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    Home > Medical News > Latest Medical News > Background interpretation of the current round of revision of the Regulations on the Supervision and Administration of Medical Devices

    Background interpretation of the current round of revision of the Regulations on the Supervision and Administration of Medical Devices

    • Last Update: 2021-03-23
    • Source: Internet
    • Author: User
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      2.
    Optimize and speed up the listing system of medical devices.
    The continuous implementation of various system designs has promoted the innovation and development of medical devices.
    For example, since the "green channel" of medical device review and approval opened in the "Innovative Medical Device Special Review Procedure", innovative medical devices that have been approved for marketing are concentrated in the interventional, The quantity and quality of high-end medical equipment such as high-end medical imaging equipment have been improved.
    The 2009 "Medical Device Emergency Approval Procedure" played a positive role in accelerating the listing of anti-epidemic medical devices during the epidemic.
    In 2020, in accordance with the priority medical device approval process, 15 medical devices including genetic testing kits for hereditary deafness will be approved for marketing.
    This series of systems need to be optimized and fixed at the
    pharmnet.
    com.
    cn/" target="_blank">legal
    level.
     
      3.
    Optimize the management model of clinical evaluation of medical devices.
    The clinical evaluation of medical devices refers to the process by which the applicant confirms whether the product meets the scope of clinical application and use requirements through clinical
    literature , clinical experience data, clinical trials and other information.
    The current medical device regulations stipulate that the medical device must be submitted for clinical registration or filing.
    Evaluation data.
    Clinical trials are the most demanding method in clinical evaluation.
    At present, it is stipulated that some products in the catalog of exempt clinical trials can be used for clinical evaluation in other ways.
    The draft of the "Regulations on the Supervision and Administration of Medical Devices" published in 2018 stipulates that the first category of medical device products does not require clinical evaluation; in principle, the application for the second category of medical device product registration does not require clinical evaluation; application of the third category For the registration of similar medical device products, clinical evaluation shall be conducted, but those that meet the requirements may be exempted from clinical evaluation.
    This will be an important change in the clinical evaluation of medical device registration and marketing.
     
      Background 3: Increase the punishment for violations to ensure the quality and safety of medical devices
     
      This round of revisions will strictly implement the "four most stringent" requirements, increase penalties for violations, and substantially increase the amount of fines for serious violations involving quality and safety.
    According to the draft, there will be a fine of up to 30 times the value of the goods.
    .
    We will further improve the system of penalizing individuals, imposing fines on individuals, and implementing penalties such as industry and market bans.
     
      In general, this round of revision is based on a deep understanding of the new situation facing the current medical device supervision work and speeding up the new requirements for the leap from a major manufacturing country to a strong manufacturing country, combined with new development stages, new development concepts, etc.
    The opportunities and challenges brought by device supervision are fundamentally followed by the “four strictest” requirements, keeping the bottom line to ensure safety, chasing the top line to promote development, deepening the reform and innovation of medical device supervision, and advancing the quality supervision of the whole life cycle of medical devices.
     
       (The author of this article is the Secretary-General of Shanghai Food and Drug Safety Research Association)
      Medical Network, March 4th, medical equipment is related to the health and life safety of the people, and strict supervision must be implemented.
    Since the State Council first issued the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") on January 4, 2000, the legal system for the registration, production, operation, and use of medical devices formed around the "Regulations" is the guarantee for the development of the medical device industry .
    With the continuous revision and adjustment of the industry development, reviewing its revision history, it has successively undergone large-scale revisions in 2014 and revisions in 2017 for clinical trial management, large-scale medical equipment configuration, and purchase inspection obligations of operating companies.
     
      On December 21, 2020, the State Council executive meeting reviewed and approved the "Regulations on the Supervision and Administration of Medical Devices (Revision Draft)" (hereinafter referred to as the "Regulations Revision").
    The "Regulations Amendment" has made substantial amendments in terms of strengthening the main responsibility of enterprises, adding the traceability of the unique product identification, and increasing the penalties for violations.
     
      Analyzing the background of the issuance of the "Regulation Amendment", we can see the following characteristics:
     
      Background 1: The rapid development of the medical device industry and the improvement of regulatory concepts and methods
     
      Medical devices have experienced explosive growth in the past 20 years.
    Medical device manufacturers have grown from more than 8,000 to more than 25,000.
    The scale of the industry has continued to increase, and the product categories have been continuously enriched.
     
      Since 2014, the compound growth rate of the domestic medical device market has been around 20%, much higher than the global growth rate.
    The year-on-year growth rate of total sales has remained above 15%, showing that China's medical device industry is in a stage of continuous expansion.
     
      Especially since 2020, the new crown epidemic has broken out on a global scale, and medical devices for protection and emergency treatment have become urgently needed anti-epidemic items, and global demand has increased significantly.
    The entry of many non-medical device industry enterprises and personnel into the medical device industry has brought new challenges to management.
    It is necessary to establish the concept of scientific supervision and match the supervision force according to the level of risk.
    For example, through the addition of the requirement for the traceability of the unique product identification, the supervision efficiency can be improved.
     
      Background 2: Review and approve reforms to activate innovation momentum, and to revise regulations and fix pilot experience
     
      In 2017, the "Two Offices" "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices " and other documents made the top-level design of the reform of the medical device review and approval system, from clinical trial management, medical device life cycle management responsibilities, Detailed plans have been made in the system and other aspects, and this round of revision will further fix these plans.
     
      1.
    The results of the pilot program for the registrant system of fixed medical devices.
    In December 2017, the "Implementation Plan for the Pilot Work of the Medical Device Registrant System in the China (Shanghai) Pilot Free Trade Zone" was issued and implemented by the Shanghai Food and Drug Administration.
    It was the first to pilot the medical device registrant system in the Shanghai Free Trade Zone.
    Applicants for medical device registration can separately apply for a medical device registration certificate, and then entrust the production to a qualified and capable production
    enterprise .
    In August 2019, the "Notice of the State Food and Drug Administration on Expanding the Pilot Work of the Medical Device Registrant System" expanded the pilot to Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Jiangsu, Zhejiang and other provinces and cities.
    There are similarities and differences in the pilot programs in various regions.
    In this round of revision, the medical device registrant system will absorb the experience accumulated in the pilot programs in various regions to complete its top-level plan as a basic system.
     
      The "Regulations Amendment" clearly indicates that the holder of the medical device registration certificate is the medical device registrant, and the registrant bears the full life cycle legal responsibility for the design and development, clinical trials, manufacturing, sales and distribution, and adverse event reports of medical devices; The requirements and scope of responsibilities of entrusted R&D, clinical trials, manufacturing and other entities will also be further clarified.
     
      2.
    Optimize and speed up the listing system of medical devices.
    The continuous implementation of various system designs has promoted the innovation and development of medical devices.
    For example, since the "green channel" of medical device review and approval opened in the "Innovative Medical Device Special Review Procedure", innovative medical devices that have been approved for marketing are concentrated in the interventional, The quantity and quality of high-end medical equipment such as high-end medical imaging equipment have been improved.
    The 2009 "Medical Device Emergency Approval Procedure" played a positive role in accelerating the listing of anti-epidemic medical devices during the epidemic.
    In 2020, in accordance with the priority medical device approval process, 15 medical devices including genetic testing kits for hereditary deafness will be approved for marketing.
    This series of systems need to be optimized and fixed at the
    pharmnet.
    com.
    cn/" target="_blank">legal
    level.
     
      3.
    Optimize the management model of clinical evaluation of medical devices.
    The clinical evaluation of medical devices refers to the process by which the applicant confirms whether the product meets the scope of clinical application and use requirements through clinical
    literature , clinical experience data, clinical trials and other information.
    The current medical device regulations stipulate that the medical device must be submitted for clinical registration or filing.
    Evaluation data.
    Clinical trials are the most demanding method in clinical evaluation.
    At present, it is stipulated that some products in the catalog of exempt clinical trials can be used for clinical evaluation in other ways.
    The draft of the "Regulations on the Supervision and Administration of Medical Devices" published in 2018 stipulates that the first category of medical device products does not require clinical evaluation; in principle, the application for the second category of medical device product registration does not require clinical evaluation; application of the third category For the registration of similar medical device products, clinical evaluation shall be conducted, but those that meet the requirements may be exempted from clinical evaluation.
    This will be an important change in the clinical evaluation of medical device registration and marketing.
     
      Background 3: Increase the punishment for violations to ensure the quality and safety of medical devices
     
      This round of revisions will strictly implement the "four most stringent" requirements, increase penalties for violations, and substantially increase the amount of fines for serious violations involving quality and safety.
    According to the draft, there will be a fine of up to 30 times the value of the goods.
    .
    We will further improve the system of penalizing individuals, imposing fines on individuals, and implementing penalties such as industry and market bans.
     
      In general, this round of revision is based on a deep understanding of the new situation facing the current medical device supervision work and speeding up the new requirements for the leap from a major manufacturing country to a strong manufacturing country, combined with new development stages, new development concepts, etc.
    The opportunities and challenges brought by device supervision are fundamentally followed by the “four strictest” requirements, keeping the bottom line to ensure safety, chasing the top line to promote development, deepening the reform and innovation of medical device supervision, and advancing the quality supervision of the whole life cycle of medical devices.
     
       (The author of this article is the Secretary-General of Shanghai Food and Drug Safety Research Association)
      Medical Network, March 4th, medical equipment is related to the health and life safety of the people, and strict supervision must be implemented.
    Since the State Council first issued the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") on January 4, 2000, the legal system for the registration, production, operation, and use of medical devices formed around the "Regulations" is the guarantee for the development of the medical device industry .
    With the continuous revision and adjustment of the industry development, reviewing its revision history, it has successively undergone large-scale revisions in 2014 and revisions in 2017 for clinical trial management, large-scale medical equipment configuration, and purchase inspection obligations of operating companies.
     
      On December 21, 2020, the State Council executive meeting reviewed and approved the "Regulations on the Supervision and Administration of Medical Devices (Revision Draft)" (hereinafter referred to as the "Regulations Revision").
    The "Regulations Amendment" has made substantial amendments in terms of strengthening the main responsibility of enterprises, adding the traceability of the unique product identification, and increasing the penalties for violations.
     
      Analyzing the background of the issuance of the "Regulation Amendment", we can see the following characteristics:
     
      Background 1: The rapid development of the medical device industry and the improvement of regulatory concepts and methods
      Background 1: The rapid development of the medical device industry and the improvement of regulatory concepts and methods
     
      Medical devices have experienced explosive growth in the past 20 years.
    Medical device manufacturers have grown from more than 8,000 to more than 25,000.
    The scale of the industry has continued to increase, and the product categories have been continuously enriched.
     
      Since 2014, the compound growth rate of the domestic medical device market has been around 20%, much higher than the global growth rate.
    The year-on-year growth rate of total sales has remained above 15%, showing that China's medical device industry is in a stage of continuous expansion.
     
      Especially since 2020, the new crown epidemic has broken out on a global scale, and medical devices for protection and emergency treatment have become urgently needed anti-epidemic items, and global demand has increased significantly.
    The entry of many non-medical device industry enterprises and personnel into the medical device industry has brought new challenges to management.
    It is necessary to establish the concept of scientific supervision and match the supervision force according to the level of risk.
    For example, through the addition of the requirement for the traceability of the unique product identification, the supervision efficiency can be improved.
     
      Background 2: Review and approve reforms to activate innovation momentum, and to revise regulations and fix pilot experience
      Background 2: Review and approve reforms to activate innovation momentum, and to revise regulations and fix pilot experience
     
      In 2017, the "Two Offices" "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices " and other documents made the top-level design of the reform of the medical device review and approval system, from clinical trial management, medical device life cycle management responsibilities, Detailed plans have been made in the system and other aspects, and this round of revision will further fix these plans.
    Drugs medical equipment medicines medicines Medical Devices Medical Devices
     
      1.
    The results of the pilot program for the registrant system of fixed medical devices.
    In December 2017, the "Implementation Plan for the Pilot Work of the Medical Device Registrant System in the China (Shanghai) Pilot Free Trade Zone" was issued and implemented by the Shanghai Food and Drug Administration.
    It was the first to pilot the medical device registrant system in the Shanghai Free Trade Zone.
    Applicants for medical device registration can separately apply for a medical device registration certificate, and then entrust the production to a qualified and capable production
    enterprise .
    In August 2019, the "Notice of the State Food and Drug Administration on Expanding the Pilot Work of the Medical Device Registrant System" expanded the pilot to Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Jiangsu, Zhejiang and other provinces and cities.
    There are similarities and differences in the pilot programs in various regions.
    In this round of revision, the medical device registrant system will absorb the experience accumulated in the pilot programs in various regions to complete its top-level plan as a basic system.
    Enterprise business enterprise
     
      The "Regulations Amendment" clearly indicates that the holder of the medical device registration certificate is the medical device registrant, and the registrant bears the full life cycle legal responsibility for the design and development, clinical trials, manufacturing, sales and distribution, and adverse event reports of medical devices; The requirements and scope of responsibilities of entrusted R&D, clinical trials, manufacturing and other entities will also be further clarified.
     
      2.
    Optimize and speed up the listing system of medical devices.
    The continuous implementation of various system designs has promoted the innovation and development of medical devices.
    For example, since the "green channel" of medical device review and approval opened in the "Innovative Medical Device Special Review Procedure", innovative medical devices that have been approved for marketing are concentrated in the interventional, The quantity and quality of high-end medical equipment such as high-end medical imaging equipment have been improved.
    The 2009 "Medical Device Emergency Approval Procedure" played a positive role in accelerating the listing of anti-epidemic medical devices during the epidemic.
    In 2020, in accordance with the priority medical device approval process, 15 medical devices including genetic testing kits for hereditary deafness will be approved for marketing.
    This series of systems need to be optimized and fixed at the
    pharmnet.
    com.
    cn/" target="_blank">legal
    level.
    pharmnet.
    com.
    cn/" target="_blank">Regulations
    pharmnet.
    com.
    cn/" target="_blank"> and regulations
     
      3.
    Optimize the management model of clinical evaluation of medical devices.
    The clinical evaluation of medical devices refers to the process by which the applicant confirms whether the product meets the scope of clinical application and use requirements through clinical
    literature , clinical experience data, clinical trials and other information.
    The current medical device regulations stipulate that the medical device must be submitted for clinical registration or filing.
    Evaluation data.
    Clinical trials are the most demanding method in clinical evaluation.
    At present, it is stipulated that some products in the catalog of exempt clinical trials can be used for clinical evaluation in other ways.
    The draft of the "Regulations on the Supervision and Administration of Medical Devices" published in 2018 stipulates that the first category of medical device products does not require clinical evaluation; in principle, the application for the second category of medical device product registration does not require clinical evaluation; application of the third category For the registration of similar medical device products, clinical evaluation shall be conducted, but those that meet the requirements may be exempted from clinical evaluation.
    This will be an important change in the clinical evaluation of medical device registration and marketing.
    Literature literature literature
     
      Background 3: Increase the punishment for violations to ensure the quality and safety of medical devices
      Background 3: Increase the punishment for violations to ensure the quality and safety of medical devices
     
      This round of revisions will strictly implement the "four most stringent" requirements, increase penalties for violations, and substantially increase the amount of fines for serious violations involving quality and safety.
    According to the draft, there will be a fine of up to 30 times the value of the goods.
    .
    We will further improve the system of penalizing individuals, imposing fines on individuals, and implementing penalties such as industry and market bans.
     
      In general, this round of revision is based on a deep understanding of the new situation facing the current medical device supervision work and speeding up the new requirements for the leap from a major manufacturing country to a strong manufacturing country, combined with new development stages, new development concepts, etc.
    The opportunities and challenges brought by device supervision are fundamentally followed by the “four strictest” requirements, keeping the bottom line to ensure safety, chasing the top line to promote development, deepening the reform and innovation of medical device supervision, and advancing the quality supervision of the whole life cycle of medical devices.
     
       (The author of this article is the Secretary-General of Shanghai Food and Drug Safety Research Association)
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.
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