is product resource code: the first 7 digits of traceability code, including enterprise information, drug name, dosage form, approval number, package specifications and other information, facilitate product identification;

The second unit is a single item sequence: the tracking code is 8 to 16 bits, which is the serial number of a single item.

The last element is the check bit: the trace code is 17 to 20 bits, and the check bit is generated by a special encryption algorithm.

(Code specification for drug traceability code of "Safe on Code" traceability platform)

Question 19 : What are the forms and requirements for UDI data carriers?

Answer 19: The unique identification data carrier of medical devices should meet the requirements of automatic identification, data collection technology and manual reading. Automatic identification and data acquisition technologies include one-dimensional codes, two-dimensional codes or radio frequency tags. When one-dimensional code is used, product identification and production identification can be connected in series or in parallel. When radio frequency tags are used, both one-dimensional codes and two-dimensional codes should be available.

(Article 11 of Rules for Unique Identification System of Medical Devices)

Question 20: How to select the unique identification data carrier for medical devices?

Answer 20 : One-dimensional code is a bar code symbol that only represents information in one dimension direction. It has been mature for many years and has low cost. It can be well compatible with existing code scanning equipment on the market, but one-dimensional code takes up a large space and has poor damage correction ability.

QR code is a barcode symbol representing information in the two-dimensional direction. Compared with one-dimensional code, the QR code can hold more data, which can play a good role when the device packaging size is limited and has certain error correction ability. However, the requirements for reading equipment are higher than that of one-dimensional code.

An RF tag can store information, receive the electromagnetic modulation signal from the reader, and send back to the corresponding signal data carrier. Although the carrier cost and reading equipment cost of RFID are higher than one-dimensional code and two-dimensional code, RFID access fast, and batch reading can be realized and can play a role in some links and fields.

The registrant/record holder can select the appropriate unique identification data carrier for medical devices according to the product characteristics, value, main application scenarios and other factors.

(Interpretation of Unique Identification System Rules for Medical Devices)

Question 21: What are the first batch of medical equipment unique identification varieties?

Answer 21: There are 69 kinds of 9 categories including active surgical instruments, passive surgical instruments, neurological and cardiovascular surgical instruments, medical imaging instruments, blood transfusion, dialysis and extracorporeal circulation instruments, active implantation instruments, passive implantation instruments, infusion, nursing and protective instruments and ophthalmic instruments.

(Announcement of the National Medical Products Administration, The State Health Commission and the State Medical Insurance Administration on Furthering the Pilot Project to Implement the First Batch of Unique Labeling for Medical Devices (No. 106, 2020))

Question 22: When will the implementation of the second batch of unique identification of medical devices be launched?

Answer 22: It will be implemented on June 1, 2022.

(Announcement of the State Food and Drug Administration, State Health Commission, State Medical Insurance Administration on The Implementation of the Second Batch of Unique Identification of Medical Devices (No. 114, 2021))

Question 23: What does the second batch of medical equipment only identify the implementation of varieties?

Answer 23: On the basis of the first batch of implementation (69 types of 9 categories specified in), the rest of the third category of medical devices (including in vitro diagnostic reagents) were included in the scope of unique labeling in the second batch of implementation.

Question 24: What does a medical device registrant need to do to implement unique labeling?

Answer 24: Unique identification code: medical devices produced shall have unique identification of medical devices.

Submission of unique Identification Registration System: When applying for initial registration, renewal registration or registration change, the registration applicant/registrant shall submit the product identification of its minimum sales unit in the registration management system.

Submission of unique identification database: The registrant shall upload the product identification and related data of the smallest sales unit and higher-level packaging to the unique identification database of medical devices in accordance with relevant standards or specifications before the medical devices are put on the market for sale to ensure that the data are true, accurate, complete and traceable. For medical devices whose information has been maintained in the medical medical consumables classification and code database of the National Medical Insurance Administration, the fields of medical medical consumables classification and code should be supplemented and improved in the unique identification database, and the information related to the unique identification of medical devices should be improved in the maintenance of the medical medical consumables classification and code database. And confirm the consistency with the unique identification data base data of medical devices.

In case of any change in the product identification data of the minimum sales unit of medical device, the registrant shall make the change in the unique identification data database of medical device before the product is put on the market for sale, so as to realize data update. When the product identification of the minimum sales unit of medical devices changes, data shall be uploaded to the unique identification database of medical devices in accordance with the newly added product identification.

Question 25：What are the responsibilities of the registrant in the implementation of unique identification of medical devices?

Answer 25: It is necessary to effectively implement the responsibility of enterprises, encourage the establishment of a sound traceability system based on unique identification, and do a good job in product recall, tracking and traceability. If the product management category changes due to the dynamic adjustment of the Catalogue of Medical Devices classification, the medical device registrant shall implement unique identification according to the requirements of the adjusted management category.

Question 26: What are the responsibilities of the operating enterprise in the implementation of the unique identification of medical devices?

Answer 26: It is necessary to actively apply unique identification in business activities, do a good job of entering and leaving the warehouse with code, and realize traceability of products in the circulation link.

Question 27: What are the responsibilities of the operating enterprise in the implementation of the unique identification of medical devices?

Answer 27: It is necessary to actively apply unique identification in business activities, do a good job in warehousing and warehousing with code, and realize traceability of products in circulation.

Question 28: What are the responsibilities of code issuing institutions in the implementation of unique identification of medical devices?

Answer 28: The establishment standards and guidelines for the institution's unique identification shall be formulated to guide the medical device registrants to create and assign unique identification, and verify the legibility of the unique identification prepared in accordance with its standards in circulation and use.
(Announcement of the State Food and Drug Administration, State Health Commission, State Medical Insurance Administration on The Implementation of the Second Batch of Unique Identification of Medical Devices (No. 114, 2021))

Question 29: Who is responsible for creating, assigning and maintaining the unique identification of medical devices?

Answer 29:The registrant/record holder shall be responsible for creating and maintaining unique identification of medical devices in accordance with these Rules, assigning data carriers with unique identification of medical devices to products or packages, uploading relevant data, and strengthening the management of the whole process of products with unique identification of medical devices. Enterprises and users of medical devices are encouraged to actively use the unique identification of medical devices for related management.

(Article 6 of Rules for Unique Identification System for Medical Devices)

Question 30: What are the standards for unique identification of medical devices?

Answer 30:Current relevant standards are:
YY/T 1630-2018 Basic Requirements for Unique Identification of Medical Devices
YY/T 1681-2019 Basic Terms of Unique Identification System for Medical Devices
YY/T 1752-2020 Basic Data Set of Unique Identification Database of Medical Devices
YY/T 1753-2020 Guide to Filling in Database of Unique Identification of Medical Devices

The latest content can be found by searching "Unique Identification of Medical Devices" on the website of China National Institute for Food and Drug Control.

Website:

http://app.nifdc.org.cn/jianybz/jybzTwoGj.do?formAction=listQxtjbz

Question 31: Which packaging levels require unique identification of medical devices?

Answer 31: The registrant/record holder shall select the data carrier standard suitable for the unique identification of the medical device created by the registrant/record holder, the minimum sales of medical devices listed in the name of the unit and a higher level of packaging or medical device products gives a unique identifier data carrier, and to ensure that during the medical equipment management using a unique identifier data carrier is firm and clear and readable.

(Article 12 of Rules for Unique Identification System of Medical Devices)

Question 32: Who is responsible for uploading, maintaining and updating the relevant data in the unique identification database of medical devices?

Answer 32: The registrant/record holder shall upload, maintain and update the relevant data in the database with unique identification in accordance with relevant standards or specifications, and shall be responsible for the authenticity, accuracy and integrity of the data.

(Article 14 of Rules for Unique Identification System for Medical Devices)
For more information about specific requirements for data filling, please visit the unique identification database of medical devices:

Website: https://udi.nmpa.gov.cn/

Question 33: At what stage should registrants/record holders submit information related to unique identification of medical devices?

Answer 33: The registrant/record holder shall submit the product identification in the registration/record management system when applying for medical device registration, registration change or filing. The registrant/registrant shall upload the product identification and relevant data to the unique identification database of medical devices before the products are put on the market for sale.

(Article 15 of Rules for Unique Identification System for Medical Devices)

Question 34: Does the registrant/recorder need to upload production identification (PD information) to the medical device Unique identification database?

Answer 34: No. The registrant/record holder only needs to fill in what the production label (PI) contains, like batch number, serial number, production date and expiration date in the unique identification database of medical devices, as shown in the figure for example:

Question 35: What are the ways for business enterprises and medical institutions to obtain product identification and related data from the unique identification database of medical devices?

Answer 35: Medical device enterprises, medical institutions, relevant government departments and the public can log in UDI database to select data query, data download and data docking and other ways to share uniquely identified data.
(Interpretation of The Unique Identification System Rules for Medical Devices)

Question 36: What are the key points for registrants/registrants to implement unique identification of medical devices?

Answer 36: Implement key points including but not limited to: choose sending agency, distribution, product identification, clear packaging level and corresponding relationship identification, selection, determine the production data carrier specification placed carrier, improve the label design, to carry out the assigned a code compliance checks, validation to upload data, upload the data to the UDI database as required, release and maintain data in a timely manner.

Question 37: What kind of unique medical device identification can medical device business enterprises carry out?

Answer 37: Medical device business enterprises should strengthen the study of regulations and standards related to the unique identification of medical devices, and fully understand the specific plan of the registrant/record holder of the product to implement the unique identification. At the same time, combined with the actual situation of the enterprise, according to the requirements of relevant laws and regulations on business links and business quality management standards, the active application of unique identification for business management, such as procurement, warehousing, storage, warehousing, upstream and downstream traceability. Enterprises with a wide range of business and diversified business models need to consider the supporting measures of multi-code parallel and continuously improve the level of information management.

Question 38: What are the printing quality acceptance standards in identification data carrier in one-dimensional code, two-dimensional code？

Answer: 38 :There are specific standards for identifying print quality acceptance levels for data carriers, One-dimensional code printing quality acceptance grade (GB T 18348-2008 barcode printing quality inspection), two-dimensional code printing quality acceptance grade (GB/T 23704-2017 two-dimensional barcode printing quality inspection) acceptable symbol grade standard ≧Ml.5.

UDI of grade C or above is easy to read by the supply chain.

Question 39: What are the commonly used AI identifiers for medical device unique identification system using GS1 code system?

Answer 39: Commonly used GS1 AI identifiers are the following:

Question 40: How to use the UDI-DI under GS1 standard?

Answer 40: UDI-DI can be identified by global Trade Project Code (GTIN). Medical products GTIN commonly have 12, 13 and 14 structures, domestic products

The commonly used structures are GTIN-13 and GTIN-14, as shown in the figure below.

GTIN-13 is used for packaging a single sales unit. For the rules, see GB12904 commodity Barcode Retail Commodity Code and Barcode Representation. GTIN-14 is generally used for combined packaging of multiple sales units. For the rules, see GB/T 16830 "Barcode code and Barcode Representation of Commodity Storage and Transportation Packaging".

In addition, the allocation of medical device GTIN should follow the GS1 Guidelines for The Allocation of Medical Products GTIN. The online decision tool for medical GTIN allocation can also be used to help determine whether a new ALLOCATION of GTIN is needed.

Question 41: Should UDI-DI differ for different packaging levels of the same product? How to use GTIN for identification?

Answer 41: Different packaging levels should be marked with different UDI-DI, which can be identified in the following two ways:

(1) Each package level is marked with a different GTIN-13;

(2) The minimum sales unit package uses GTIN-13, and the higher level package will be identified with GTIN-14 with the same product item code and different package indicator as the minimum sales unit.

(For detail information, please see Chapter 4 of GS1 Medical Product GTIN Allocation Guidelines for details)

Question 42: How to use the UDI-PI under GS1 standard?

Answer 42: UDI-PI can be represented by application identifier (AI), as shown in the following table.

X is an alphanumeric character and N is a number. For the coding rules, see GB/T 16986 Application Identifier of Barcode for Commodity.

Question 43: How to determine the order of UDI-PI in GS1 standard UDI?

Answer 43: If the UDI-PI contains both predefined length identifiers (such as expiration date and production date) and non-predefined length identifiers (such as batch number and serial number), the predefined length identifiers should be placed first.

Encoding example:

(01)06901234567892(11)141231(17)150707(10)A213B1(21)1234

For the rules, see 7.8.5.3 Other considerations for link use in GS1 General Specification.

Question 44: What are the components of UDI-DI in the MA medical device Unique Identification coding rules?

Answer 44: The data string of product identification unit is coded "MA" and delimited ". , manufacturer's code, separator ". , product code, should appear as the first unit data string. Product identification unit data string is mandatory.

The manufacturer's code contains the country code with a 3-bit delimiter ". 1 bit, industry code 2 bit M0, delimiter ". 1 bit, 6 bits of registration code.

The product code consists of 1 bit package code, 6 bits project code and 1 bit verification code.

(Medical Device unique Identification MA (IDcode) Coding Manual)

Question 45: How to compile UDI-PI in MA Medical Device Unique Identification coding rules?

Answer 45: UDI-PI can be represented by data separators, as shown in the following table:

(MA (IDcode) Coding Manual for Unique Identification of Medical Devices)

Question 46: How do UDI standards correspond to AHM codes?

Answer 46: DI in UDI corresponds to manufacturer identification code + Product identification code PI in UDI corresponds to product batch information (BN) + product serial number (SN) + Product production date (MD) + Product warranty date (BD) + Product validity date (ED).

(Ali Health Medical Device unique identification code specification)

Question 47: How to interpret THE AHM code identifier?

Answer 47: The following codes are used as an example:

(Ali Health Medical Device unique identification code specification)

Question 48: How can a registrant/record holder fill in the data?

Answer 48: Web page filling, data template import and data interface exchange can be used to fill in the report.

(Guidance for filling in YY/T 1752-2020 Database of Unique Identification of medical Devices)

Question 49: How should businesses and healthcare organizations use the UDI database?

Answer 49: Medical device business enterprises should actively apply unique standard in business activities, do a good job in warehousing and warehousing with code, and realize product traceability in the circulation link.

Medical institutions should actively apply unique marks in clinical practice, such as clinical use, payment, settlement and reimbursement, and do a good job in the whole process with code records to achieve traceability of products in the clinical link.

Question 50: What should enterprises and medical institutions pay attention to when using GS1 standard UDI to automate the management of medical devices?

Answer 50 : In terms of hardware, it should be confirmed whether the scanning device can accurately read UDI information in various GS1 bar codes according to GS1 standards. Common GS1 bar codes include EAN/ UPC.ITF-14. Gs1-128 and GS1 DataMatrix, etc. EAN/ UPC.ITF-14 is applicable to UDI containing only UDI-DI.

In terms of software, it should be confirmed whether the system has a 14-bit field for storing GTIN in each relevant product packaging level (if GTIN is less than 14 bits, the preceding zero should be 14 bits), whether the system can verify the accuracy of GTIN and related information in the bar code, and whether it has the function of associating serial number, production lot number, production date and expiration date with GTIN and storing them.

Question 51: UDI carriers use standards-compliant GS1-128 or GS1 DataMatrix. Why can only read a long string of numeric characters when using link scan code, not separated by different application identifiers?

Answer 51: It is recommended to confirm whether the barcode scanning device is set to read the corresponding barcode in GS1, and whether the relevant software and hardware process the barcode according to THE GS1 standard. The data processing process of GS1 barcode is shown in the figure below. See GS1 Barcode symbol processing process in GS1 General Specification 7.8 for details.

11.1.jpg

Question 52：Does the implementation of UDI mean traceability is achieved?

Answer 52: Regulations on The Supervision and Administration of Medical Devices (Order No. 739 of The State Council of the People's Republic of China) mentioned that "the state implements the unique identification system of medical devices step by step according to the product category of medical devices to realize the traceability of medical devices". The Notice of sFDA on matters related to the implementation of the first batch of unique identification of medical devices (No. 72, 2019) also mentioned that "registrants are encouraged to establish an information traceability system for medical devices with unique identification of medical devices, so as to realize full traceability of the production, circulation and use of their products. Medical device manufacturers and users are encouraged to actively apply unique medical device labels in their related management activities, explore the establishment of a traceability chain with upstream and downstream, and promote the connection of applications."

UDI system can realize the recording of medical device identification and product master data. The implementation of traceability also requires each link of the supply chain to record product history, location or application information through the traceability system.

Question 53: What are the steps to implement UDI in healthcare facilities?

Answer 53:

(1) Team building: It involves all clinical departments, functional departments of consumable management and information department, and requires the leadership of the hospital to implement the application uniformly.

(2) Study relevant laws and policies: UDI regulations, policies, standards, etc.

(3) System transformation: Involving various systems in the hospital, based on UDI database segment standard, the system database architecture was reformed to realize the function of automatically filling data into the system through scanning. Upgrade the code scanning device.

(4) Obtaining national UDI data: Choose interface interconnection or download to obtain the UDI database of the National Office.

(5) DI cross-code: The "hospital self-coding, DK medical insurance classification code, billing code" is associated with the reference code.

(6) Application: UDI related records should be applied in various scenarios such as procurement, receipt, acceptance, warehousing, warehousing, use, settlement and adverse events. Establish hospital traceability system.

Question 54: Why should the data of consumables in medical institutions be coded?

Answer 54: The main reasons for the data of medical consumables are as follows:

(1) Connect with national UDI data database to ensure the quality of consumables entering the hospital.

(2) Improve the efficiency of UDI code scanning. After UDI is implemented in the hospital of medical institutions, UDI codes are scanned when the physical objects enter the hospital. If the data of hospital consumables is not mapped with DI, UDI codes cannot be analyzed. At the same time, the authenticity of the physical consumables cannot be confirmed by the matching check between DI in the physical UDI label and DI in the national UDI database.

(3) DI has the unique identity attribute of medical consumables, and the existing consumables data can be obtained from the NATIONAL UDI database through pair code mapping, which is conducive to the management of the unique identity of hospital consumables data.

Question 55: How to perform DI code matching in medical institutions?

Answer 55: Manual code matching is of great workload and low efficiency. The UDI Service Public Interest Platform can be used for automatic code verification. After registering and logging in to the platform, users can use the function modules of UDI-DI matching code, standardized data diagnosis and qualification management for free.

Platform: China Medical Device Information Network

(https://www.cmdi.org.cn/) Home page can be logged in

Direct access to the website:

http://udi.cmic.com.cn/udi/#/login

Question 56: Why can't I log in to UDI public service platform after registration?

Answer 56: UDI public service platform is for users of medical institutions to use. When registering, they need to upload the practicing license of medical institutions. After the registration is submitted, the platform will approve the account (usually 1-2 working days). Only after approval can you log in and use it. If you have any problems during use, you can call 010-84438357 for free consultation.

Question 57: Why is the to-code ratio so low?

Answer 57: The use of UDI service public welfare platform for code matching essentially means that the data of medical institutions are automatically mapped to the data of national UDI database. The reasons for the mismatch are as follows:

(1) The data of medical institutions are not standardized. The data in the national UDI database are filled in by manufacturers according to the information of medical device registration certificate. If there is any difference between the two parties' data, it cannot be automatically matched.

(2) There is no such data in the national UDI database. At present, the data in the national UDI database are reported by manufacturers according to the progress requirements of national UDI promotion, and not all the data of medical devices have been reported.

Question 58: Can DI code be mapped to consumable national medical insurance classification and code at the same time?

Answer 58: The DI code main database is the national UDI database, and the national Medical insurance classification and code main database is the National Medical Insurance Administration database. The construction subject and data content of the two databases are different, and the underlying mapping of the two databases is not carried out at present. But the two databases are provided by the manufacturer, the manufacturer also gradually in sync with a database maintenance two coded information, so, when making DI to code, if countries UDI database uploaded the consumables health classification and code, the DI of yards, consumables national health classification and code synchronization mapping.

Question 59: Where can I contact if I have problems related to UDI database operations during UDI implementation?

Answer 59: Questions can be submitted through the HELP Desk website of the NATIONAL Food and Drug Administration unique Identification Database for medical devices.

Question 60: How do I inquire about UDI policies and documents?

Answer 60:

You can inquire to national food and Drug administration official website, specific address:

https://udi.nmpa.gov.cn/toMessageList.html?flag=2

Also can inquire to Beijing food and Drug administration official website, specific address:

http://yjj.beijing.gov.cn/yjj/ztzl48/ylqxjgfwzn/ylq xsc47/index.html

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