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    Home > Medical News > Latest Medical News > In 2021, 69 UDI categories in 9 categories will be promoted globally

    In 2021, 69 UDI categories in 9 categories will be promoted globally

    • Last Update: 2021-03-22
    • Source: Internet
    • Author: User
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    Medical Network News on March 10th.
    Products cannot be registered and listed without using UDI.
    The product identification code has been linked to the registration of medical devices.
     
    Promote UDI globally in2021
     
    A few days ago, the Fujian Provincial Health Commission and the Fujian Provincial Medical Security Bureau issued the "Notice on Comprehensively Promoting the Construction of the Unique Identification System for Medical Devices.
    " "Medical Linkage" promotes the construction of UDI, adjusts and enriches the organization and leadership of the pilot work of the unique identification system for medical devices in Fujian Province, and adds a "four-code mapping group" on the basis of the four working groups of the UDI assistance group.
     
     
    The "Four Code Mapping Group" is mainly responsible for promoting the mapping of UDI codes with medical insurance codes, charge codes, and dictionary codes, expand the application research of UDI in medical, medical insurance, supervision and other fields, and explore the application mode of unique identification in procurement and settlement.
    , The promotion and application in customs, commerce, industry and information departments.
     
    According to tournament Bo blue instrument observation, since July 2019, Fujian Province, according to "the State Food and Drug Administration General Affairs Department of the National Health health notification Committee General Office programs to uniquely identify the pilot work on the issuance of Medical Devices" requirements, conduct of medical devices unique identification ( UDI) system pilot work.
     
    At present, the cooperative working group of the pilot work department of the unique identification system for medical devices in Fujian has evaluated the pilot work of the UDI system.
    Now the three municipal market supervision bureaus, namely Xiamen, Fuzhou, and Quanzhou, which have high enthusiasm and good pilot work, have been promoted.
    Bo Medical Technology Co.
    , Ltd.
    , Intech Innovation (Xiamen) Technology Co.
    , Ltd.
    , Xiamen Wantai Kerry Biotechnology Co.
    , Ltd.
    3 medical device manufacturers, Fujian National Medicine Equipment Co.
    , Ltd.
    , Fujian Youzhilian Medical Technology Co.
    , Ltd.
    2 Medical device operating companies;
     
      Four medical institutions, the Cardiovascular Hospital Affiliated to Xiamen University, Xiamen Hongai Hospital, Fuzhou Second Hospital, and Quanzhou Osteopathic Hospital, are listed as UDI pilot demonstration units in Fujian Province.
     
    69 varieties in   9 categories have landed
     
      In the field of production, the Food and Drug Administration of Fujian Province pointed out that the country’s first batch of 69 varieties of 9 categories of unique medical device identification has been officially implemented.
    Starting from January 1, 2021, enterprises involving such varieties in the province must All coded listings.
     
      According to the requirements of the State Food and Drug Administration, if the product identification (DI) is not filled in as required, the registration application materials will not be signed, which means that it is impossible to register for the market without using UDI products.
    Linking product identification codes to medical device registration is more urgent for medical device companies.
     
      Other enterprises with category III products in the province should upload the category III product identification (DI) to the National Bureau before July 1, 2021, and designate a commissioner to be responsible for the authenticity, accuracy and completeness of the data.
     
      From July 1, 2021, new applicants and re-registration class II medical device registrants should upload their product identification (DI) to the national medical device unique identification database, and complete the UDI code assignment before the product goes on sale.
     
      Encourage other listed Type II product manufacturers to complete the UDI code assignment as soon as possible.
     
      Medical device manufacturers should improve the quality of product codes, do a good job of scanning codes before finished products are put into storage, and prevent products with invalid codes from entering the market;
     
      At the same time, enterprises should fully consider the relevance of the smallest sales unit and smallest user unit (DI) in clinical use of the user organization based on the characteristics of their products, and improve the scientificity, rationality and convenience of terminal use in the design of the coding level.
     
      In the field of business, medical device distribution companies and medical device storage and delivery companies that purchase medical consumables in a centralized manner should scan all coded products to and from the warehouse before July 1, 2021.
    Do a good job in data connection with upstream and downstream units.
     
      The market supervision bureaus of districts and cities are responsible for supervising medical device distribution companies that purchase medical consumables in a large amount, and medical device storage and delivery companies to implement UDI system construction in the circulation link, and encourage other medical device companies to participate in the implementation of the UDI system as soon as possible And report to the Provincial Drug Administration by the end of July the implementation of UDI by medical device operating companies in the jurisdiction.
     
      The era of One-Code Unicom has arrived
     
      In the field of use, the Fujian Provincial Drug Administration, the Health Commission, and the Medical Insurance Bureau jointly promote the use of UDI in the field of use, promote the establishment of mapping relationships between UDI and "medical insurance code", "charge code" and "dictionary code", and a provincial-level sunshine procurement platform Improve platform data UDI identification according to the mapping situation.
     
      Health departments and market supervision bureaus at all levels shall jointly supervise the corresponding level of medical institutions to strengthen the construction of their own information system, and use UDI to achieve refined management of medical devices .
     
      UDI pilot demonstration medical institutions that have implemented UDI scan code analysis and other aspects of in-hospital storage, delivery, consumption, etc.
    , will complete UDI codes and "medical insurance codes", "charge codes" and "dictionary codes" before July 1, 2021.
    ”Mapping to realize the “one-code connection” of UDI code.
     
      UDI pilot medical institutions should realize the analysis and application of UDI codes for all products with UDI codes before September 30, 2021, actively promote the full scanning and transfer of UDI coded medical devices in the hospital, and promote the use of UDI to realize medical devices.
    Refined management.
     
      UDI pilot medical institutions will no longer accept products without UDI codes produced after January 1, 2021, in 69 categories listed in the "Announcement on Deepening the Pilot Program and Implementing the First Batch of Implementation of the Unique Identification of Medical Devices", but Products without UDI code produced before this date should not be rejected.
     
      The Food and Drug Administration of Fujian Province pointed out that other medical institutions should actively promote UDI work in accordance with the "Guidelines for the Implementation of UDI for Medical Institutions" and use UDI to achieve refined management of medical devices.
    After the national unified national medical insurance code is implemented, all units should do a good job of mapping the UDI code and the national medical insurance code in a timely manner.
     
      Unique Device Identification (UDI) is composed of product identification (DI) and production identification (PI).
    It is a uniform and effective coding system for medical devices, which can be easily understood as "medical device ID card".
     
      The unique identification of medical devices is the "ID card" of medical devices, which is the basis for unique and accurate identification of medical devices.
    It runs through the production, circulation and use of medical devices, and will affect the entire life cycle of medical devices.
     
      What does the medical device "ID card" look like? What do each part represent?
     
      
      (Image source: Zhejiang News Client)
     
      According to the company's introduction, the "ID card" is similar to the barcode of the commodity.
    It consists of two parts.
    The first part is the basic information of the company, including packaging information, and the second part is mainly the dynamic information of the company's production.
    The code can realize the whole process.
    The management of the hospital can ultimately be linked to the hospital ’s electronic medical records.
     
    The first batch of product catalogs with unique identification of medical devices
      Medical Network News on March 10th.
    Products cannot be registered and listed without using UDI.
    The product identification code has been linked to the registration of medical devices.
     
    Promote UDI globally in   2021
     
      A few days ago, the Fujian Provincial Health Commission and the Fujian Provincial Medical Security Bureau issued the "Notice on Comprehensively Promoting the Construction of the Unique Identification System for Medical Devices.
    " "Medical Linkage" promotes the construction of UDI, adjusts and enriches the organization and leadership of the pilot work of the unique identification system for medical devices in Fujian Province, and adds a "four-code mapping group" on the basis of the four working groups of the UDI assistance group.
     
     
       The "Four Code Mapping Group" is mainly responsible for promoting the mapping of UDI codes with medical insurance codes, charge codes, and dictionary codes, expand the application research of UDI in medical, medical insurance, supervision and other fields, and explore the application mode of unique identification in procurement and settlement.
    , The promotion and application in customs, commerce, industry and information departments.
     
      According to tournament Bo blue instrument observation, since July 2019, Fujian Province, according to "the State Food and Drug Administration General Affairs Department of the National Health health notification Committee General Office programs to uniquely identify the pilot work on the issuance of Medical Devices" requirements, conduct of medical devices unique identification ( UDI) system pilot work.
     
      At present, the cooperative working group of the pilot work department of the unique identification system for medical devices in Fujian has evaluated the pilot work of the UDI system.
    Now the three municipal market supervision bureaus, namely Xiamen, Fuzhou, and Quanzhou, which have high enthusiasm and good pilot work, have been promoted.
    Bo Medical Technology Co.
    , Ltd.
    , Intech Innovation (Xiamen) Technology Co.
    , Ltd.
    , Xiamen Wantai Kerry Biotechnology Co.
    , Ltd.
    3 medical device manufacturers, Fujian National Medicine Equipment Co.
    , Ltd.
    , Fujian Youzhilian Medical Technology Co.
    , Ltd.
    2 Medical device operating companies;
     
      Four medical institutions, the Cardiovascular Hospital Affiliated to Xiamen University, Xiamen Hongai Hospital, Fuzhou Second Hospital, and Quanzhou Osteopathic Hospital, are listed as UDI pilot demonstration units in Fujian Province.
     
    69 varieties in   9 categories have landed
     
      In the field of production, the Food and Drug Administration of Fujian Province pointed out that the country’s first batch of 69 varieties of 9 categories of unique medical device identification has been officially implemented.
    Starting from January 1, 2021, enterprises involving such varieties in the province must All coded listings.
     
      According to the requirements of the State Food and Drug Administration, if the product identification (DI) is not filled in as required, the registration application materials will not be signed, which means that it is impossible to register for the market without using UDI products.
    Linking product identification codes to medical device registration is more urgent for medical device companies.
     
      Other enterprises with category III products in the province should upload the category III product identification (DI) to the National Bureau before July 1, 2021, and designate a commissioner to be responsible for the authenticity, accuracy and completeness of the data.
     
      From July 1, 2021, new applicants and re-registration class II medical device registrants should upload their product identification (DI) to the national medical device unique identification database, and complete the UDI code assignment before the product goes on sale.
     
      Encourage other listed Type II product manufacturers to complete the UDI code assignment as soon as possible.
     
      Medical device manufacturers should improve the quality of product codes, do a good job of scanning codes before finished products are put into storage, and prevent products with invalid codes from entering the market;
     
      At the same time, enterprises should fully consider the relevance of the smallest sales unit and smallest user unit (DI) in clinical use of the user organization based on the characteristics of their products, and improve the scientificity, rationality and convenience of terminal use in the design of the coding level.
     
      In the field of business, medical device distribution companies and medical device storage and delivery companies that purchase medical consumables in a centralized manner should scan all coded products to and from the warehouse before July 1, 2021.
    Do a good job in data connection with upstream and downstream units.
     
      The market supervision bureaus of districts and cities are responsible for supervising medical device distribution companies that purchase medical consumables in a large amount, and medical device storage and delivery companies to implement UDI system construction in the circulation link, and encourage other medical device companies to participate in the implementation of the UDI system as soon as possible And report to the Provincial Drug Administration by the end of July the implementation of UDI by medical device operating companies in the jurisdiction.
     
      The era of One-Code Unicom has arrived
     
      In the field of use, the Fujian Provincial Drug Administration, the Health Commission, and the Medical Insurance Bureau jointly promote the use of UDI in the field of use, promote the establishment of mapping relationships between UDI and "medical insurance code", "charge code" and "dictionary code", and a provincial-level sunshine procurement platform Improve platform data UDI identification according to the mapping situation.
     
      Health departments and market supervision bureaus at all levels shall jointly supervise the corresponding level of medical institutions to strengthen the construction of their own information system, and use UDI to achieve refined management of medical devices .
     
      UDI pilot demonstration medical institutions that have implemented UDI scan code analysis and other aspects of in-hospital storage, delivery, consumption, etc.
    , will complete UDI codes and "medical insurance codes", "charge codes" and "dictionary codes" before July 1, 2021.
    ”Mapping to realize the “one-code connection” of UDI code.
     
      UDI pilot medical institutions should realize the analysis and application of UDI codes for all products with UDI codes before September 30, 2021, actively promote the full scanning and transfer of UDI coded medical devices in the hospital, and promote the use of UDI to realize medical devices.
    Refined management.
     
      UDI pilot medical institutions will no longer accept products without UDI codes produced after January 1, 2021, in 69 categories listed in the "Announcement on Deepening the Pilot Program and Implementing the First Batch of Implementation of the Unique Identification of Medical Devices", but Products without UDI code produced before this date should not be rejected.
     
      The Food and Drug Administration of Fujian Province pointed out that other medical institutions should actively promote UDI work in accordance with the "Guidelines for the Implementation of UDI for Medical Institutions" and use UDI to achieve refined management of medical devices.
    After the national unified national medical insurance code is implemented, all units should do a good job of mapping the UDI code and the national medical insurance code in a timely manner.
     
      Unique Device Identification (UDI) is composed of product identification (DI) and production identification (PI).
    It is a uniform and effective coding system for medical devices, which can be easily understood as "medical device ID card".
     
      The unique identification of medical devices is the "ID card" of medical devices, which is the basis for unique and accurate identification of medical devices.
    It runs through the production, circulation and use of medical devices, and will affect the entire life cycle of medical devices.
     
      What does the medical device "ID card" look like? What do each part represent?
     
      
      (Image source: Zhejiang News Client)
     
      According to the company's introduction, the "ID card" is similar to the barcode of the commodity.
    It consists of two parts.
    The first part is the basic information of the company, including packaging information, and the second part is mainly the dynamic information of the company's production.
    The code can realize the whole process.
    The management of the hospital can ultimately be linked to the hospital ’s electronic medical records.
     
    The first batch of product catalogs with unique identification of medical devices
      Medical Network News on March 10th.
    Products cannot be registered and listed without using UDI.
    The product identification code has been linked to the registration of medical devices.
     
    Promote UDI globally in   2021
    Promote UDI globally in   2021
     
      A few days ago, the Fujian Provincial Health Commission and the Fujian Provincial Medical Security Bureau issued the "Notice on Comprehensively Promoting the Construction of the Unique Identification System for Medical Devices.
    " "Medical Linkage" promotes the construction of UDI, adjusts and enriches the organization and leadership of the pilot work of the unique identification system for medical devices in Fujian Province, and adds a "four-code mapping group" on the basis of the four working groups of the UDI assistance group.
     
     
       The "Four Code Mapping Group" is mainly responsible for promoting the mapping of UDI codes with medical insurance codes, charge codes, and dictionary codes, expand the application research of UDI in medical, medical insurance, supervision and other fields, and explore the application mode of unique identification in procurement and settlement.
    , The promotion and application in customs, commerce, industry and information departments.
     
      According to tournament Bo blue instrument observation, since July 2019, Fujian Province, according to "the State Food and Drug Administration General Affairs Department of the National Health health notification Committee General Office programs to uniquely identify the pilot work on the issuance of Medical Devices" requirements, conduct of medical devices unique identification ( UDI) system pilot work.
    Healthy, healthy, healthy
     
      At present, the cooperative working group of the pilot work department of the unique identification system for medical devices in Fujian has evaluated the pilot work of the UDI system.
    Now the three municipal market supervision bureaus, namely Xiamen, Fuzhou, and Quanzhou, which have high enthusiasm and good pilot work, have been promoted.
    Bo Medical Technology Co.
    , Ltd.
    , Intech Innovation (Xiamen) Technology Co.
    , Ltd.
    , Xiamen Wantai Kerry Biotechnology Co.
    , Ltd.
    3 medical device manufacturers, Fujian National Medicine Equipment Co.
    , Ltd.
    , Fujian Youzhilian Medical Technology Co.
    , Ltd.
    2 Medical device operating companies;
     
      Four medical institutions, the Cardiovascular Hospital Affiliated to Xiamen University, Xiamen Hongai Hospital, Fuzhou Second Hospital, and Quanzhou Osteopathic Hospital, are listed as UDI pilot demonstration units in Fujian Province.
     
    69 varieties in   9 categories have landed
    69 varieties in   9 categories have landed
     
      In the field of production, the Food and Drug Administration of Fujian Province pointed out that the country’s first batch of 69 varieties of 9 categories of unique medical device identification has been officially implemented.
    Starting from January 1, 2021, enterprises involving such varieties in the province must All coded listings.
     
      According to the requirements of the State Food and Drug Administration, if the product identification (DI) is not filled in as required, the registration application materials will not be signed, which means that it is impossible to register for the market without using UDI products.
    Linking product identification codes to medical device registration is more urgent for medical device companies.
     
      Other enterprises with category III products in the province should upload the category III product identification (DI) to the National Bureau before July 1, 2021, and designate a commissioner to be responsible for the authenticity, accuracy and completeness of the data.
     
      From July 1, 2021, new applicants and re-registration class II medical device registrants should upload their product identification (DI) to the national medical device unique identification database, and complete the UDI code assignment before the product goes on sale.
     
      Encourage other listed Type II product manufacturers to complete the UDI code assignment as soon as possible.
     
      Medical device manufacturers should improve the quality of product codes, do a good job of scanning codes before finished products are put into storage, and prevent products with invalid codes from entering the market;
     
      At the same time, enterprises should fully consider the relevance of the smallest sales unit and smallest user unit (DI) in clinical use of the user organization based on the characteristics of their products, and improve the scientificity, rationality and convenience of terminal use in the design of the coding level.
     
      In the field of business, medical device distribution companies and medical device storage and delivery companies that purchase medical consumables in a centralized manner should scan all coded products to and from the warehouse before July 1, 2021.
    Do a good job in data connection with upstream and downstream units.
     
      The market supervision bureaus of districts and cities are responsible for supervising medical device distribution companies that purchase medical consumables in a large amount, and medical device storage and delivery companies to implement UDI system construction in the circulation link, and encourage other medical device companies to participate in the implementation of the UDI system as soon as possible And report to the Provincial Drug Administration by the end of July the implementation of UDI by medical device operating companies in the jurisdiction.
     
      The era of One-Code Unicom has arrived
      The era of One-Code Unicom has arrived
     
      In the field of use, the Fujian Provincial Drug Administration, the Health Commission, and the Medical Insurance Bureau jointly promote the use of UDI in the field of use, promote the establishment of mapping relationships between UDI and "medical insurance code", "charge code" and "dictionary code", and a provincial-level sunshine procurement platform Improve platform data UDI identification according to the mapping situation.
    Medicine, medicine, medicine
     
      Health departments and market supervision bureaus at all levels shall jointly supervise the corresponding level of medical institutions to strengthen the construction of their own information system, and use UDI to achieve refined management of medical devices .
    Medical equipment medical equipment medical equipment
     
      UDI pilot demonstration medical institutions that have implemented UDI scan code analysis and other aspects of in-hospital storage, delivery, consumption, etc.
    , will complete UDI codes and "medical insurance codes", "charge codes" and "dictionary codes" before July 1, 2021.
    ”Mapping to realize the “one-code connection” of UDI code.
     
      UDI pilot medical institutions should realize the analysis and application of UDI codes for all products with UDI codes before September 30, 2021, actively promote the full scanning and transfer of UDI coded medical devices in the hospital, and promote the use of UDI to realize medical devices.
    Refined management.
     
      UDI pilot medical institutions will no longer accept products without UDI codes produced after January 1, 2021, in 69 categories listed in the "Announcement on Deepening the Pilot Program and Implementing the First Batch of Implementation of the Unique Identification of Medical Devices", but Products without UDI code produced before this date should not be rejected.
     
      The Food and Drug Administration of Fujian Province pointed out that other medical institutions should actively promote UDI work in accordance with the "Guidelines for the Implementation of UDI for Medical Institutions" and use UDI to achieve refined management of medical devices.
    After the national unified national medical insurance code is implemented, all units should do a good job of mapping the UDI code and the national medical insurance code in a timely manner.
     
      Unique Device Identification (UDI) is composed of product identification (DI) and production identification (PI).
    It is a uniform and effective coding system for medical devices, which can be easily understood as "medical device ID card".
     
      The unique identification of medical devices is the "ID card" of medical devices, which is the basis for unique and accurate identification of medical devices.
    It runs through the production, circulation and use of medical devices, and will affect the entire life cycle of medical devices.
     
      What does the medical device "ID card" look like? What do each part represent?
     
      
      (Image source: Zhejiang News Client)
     
      According to the company's introduction, the "ID card" is similar to the barcode of the commodity.
    It consists of two parts.
    The first part is the basic information of the company, including packaging information, and the second part is mainly the dynamic information of the company's production.
    The code can realize the whole process.
    The management of the hospital can ultimately be linked to the hospital ’s electronic medical records.
    Enterprise Enterprise Enterprise Hospital Hospital Hospital
     
    The first batch of product catalogs with unique identification of medical devices
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