Question 1: What are the regulations on the unique identification of medical devices
Answer1:
(1) Regulations on the supervision and administration of medical devices Article 38 country According to the product category of medical devices,Implement the unique identification system of medical devices step by step, Traceability of medical devices,The specific measures shall be formulated by the drug regulatory department under the State Council Formulated jointly with relevant departments of the State Council.
(2) Administrative measures for registration and filing of medical devices Article 101 The State Drug Administration shall establish and implement the unique identification system for medical devices step by step degree,applicant The filing person shall submit a letter with unique identification in accordance with relevant provisions interest,Ensure data authenticity accuracy traceability . (3) Administrative measures for registration and filing of in vitro diagnostic reagents One hundred and first strip The State Drug Administration shall establish and implement the unique identification of medical devices step by step system,applicant The filer shall submit the unique identification in accordance with the relevant provisions information,Ensure data authenticity accuracy traceability . (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,By the drug regulatory department Order correction within a time limit according to duties Refusing to correct,place1More than 10000 yuan5Wan Yuanyi Impose a fine Serious,place5More than 10000 yuan10Fine below 10000 yuan two Failure to comply with the relevant national requirements for the unique identification of medical devices, Organize code assignment Data upload, maintenance and update. 5 Measures for the supervision and administration of the operation of medical devices Article 30 Medical device Machinery trading enterprises shall establish and implement a product traceability system,Ensure product traceability Trace. A medical device business enterprise shall implement medical devices in accordance with the relevant provisions of the state Equipment unique identification system. Question 2: What is the unique identification of medical devices Answer2 : Unique identification of medical device Unique Device Identification,abbreviationUDI ,It refers to the products or packaging of medical devices Attached,By number A code consisting of letters or symbols,For medical treatment Unique identification of the device. Rules for unique identification system of medical devices The first Three articles Question 3 : What is the unique identification system of medical devices Answer3: Unique identification by medical device Unique identification data carrier of medical device And medical device unique identification database. Unique identification system of medical devices Unified rules Article 3 Question 4: Unique identification by medical device Unique identification data carrier of medical device And medical device unique identification database. Unique identification system of medical devices Unified rules Article 3 Answer4 : Unique identification by medical device Unique identification data carrier of medical device And medical device unique identification database. Unique identification system of medical devices Unified rules Article 3 Question 5 : What is the unique identification database of medical devices Answer5 : It refers to the product identification and related information storing the unique identification of medical devices Database of. Rules for unique identification system of medical devices Article 3 The database is organized and built by the State Drug Administration,By registrant/ The filer shall provide the unique product identification and related information in accordance with relevant standards and standards Upload specification to database,And the accuracy of the data Sole responsibility.medical care Equipment business enterprise medical institution Relevant government departments and the public can use the data query download Share unique identification data by means of data docking. Medical device Mechanical unique identification system rules unscramble Question 6 : What identification information does the unique identification of medical devices include Answer6: The unique identification of medical devices includes product identification Device Identifier, UDI-DI And production identification Production Identifier, UDI-PI . Rules for unique identification system of medical devices Article 7 Question 7: Product identification in the unique identification of medical devices DI What is it? Answer7 : Identification of registrant/Filing person Model, specification and packaging of medical devices Unique code for.Usually include Package indicator Vendor identification code commodity Project code Check code. Rules for unique identification system of medical devices Article 7 Question 8 : Production identification in the unique identification of medical devices PI What is it? Answer8 : It is composed of codes of information related to the production process of medical devices,according to Regulatory and practical application requirements,May include medical device serial number batch number date of manufacture Expiration date, etc. Rules for unique identification system of medical devices Article 7 Question 9: What requirements should the unique identification of medical devices meet Answer9: UDIShould be unique Stability and scalability. medical care Device unique identification system rules Article 8 Question 10: What is the uniqueness of the unique identification of medical devices Answer10 : It is the basis for ensuring accurate product identification,Is a unique identifier that functions Core principles of.Due to the complexity of medical device products,Uniqueness should be related to property Consistent with product identification requirements,For medical devices with the same characteristics,Uniqueness should Point to single specification and model products For products controlled by batch production,only Uniformity refers to the same batch of products For medical devices with serial number production control Equipment,Uniqueness should point to a single product. Medical device unique identification system be unscramble Question 11 : What is the stability of the unique identification of medical devices Answer11: It refers to the unique identification once assigned to the medical device product,As long as its base This feature has not changed,The product identification should remain unchanged.When medical device Stop selling When used,The product identification shall not be used for other medical devices Resale When used,Original product identification can be used. Unique bid of medical device Recognition system rules unscramble Question 12: What is the extensibility of the unique identification of medical devices Answer 12: It means that the unique identification shall be continuously developed with the regulatory requirements and practical applications Adapt, only The term does not mean serialization of a single product Administration,In unique identification,Production identification can be used in combination with product identification, Implementation specification and model Uniqueness of three levels of batch and single product,So as to meet the current and future identification needs of medical devices. Unique identification of medical device System rules unscramble Question 13: What kind of qualification does the code issuing institution need,Its duties and responsibilities What are the services Answer 13: The issuing institution of the unique identification of the device shall be a legal person within the territory of China structure,Have perfect management system and operation system,Make sure to create according to its standards Uniqueness of unique identification of medical devices,And meet the relevant requirements of China's data security. The code issuing institution shall report to the registrant/The filer provides a process for implementing its standards And guide the implementation,For the convenience of registrant/The filer shall master the code of the code issuing organization standard,For selection or application by interested parties,The coding institution shall mark its coding standard It is transmitted to the unique identification database of medical devices and maintained dynamically.annually1month31day front,The code issuing agency shall submit to the State Drug Administration the documents created in accordance with its standards The unique identification of the report of the previous year. Medical device unique identification system be unscramble Question 14: At present, which coding agencies meet the requirements Answer 14: namely China article coding Center Zhongguancun Gongxin QR code Technology Research Institute and Ali Health Technology China limited company . Question 15: What is the coding system corresponding to the three coding institutions Answer 15: China article coding Center The issued code isGS1code Zhongguancun industry and information QR Code Technology Research Institute The issued code isMAcode Ali Health Technology(China)limited company The issued code isAHMcode. Question 16: GS1What information codes are composed of Answer 16: DI Manufacturer identification code7~10Digit composition,China article coding center is responsible for distribution and management.Front of manufacturer identification code3Bit codes are prefix codes, The prefix code assigned by the international article coding association to the China article coding center is690 - 699;The commodity item code is owned by the owner of the manufacturer identification code(Commodity bar Code system member)Self distribution according to relevant national standards The check code is calculated by the standard Law derived. PI:Including medical device serial number batch number date of manufacture invalid Date, etc. be based onGS1Standard unique device identification UDI Preparation of specifications to achieve medical Traceability of therapeutic instruments-China article coding Center Question 17 :MAWhat information does the code consist of Answer 17: DI Prefix code by country3position Industry identifier2position Registrant code 6position Package indicator1position Product code6position Check code1Bit composition. PI Including medical device serial number batch number date of manufacture invalid Date, etc. UDI Coding service platform- idcode.org.cn Question 18 :AHMWhat information does the code consist of Answer 18: The first part is the product resource code Before traceability code7position,Include enterprise information Drug name Dosage form Approval number Package specification and other information,convenient Product identification The second unit is the single piece sequence Traceability code8reach16position, Is a single item serial number The last unit part is the check bit Traceability code17reach20position,The check bit is generated by a special encryption algorithm. Don't worry about the code Code specification for drug traceability code of traceability platform Question 19 :UDIWhat forms and requirements does the data carrier have Answer 19:The unique identification data carrier of medical devices shall meet the requirements of automatic identification and number According to the requirements of acquisition technology and manual reading.Automatic identification and data acquisition technology Including one-dimensional code QR code or RF tag.When using one-dimensional code, Product identification and production identification can be connected in series,Multiple lines can also be connected in parallel Use radio frequency standard When signing,It shall have one-dimensional code or two-dimensional code at the same time. Unique bid of medical device Recognition system rules Article 11 Question 20: How to select the unique identification data carrier of medical devices Answer 20 : One dimensional code is a bar code symbol that represents information only in one-dimensional direction,answer It has been mature for many years,Low cost,It can be well compatible with the existing scanning codes on the market equipment,However, one-dimensional codes occupy a large space,Poor damage correction ability. QR code is a bar code symbol that represents information in two-dimensional direction,Compared to One dimensional code,The same space can hold more data,The device package size is affected The time limit can play a good role,Have certain error correction ability,But to know The requirement of reading equipment is higher than that of one-dimensional code. RF tag has the function of information storage,It can receive the electromagnetic modulation of the reader signal,And return the data carrier of the corresponding signal.Carrier cost and cost of RF tag The cost of reading equipment is higher than that of one-dimensional code and two-dimensional code,butRFIDRead speed Fast degree,Batch reading can be realized,It can play a role in some links and fields. Registrant/The filing person may, according to the characteristics of the product value Select the appropriate unique identification data carrier of medical devices due to the main application scenarios and other factors. Medical device Mechanical unique identification system rules unscramble Question 21: What are the first batch of medical devices with unique identification Answer 21: Including active surgical instruments Passive surgical instruments Neurological and cardiovascular Surgical instruments Medical imaging apparatus blood transfusion Dialysis and cardiopulmonary bypass devices Active implant Passive implant Injection and transportation Nursing and protective equipment Total ophthalmic devices9General category69species. State Food and Drug Administration and State Health Commission Opinions of the National Medical Insurance Bureau on further promoting the pilot and doing a good job in the first batch of medical devices Notice of identification work 2020Year106number Question 22: When will the implementation of the unique identification of the second batch of medical devices start Answer 22: to2022year6month1Effective from. State Food and Drug Administration country Circular of the National Health Commission and the National Medical Insurance Bureau on the implementation of the second batch of medical devices I. announcement of identification work 2021Year114number Question 23: What are the unique identification types for the second batch of medical devices? Answer 23: On the basis of 69 types of 9 categories specified in the first batch, the remaining third category medical devices (including in vitro diagnostic reagents) shall be included in the unique labeling scope of the second batch. (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 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. (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 25. What are the responsibilities of registrants in the implementation of unique identification of medical devices? Answer 25: It is necessary to implement the main responsibility of enterprises, encourage the establishment of a sound traceability system based on unique marks, 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. (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 26: What is the responsibility of the operating company 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 in warehousing and warehousing with code, and realize traceability of products in circulation. (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 27. What is the responsibility of the medical institution in the implementation of the unique identification of medical devices? Answer 27: Unique identification should be actively applied in clinical practice, such as clinical use, payment of fees, settlement of reimbursement, etc., and the whole process with codes should be well recorded to achieve traceability of products in the clinical process. (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 28: What is the responsibility of the code issuer in the implementation of the unique identification of medical devices? Answer 28: Standards and guidelines for the establishment of unique identifiers for the institution shall be formulated to guide medical device registrants to create and assign unique identifiers, and to verify the readability of unique identifiers in circulation and use in accordance with their standards. (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 unique identifiers for medical devices? Answer 29: The registrant/record holder is responsible for creating and maintaining unique identification of medical devices, assigning data carriers with unique identification of medical devices to products or packages, uploading relevant data, and strengthening product process management with unique identification of medical devices in accordance with these Rules. Enterprises and users of medical devices are encouraged to actively use the unique identification of medical devices for related management. (Article 6 of Regulations on Unique Identification System for Medical Devices) Question 30: What are the standards for unique identification of medical devices? Answer 30: Current relevant standards include YY/T 1630-2018 basic Requirements for Unique Identification of Medical Devices YY/T 1681-2019 Basic Terms for Unique Identification System of Medical Devices YY/T 1752-2020 Basic Data Set of Unique Identification Database of Medical Devices and 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. Web site: http://app.nifdc.org.cn/jianybz/jybzTwoGj.do?formAction=listQxtjbz Question 31: Which packaging classes require unique identification of medical devices? Answer 31: "Registrant/record should choose suitable to the unique identification of medical equipment and create a standard of data carrier, most small to listed in the name of the medical equipment sales unit and a higher level of packaging or medical device products give only a logo on the 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 Regulations on Unique Identification System for Medical Devices) Question 32: Who is responsible for uploading, maintaining and updating 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 uniquely identified database 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 information about specific requirements for data filling, please visit the unique identification database of medical devices (https://udinmpagovcn) Question 33: At what stage should registrants/registrants submit information about the unique identification of medical devices? Answer 33: "The registrant/record holder shall submit its product identification in the registration/record management system when applying for registration, registration change or filing of medical devices. 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 whether the production label (PI) contains 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 in which an enterprise or a medical institution can obtain product identification and related data from the unique identification database for medical devices? Answer 35: Medical device operators, medical institutions, government departments and the public can share uniquely identified data by logging into the UDI database and selecting data query, data download and data access. (Interpretation of Regulations on Unique Identification System for Medical Devices) Question 36: What are the usual key points at which a registrant/recorder implements unique identification of a medical device? Answer 36: implementation of the 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: Identification data carrier in one-dimensional code, two-dimensional code printing quality acceptance level standards? 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? Answer 39: GS1 format AI identifiers commonly used include the following identifiers Question 40: How to compile UDI-DI using GS1 standard? Answer 40: UDI-DI may be identified by the Global Trade Program Code (GTIN). Medical products GTIN commonly have 12, 13 and 14 structures, domestic products 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 different levels of UDI-DI be different for the same product? How to use GTIN for identification? Answer 41: Different levels of packaging should use different UDI-DI, which can be identified in the following two ways: (1) Each packaging level is marked with different GTIN-13; (2) The minimum sales unit shall be packaged with GTIN-13, and the higher level shall be identified by GTIN-14 with the same product project code and different package indicators as the minimum sales unit. (See Chapter 4 of GS1 Medical Product GTIN Allocation Guidelines for details) Question 42: How to compile UDI-PI using 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: When the UDI-PI contains both predefined length application identifiers (such as expiration date, production date) and non-predefined length application identifiers (such as batch number and serial number), the predefined length application 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 components of UDI-DI are included in the MA medical device Unique Identification coding rules? Answer 44: The product identification unit data string consists of the issuing authority code "MA" and the separator ". , 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: (Medical Device unique Identification MA (IDcode) Coding Manual) Question 46: How does the UDI standard correspond to the AHM code? 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 Manufacturing date (MD) + Product Warranty Date (BD) + Product effective Date (ED) (Ali Health Medical Device unique identification code specification) Question 47: How to interpret the AHM code identifier? Answer 47: Use the following code as an example: (Ali Health Medical Device unique identification code specification) Question 48: How can a registrant/record holder report data? Answer 48: Web pages, data template import, and data interface exchange are available. (Guidance for filling in YY/T 1752-2020 Database of Unique Identification of medical Devices) Question 49: How should businesses and healthcare institutions use the UDI database? Answer 49: Medical device business enterprises should actively apply unique standard in their 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. (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 50: What should enterprises and medical institutions pay attention to when using GS1 UDI to automate 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) and whether the system can verify the accuracy of GTIN and related information in the bar code. Is there a function to associate serial number, production lot number, production date, expiration date information with GTIN and store it? Question 51: UDI carriers use standards-compliant GS1-128 or GS1 DataMatrix. Why can only a long string of numeric characters be read when using a link scan, 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 processing process of the barcode data in GS1 is shown in the figure below. For details, see GS1 General Specification 7.8. Question 52: Is traceability achieved by implementing UDI? Answer 52: The Regulation on The Supervision and Administration of Medical Devices (Order No. 739 of The State Council of the People's Republic of China) mentions that "the state implements the unique labeling 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 taken to implement UDI in healthcare facilities? Answer 53: (1) Team building: involving all clinical departments, functional departments of consumables management and information department, which needs to be led by the hospital leaders for unified implementation and application. (2) Study relevant laws and policies: UDI laws, policies, standards, etc (3) System transformation: Involving all systems in the hospital, based on UDI database segment standard, system database architecture was transformed 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 Bureau. (5) DI cross-code: cross-code association is carried out for hospital self-code, DK medical insurance classification code and billing code. (6) Application: UDI related records are 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 cross-coding medical consumables data: (1) Connect with the national UDI data database and put the consumables into the quality control of the hospital. (2) Improve the efficiency of UDI code scanning in hospital. 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. The existing consumables data can obtain DI 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 does the DI code matching work in medical institutions? Answer 55: Manual code matching is a lot of work and inefficient. 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 location: 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 the use of medical institution users. When registering, they need to upload their medical institution practice license. 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: Using UDI service public welfare platform for code matching, essentially, the data of medical institutions are automatically mapped to the data of the 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 the manufacturer according to the information of the registration certificate of medical devices. 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 master database is the national UDI database, and the national Medical insurance classification and code master database is the National Medical Insurance Administration database. The construction subjects and data contents of the two databases are different. At present, there is no underlying mapping between the two databases. 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 encounter 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 can I query UDI policies and documents? Answer 60: 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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