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Medical News, April 1st, Medical News, April 1st
All cities involved
On March 30, the National Medical Products Administration and the National Standardization Administration issued the "Opinions on Further Promoting the High-Quality Development of Medical Device Standardization".
The document requires the market supervision bureaus (departments and commissions of the Xinjiang Production and Construction Corps) of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps.
), Food and Drug Administration, national professional standardization technical committees and sub-technical committees in various medical device fields, various medical device standardization technical centralized units, and all relevant units to implement.
The document requires the market supervision bureaus (departments and commissions of the Xinjiang Production and Construction Corps) of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps.
), Food and Drug Administration, national professional standardization technical committees and sub-technical committees in various medical device fields, various medical device standardization technical centralized units, and all relevant units to implement.
The key points of Cyber Blue Equipment are as follows:
▍Key 1: By 2025, my country will basically establish a full life cycle system for medical devices
The document points out that by 2025, it will be basically completed to meet the needs of my country's medical device development, production, operation, use, supervision and management and other life-cycle management needs, meet the new requirements of strict safety bottom line and boost quality, and be in line with international standards and have Chinese characteristics.
, Scientific and advanced medical device standard system, realize the comprehensive improvement of standard quality, higher quality, timely and diversified standard supply, more complete, efficient and coordinated standard management, and deeper and more effective standard international exchanges and cooperation.
, Scientific and advanced medical device standard system, realize the comprehensive improvement of standard quality, higher quality, timely and diversified standard supply, more complete, efficient and coordinated standard management, and deeper and more effective standard international exchanges and cooperation.
▍Key 2: Comprehensive evaluation of mandatory medical device standards
Research and formulate general principles and basic requirements for the construction of the standard system, rationally plan the layout of the standard system, and scientifically formulate standard plans around the major deployment of medical device supervision and industrial development.
Implement the statistical analysis and reporting system for the implementation of mandatory national standards, comprehensively carry out mandatory standard assessments, continue to optimize the mandatory standards for medical devices, strictly limit the scope of mandatory standard formulation, and gradually transform mandatory industry standards with a wide range of applications and great influence It is a mandatory national standard.
Implement the statistical analysis and reporting system for the implementation of mandatory national standards, comprehensively carry out mandatory standard assessments, continue to optimize the mandatory standards for medical devices, strictly limit the scope of mandatory standard formulation, and gradually transform mandatory industry standards with a wide range of applications and great influence It is a mandatory national standard.
▍Key 3: Encourage the development and revision of recommended industry standards in emerging technology fields and urgently needed by supervision
Optimizing recommended standards, focusing on supporting the formulation and revision of recommended national standards that are basic and common, supporting compulsory national standards, and leading the industry; encourage the formulation and revision of recommended industry standards in emerging technology fields and urgently needed by supervision.
Cultivate the development of group standards and encourage social groups to actively develop group standards in the field of medical devices around new technologies and new business formats.
Establish a medical device standard system with reasonable structure, clear levels, coordinated and supporting facilities, keeping the bottom line to ensure safety, and chasing the top line to promote development.
Cultivate the development of group standards and encourage social groups to actively develop group standards in the field of medical devices around new technologies and new business formats.
Establish a medical device standard system with reasonable structure, clear levels, coordinated and supporting facilities, keeping the bottom line to ensure safety, and chasing the top line to promote development.
Improve medical device terminology definitions, marking and identification, risk management, quality management, clinical evaluation management, usability engineering, statistical technology, digital security and other basic standards covering the entire life cycle of medical devices.
Speed up the formulation and revision of general standards for basic safety and basic performance, biological evaluation of medical electrical equipment.
Speed up the formulation and revision of general standards for basic safety and basic performance, biological evaluation of medical electrical equipment.
▍Key 4: Active medical devices will focus on
Strengthen the development of active medical device standards.
Accelerate the advancement of common technology research and standard formulation of medical equipment in emerging fields such as medical robots, artificial intelligence, active implants, medical software, 5G+ industrial Internet, and multi-technology integration.
Explore and promote the formulation of standards for key core components of medical devices.
Accelerate the advancement of common technology research and standard formulation of medical equipment in emerging fields such as medical robots, artificial intelligence, active implants, medical software, 5G+ industrial Internet, and multi-technology integration.
Explore and promote the formulation of standards for key core components of medical devices.
Improve medical respiratory and anesthesia equipment, disinfection and sterilization equipment, oral digital equipment, medical body circulation equipment, radiotherapy and nuclear medicine equipment, medical ultrasound equipment, physical therapy equipment, medical laboratory equipment, medical X-ray diagnostic equipment, and medical laser equipment , Medical radio frequency equipment and other high-end medical equipment related standards.
▍Key 5: Strengthen the development of passive medical device standards
Strengthen the development of standards for passive medical devices.
Strengthen the research of new biomedical material standards, and promote the formulation and revision of new technologies, new processes, and new materials standards for drug-device combination products, additive manufacturing, biodegradable products, tissue engineering products, recombinant collagen products, and nanometer products.
Carry out research on hazardous substance characterization and toxicological evaluation methods and standard formulation.
Strengthen the research of new biomedical material standards, and promote the formulation and revision of new technologies, new processes, and new materials standards for drug-device combination products, additive manufacturing, biodegradable products, tissue engineering products, recombinant collagen products, and nanometer products.
Carry out research on hazardous substance characterization and toxicological evaluation methods and standard formulation.
Establish a standard system for preclinical animal testing.
Intensify the standardization of new products such as passive implants, medical dressings, biological protective equipment, dental equipment, and optics.
Intensify the standardization of new products such as passive implants, medical dressings, biological protective equipment, dental equipment, and optics.
▍Key 6: Strengthen the development of in vitro diagnostic reagent standards
Accelerate the development of standards for diagnostic reagents and related methods for high-risk infectious diseases, and carry out research on in vitro diagnostic reagent standards related to the prevention and control of the new crown pneumonia epidemic.
Promote the formulation and revision of standards in the fields of high-throughput sequencing and other new molecular diagnostic technologies, clinical mass spectrometry technologies, companion diagnostic reagents, point-of-care testing, traceability and reference measurement systems.
Promote the formulation and revision of standards in the fields of high-throughput sequencing and other new molecular diagnostic technologies, clinical mass spectrometry technologies, companion diagnostic reagents, point-of-care testing, traceability and reference measurement systems.
The new "Regulations" will be formally implemented soon
A few days ago, the State Council Information Office held a regular policy briefing to introduce the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations").
Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Drug Administration, attended the briefing and answered questions from reporters.
Xu Jinghe pointed out that the revision of the "Regulations" fully implemented the "four strictest" requirements.
Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Drug Administration, attended the briefing and answered questions from reporters.
Xu Jinghe pointed out that the revision of the "Regulations" fully implemented the "four strictest" requirements.
According to Xu Jinghe, deputy director of the State Drug Administration, the biggest features of the Regulations can be summarized in four words: one is "new", adding many new systems, new mechanisms, and new methods to improve governance; the second is "excellent".
", simplified and optimized the review, review and approval procedures, and focused on improving the effectiveness of supervision; the third is "full", which refines and improves the responsibility for the entire life cycle of medical device quality and safety; the fourth is "strict", and further increases punishment for violations of laws and regulations Intensity.
", simplified and optimized the review, review and approval procedures, and focused on improving the effectiveness of supervision; the third is "full", which refines and improves the responsibility for the entire life cycle of medical device quality and safety; the fourth is "strict", and further increases punishment for violations of laws and regulations Intensity.
▍Key 1: Pilot medical device registrant system, covering 22 provincial-level regions
Beginning in 2018, the State Food and Drug Administration launched a pilot program for the medical device registrant system, and the scope of the pilot program has reached 22 provinces, autonomous regions, and municipalities directly under the Central Government.
As of yesterday, a total of 1,054 products nationwide have been approved for listing in accordance with the pilot medical device registrant system.
As of yesterday, a total of 1,054 products nationwide have been approved for listing in accordance with the pilot medical device registrant system.
▍Key 2: Announcement of the number of national medical device manufacturers and operating companies
State Food and Drug Administration released data show that, at present, there are medical equipment manufacturing enterprises more than 25,000, more than 897,000 enterprises.
In 2019, the main operating income of national medical devices reached more than 720 billion yuan, accounting for about 20% of the global medical device market.
In 2019, the main operating income of national medical devices reached more than 720 billion yuan, accounting for about 20% of the global medical device market.
The number of national medical device registration certificates reached 139,000, the number of registered medical devices reached 115,000, and the number of innovative medical devices approved for marketing reached 103.
There are now 1,791 medical device standards, including 227 national standards and 1,564 industry standards.
The consistency of international standards has reached 90.
4%.
There are now 1,791 medical device standards, including 227 national standards and 1,564 industry standards.
The consistency of international standards has reached 90.
4%.
▍Key 3: Prioritize review and approval of innovative medical devices
According to Wang Zhenjiang, director of the Legislative Third Bureau of the Ministry of Justice, three aspects have been focused on during the revision of the Regulations: First, encourage innovation and promote high-quality industrial development.
The "Regulations" clearly put medical device innovation into the development focus, prioritize review and approval of innovative medical devices, support the promotion and use of innovative medical devices, and promote the high-quality development of the industry.
Improve the medical device innovation system, and provide support in scientific and technological projects, financing, credit, pharmnet.
com.
cn/news/yyzb/" target="_blank">bidding and procurement, and medical insurance.
At the same time, it emphasizes strengthening the protection of intellectual property rights and improving the ability of independent innovation.
The "Regulations" clearly put medical device innovation into the development focus, prioritize review and approval of innovative medical devices, support the promotion and use of innovative medical devices, and promote the high-quality development of the industry.
Improve the medical device innovation system, and provide support in scientific and technological projects, financing, credit, pharmnet.
com.
cn/news/yyzb/" target="_blank">bidding and procurement, and medical insurance.
At the same time, it emphasizes strengthening the protection of intellectual property rights and improving the ability of independent innovation.
▍Key 4: Step by step implementation of the unique identification system for medical devices, giving "electronic ID cards"
Scientific supervision, promote the modernization of the supervision system and supervision capabilities.
The "Regulations" further enriched the supervision methods and stipulated extended inspection measures.
When necessary, relevant units that provide products or services for the development, production, operation, and use of medical devices can be inspected, which further reflects the full supervision of medical devices.
It stipulates the step-by-step implementation of a unique identification system for medical devices, assigning "electronic ID cards" to medical devices, and strengthening the management of the entire life cycle from source production to clinical application.
The "Regulations" further enriched the supervision methods and stipulated extended inspection measures.
When necessary, relevant units that provide products or services for the development, production, operation, and use of medical devices can be inspected, which further reflects the full supervision of medical devices.
It stipulates the step-by-step implementation of a unique identification system for medical devices, assigning "electronic ID cards" to medical devices, and strengthening the management of the entire life cycle from source production to clinical application.
▍Key 5: Quality problems, a fine of up to 30 times the value of the goods can be imposed
Increase the cost of violations and severely punish violations.
The "Regulations" set different levels of penalties according to the degree of social harm of illegal acts.
For illegal acts involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
Increase the "punishment to the person" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to life of the relevant responsible personnel of units that seriously violate the law.
The "Regulations" set different levels of penalties according to the degree of social harm of illegal acts.
For illegal acts involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
Increase the "punishment to the person" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to life of the relevant responsible personnel of units that seriously violate the law.
▍Key 6: Simplify and optimize the clinical evaluation system for medical devices
The new "Regulations" made the following provisions on the clinical evaluation system: First, for non-clinical evaluations that can prove safe and effective, they are exempt from clinical evaluations.
The second is to carry out clinical evaluation can take the following paths, including carrying out clinical trials, through the analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices.
The third is that when the clinical evaluation of medical devices is carried out further, the clinical literature and clinical data are not enough to confirm the product safety and effective medical devices, and clinical trials should be carried out.
The fourth is to optimize the clinical trial review procedures, and the implementation of clinical trials has been changed from "express permission" to "implicit permission" in the past.
The second is to carry out clinical evaluation can take the following paths, including carrying out clinical trials, through the analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices.
The third is that when the clinical evaluation of medical devices is carried out further, the clinical literature and clinical data are not enough to confirm the product safety and effective medical devices, and clinical trials should be carried out.
The fourth is to optimize the clinical trial review procedures, and the implementation of clinical trials has been changed from "express permission" to "implicit permission" in the past.
In the current practice of medical device review and approval, only about 12.
5% of the entire review is required for clinical trials; about 42.
5% for other clinical evaluations; and about 42.
5% of those that are exempted from clinical evaluations Accounted for 45%.
The reform of this classified management system is conducive to further saving resources, improving efficiency, encouraging innovation, and better meeting the public's need for machinery.
5% of the entire review is required for clinical trials; about 42.
5% for other clinical evaluations; and about 42.
5% of those that are exempted from clinical evaluations Accounted for 45%.
The reform of this classified management system is conducive to further saving resources, improving efficiency, encouraging innovation, and better meeting the public's need for machinery.
Medical News, April 1st, Medical News, April 1st
All cities involved
On March 30, the National Medical Products Administration and the National Standardization Administration issued the "Opinions on Further Promoting the High-Quality Development of Medical Device Standardization".
The document requires the market supervision bureaus (departments and commissions of the Xinjiang Production and Construction Corps) of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps.
), Food and Drug Administration, national professional standardization technical committees and sub-technical committees in various medical device fields, various medical device standardization technical centralized units, and all relevant units to implement.
The document requires the market supervision bureaus (departments and commissions of the Xinjiang Production and Construction Corps) of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps.
), Food and Drug Administration, national professional standardization technical committees and sub-technical committees in various medical device fields, various medical device standardization technical centralized units, and all relevant units to implement.
The key points of Cyber Blue Equipment are as follows:
▍Key 1: By 2025, my country will basically establish a full life cycle system for medical devices
The document points out that by 2025, it will be basically completed to meet the needs of my country's medical device development, production, operation, use, supervision and management and other life-cycle management needs, meet the new requirements of strict safety bottom line and boost quality, and be in line with international standards and have Chinese characteristics.
, Scientific and advanced medical device standard system, realize the comprehensive improvement of standard quality, higher quality, timely and diversified standard supply, more complete, efficient and coordinated standard management, and deeper and more effective standard international exchanges and cooperation.
, Scientific and advanced medical device standard system, realize the comprehensive improvement of standard quality, higher quality, timely and diversified standard supply, more complete, efficient and coordinated standard management, and deeper and more effective standard international exchanges and cooperation.
▍Key 2: Comprehensive evaluation of mandatory medical device standards
Research and formulate general principles and basic requirements for the construction of the standard system, rationally plan the layout of the standard system, and scientifically formulate standard plans around the major deployment of medical device supervision and industrial development.
Implement the statistical analysis and reporting system for the implementation of mandatory national standards, comprehensively carry out mandatory standard assessments, continue to optimize the mandatory standards for medical devices, strictly limit the scope of mandatory standard formulation, and gradually transform mandatory industry standards with a wide range of applications and great influence It is a mandatory national standard.
Implement the statistical analysis and reporting system for the implementation of mandatory national standards, comprehensively carry out mandatory standard assessments, continue to optimize the mandatory standards for medical devices, strictly limit the scope of mandatory standard formulation, and gradually transform mandatory industry standards with a wide range of applications and great influence It is a mandatory national standard.
▍Key 3: Encourage the development and revision of recommended industry standards in emerging technology fields and urgently needed by supervision
Optimizing recommended standards, focusing on supporting the formulation and revision of recommended national standards that are basic and common, supporting compulsory national standards, and leading the industry; encourage the formulation and revision of recommended industry standards in emerging technology fields and urgently needed by supervision.
Cultivate the development of group standards and encourage social groups to actively develop group standards in the field of medical devices around new technologies and new business formats.
Establish a medical device standard system with reasonable structure, clear levels, coordinated and supporting facilities, keeping the bottom line to ensure safety, and chasing the top line to promote development.
Cultivate the development of group standards and encourage social groups to actively develop group standards in the field of medical devices around new technologies and new business formats.
Establish a medical device standard system with reasonable structure, clear levels, coordinated and supporting facilities, keeping the bottom line to ensure safety, and chasing the top line to promote development.
Improve medical device terminology definitions, marking and identification, risk management, quality management, clinical evaluation management, usability engineering, statistical technology, digital security and other basic standards covering the entire life cycle of medical devices.
Speed up the formulation and revision of general standards for basic safety and basic performance, biological evaluation of medical electrical equipment.
Speed up the formulation and revision of general standards for basic safety and basic performance, biological evaluation of medical electrical equipment.
▍Key 4: Active medical devices will focus on
Strengthen the development of active medical device standards.
Accelerate the advancement of common technology research and standard formulation of medical equipment in emerging fields such as medical robots, artificial intelligence, active implants, medical software, 5G+ industrial Internet, and multi-technology integration.
Explore and promote the formulation of standards for key core components of medical devices.
Accelerate the advancement of common technology research and standard formulation of medical equipment in emerging fields such as medical robots, artificial intelligence, active implants, medical software, 5G+ industrial Internet, and multi-technology integration.
Explore and promote the formulation of standards for key core components of medical devices.
Improve medical respiratory and anesthesia equipment, disinfection and sterilization equipment, oral digital equipment, medical body circulation equipment, radiotherapy and nuclear medicine equipment, medical ultrasound equipment, physical therapy equipment, medical laboratory equipment, medical X-ray diagnostic equipment, and medical laser equipment , Medical radio frequency equipment and other high-end medical equipment related standards.
▍Key 5: Strengthen the development of passive medical device standards
Strengthen the development of standards for passive medical devices.
Strengthen the research of new biomedical material standards, and promote the formulation and revision of new technologies, new processes, and new materials standards for drug-device combination products, additive manufacturing, biodegradable products, tissue engineering products, recombinant collagen products, and nanometer products.
Carry out research on hazardous substance characterization and toxicological evaluation methods and standard formulation.
Strengthen the research of new biomedical material standards, and promote the formulation and revision of new technologies, new processes, and new materials standards for drug-device combination products, additive manufacturing, biodegradable products, tissue engineering products, recombinant collagen products, and nanometer products.
Carry out research on hazardous substance characterization and toxicological evaluation methods and standard formulation.
Establish a standard system for preclinical animal testing.
Intensify the standardization of new products such as passive implants, medical dressings, biological protective equipment, dental equipment, and optics.
Intensify the standardization of new products such as passive implants, medical dressings, biological protective equipment, dental equipment, and optics.
▍Key 6: Strengthen the development of in vitro diagnostic reagent standards
Accelerate the development of standards for diagnostic reagents and related methods for high-risk infectious diseases, and carry out research on in vitro diagnostic reagent standards related to the prevention and control of the new crown pneumonia epidemic.
Promote the formulation and revision of standards in the fields of high-throughput sequencing and other new molecular diagnostic technologies, clinical mass spectrometry technologies, companion diagnostic reagents, point-of-care testing, traceability and reference measurement systems.
Promote the formulation and revision of standards in the fields of high-throughput sequencing and other new molecular diagnostic technologies, clinical mass spectrometry technologies, companion diagnostic reagents, point-of-care testing, traceability and reference measurement systems.
The new "Regulations" will be formally implemented soon
A few days ago, the State Council Information Office held a regular policy briefing to introduce the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations").
Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Drug Administration, attended the briefing and answered questions from reporters.
Xu Jinghe pointed out that the revision of the "Regulations" fully implemented the "four strictest" requirements.
Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Drug Administration, attended the briefing and answered questions from reporters.
Xu Jinghe pointed out that the revision of the "Regulations" fully implemented the "four strictest" requirements.
According to Xu Jinghe, deputy director of the State Drug Administration, the biggest features of the Regulations can be summarized in four words: one is "new", adding many new systems, new mechanisms, and new methods to improve governance; the second is "excellent".
", simplified and optimized the review, review and approval procedures, and focused on improving the effectiveness of supervision; the third is "full", which refines and improves the responsibility for the entire life cycle of medical device quality and safety; the fourth is "strict", and further increases punishment for violations of laws and regulations Intensity.
", simplified and optimized the review, review and approval procedures, and focused on improving the effectiveness of supervision; the third is "full", which refines and improves the responsibility for the entire life cycle of medical device quality and safety; the fourth is "strict", and further increases punishment for violations of laws and regulations Intensity.
▍Key 1: Pilot medical device registrant system, covering 22 provincial-level regions
Beginning in 2018, the State Food and Drug Administration launched a pilot program for the medical device registrant system, and the scope of the pilot program has reached 22 provinces, autonomous regions, and municipalities directly under the Central Government.
As of yesterday, a total of 1,054 products nationwide have been approved for listing in accordance with the pilot medical device registrant system.
As of yesterday, a total of 1,054 products nationwide have been approved for listing in accordance with the pilot medical device registrant system.
▍Key 2: Announcement of the number of national medical device manufacturers and operating companies
State Food and Drug Administration released data show that, at present, there are medical equipment manufacturing enterprises more than 25,000, more than 897,000 enterprises.
In 2019, the main operating income of national medical devices reached more than 720 billion yuan, accounting for about 20% of the global medical device market.
In 2019, the main operating income of national medical devices reached more than 720 billion yuan, accounting for about 20% of the global medical device market.
The number of national medical device registration certificates reached 139,000, the number of registered medical devices reached 115,000, and the number of innovative medical devices approved for marketing reached 103.
There are now 1,791 medical device standards, including 227 national standards and 1,564 industry standards.
The consistency of international standards has reached 90.
4%.
There are now 1,791 medical device standards, including 227 national standards and 1,564 industry standards.
The consistency of international standards has reached 90.
4%.
▍Key 3: Prioritize review and approval of innovative medical devices
According to Wang Zhenjiang, director of the Legislative Third Bureau of the Ministry of Justice, three aspects have been focused on during the revision of the Regulations: First, encourage innovation and promote high-quality industrial development.
The "Regulations" clearly put medical device innovation into the development focus, prioritize review and approval of innovative medical devices, support the promotion and use of innovative medical devices, and promote the high-quality development of the industry.
Improve the medical device innovation system, and provide support in scientific and technological projects, financing, credit, pharmnet.
com.
cn/news/yyzb/" target="_blank">bidding and procurement, and medical insurance.
At the same time, it emphasizes strengthening the protection of intellectual property rights and improving the ability of independent innovation.
The "Regulations" clearly put medical device innovation into the development focus, prioritize review and approval of innovative medical devices, support the promotion and use of innovative medical devices, and promote the high-quality development of the industry.
Improve the medical device innovation system, and provide support in scientific and technological projects, financing, credit, pharmnet.
com.
cn/news/yyzb/" target="_blank">bidding and procurement, and medical insurance.
At the same time, it emphasizes strengthening the protection of intellectual property rights and improving the ability of independent innovation.
▍Key 4: Step by step implementation of the unique identification system for medical devices, giving "electronic ID cards"
Scientific supervision, promote the modernization of the supervision system and supervision capabilities.
The "Regulations" further enriched the supervision methods and stipulated extended inspection measures.
When necessary, relevant units that provide products or services for the development, production, operation, and use of medical devices can be inspected, which further reflects the full supervision of medical devices.
It stipulates the step-by-step implementation of a unique identification system for medical devices, assigning "electronic ID cards" to medical devices, and strengthening the management of the entire life cycle from source production to clinical application.
The "Regulations" further enriched the supervision methods and stipulated extended inspection measures.
When necessary, relevant units that provide products or services for the development, production, operation, and use of medical devices can be inspected, which further reflects the full supervision of medical devices.
It stipulates the step-by-step implementation of a unique identification system for medical devices, assigning "electronic ID cards" to medical devices, and strengthening the management of the entire life cycle from source production to clinical application.
▍Key 5: Quality problems, a fine of up to 30 times the value of the goods can be imposed
Increase the cost of violations and severely punish violations.
The "Regulations" set different levels of penalties according to the degree of social harm of illegal acts.
For illegal acts involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
Increase the "punishment to the person" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to life of the relevant responsible personnel of units that seriously violate the law.
The "Regulations" set different levels of penalties according to the degree of social harm of illegal acts.
For illegal acts involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
Increase the "punishment to the person" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to life of the relevant responsible personnel of units that seriously violate the law.
▍Key 6: Simplify and optimize the clinical evaluation system for medical devices
The new "Regulations" made the following provisions on the clinical evaluation system: First, for non-clinical evaluations that can prove safe and effective, they are exempt from clinical evaluations.
The second is to carry out clinical evaluation can take the following paths, including carrying out clinical trials, through the analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices.
The third is that when the clinical evaluation of medical devices is carried out further, the clinical literature and clinical data are not enough to confirm the product safety and effective medical devices, and clinical trials should be carried out.
The fourth is to optimize the clinical trial review procedures, and the implementation of clinical trials has been changed from "express permission" to "implicit permission" in the past.
The second is to carry out clinical evaluation can take the following paths, including carrying out clinical trials, through the analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices.
The third is that when the clinical evaluation of medical devices is carried out further, the clinical literature and clinical data are not enough to confirm the product safety and effective medical devices, and clinical trials should be carried out.
The fourth is to optimize the clinical trial review procedures, and the implementation of clinical trials has been changed from "express permission" to "implicit permission" in the past.
In the current practice of medical device review and approval, only about 12.
5% of the entire review is required for clinical trials; about 42.
5% for other clinical evaluations; and about 42.
5% of those that are exempted from clinical evaluations Accounted for 45%.
The reform of this classified management system is conducive to further saving resources, improving efficiency, encouraging innovation, and better meeting the public's need for machinery.
5% of the entire review is required for clinical trials; about 42.
5% for other clinical evaluations; and about 42.
5% of those that are exempted from clinical evaluations Accounted for 45%.
The reform of this classified management system is conducive to further saving resources, improving efficiency, encouraging innovation, and better meeting the public's need for machinery.
Medical News, April 1st, Medical News, April 1st
All cities involved
All cities involved
All cities involved
All cities involved On March 30, the National Medical Products Administration and the National Standardization Administration issued the "Opinions on Further Promoting the High-Quality Development of Medical Device Standardization".
The document requires the market supervision bureaus (departments and commissions of the Xinjiang Production and Construction Corps) of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps.
), Food and Drug Administration, national professional standardization technical committees and sub-technical committees in various medical device fields, various medical device standardization technical centralized units, and all relevant units to implement.
Medicines Medicines Medicines Medical Devices Medical Devices Medical DevicesThe document requires the market supervision bureaus (departments and commissions of the Xinjiang Production and Construction Corps) of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps.
), Food and Drug Administration, national professional standardization technical committees and sub-technical committees in various medical device fields, various medical device standardization technical centralized units, and all relevant units to implement.
The key points of Cyber Blue Equipment are as follows:
▍Key 1: By 2025, my country will basically establish a full life cycle system for medical devices
The document points out that by 2025, it will be basically completed to meet the needs of my country's medical device development, production, operation, use, supervision and management and other life-cycle management needs, meet the new requirements of strict safety bottom line and boost quality, and be in line with international standards and have Chinese characteristics.
, Scientific and advanced medical device standard system, realize the comprehensive improvement of standard quality, higher quality, timely and diversified standard supply, more complete, efficient and coordinated standard management, and deeper and more effective standard international exchanges and cooperation.
, Scientific and advanced medical device standard system, realize the comprehensive improvement of standard quality, higher quality, timely and diversified standard supply, more complete, efficient and coordinated standard management, and deeper and more effective standard international exchanges and cooperation.
▍Key 2: Comprehensive evaluation of mandatory medical device standards
Research and formulate general principles and basic requirements for the construction of the standard system, rationally plan the layout of the standard system, and scientifically formulate standard plans around the major deployment of medical device supervision and industrial development.
Implement the statistical analysis and reporting system for the implementation of mandatory national standards, comprehensively carry out mandatory standard assessments, continue to optimize the mandatory standards for medical devices, strictly limit the scope of mandatory standard formulation, and gradually transform mandatory industry standards with a wide range of applications and great influence It is a mandatory national standard.
Implement the statistical analysis and reporting system for the implementation of mandatory national standards, comprehensively carry out mandatory standard assessments, continue to optimize the mandatory standards for medical devices, strictly limit the scope of mandatory standard formulation, and gradually transform mandatory industry standards with a wide range of applications and great influence It is a mandatory national standard.
▍Key 3: Encourage the development and revision of recommended industry standards in emerging technology fields and urgently needed by supervision
Optimizing recommended standards, focusing on supporting the formulation and revision of recommended national standards that are basic and common, supporting compulsory national standards, and leading the industry; encourage the formulation and revision of recommended industry standards in emerging technology fields and urgently needed by supervision.
Cultivate the development of group standards and encourage social groups to actively develop group standards in the field of medical devices around new technologies and new business formats.
Establish a medical device standard system with reasonable structure, clear levels, coordinated and supporting facilities, keeping the bottom line to ensure safety, and chasing the top line to promote development.
Cultivate the development of group standards and encourage social groups to actively develop group standards in the field of medical devices around new technologies and new business formats.
Establish a medical device standard system with reasonable structure, clear levels, coordinated and supporting facilities, keeping the bottom line to ensure safety, and chasing the top line to promote development.
Improve medical device terminology definitions, marking and identification, risk management, quality management, clinical evaluation management, usability engineering, statistical technology, digital security and other basic standards covering the entire life cycle of medical devices.
Speed up the formulation and revision of general standards for basic safety and basic performance, biological evaluation of medical electrical equipment.
Speed up the formulation and revision of general standards for basic safety and basic performance, biological evaluation of medical electrical equipment.
▍Key 4: Active medical devices will focus on
Strengthen the development of active medical device standards.
Accelerate the advancement of common technology research and standard formulation of medical equipment in emerging fields such as medical robots, artificial intelligence, active implants, medical software, 5G+ industrial Internet, and multi-technology integration.
Explore and promote the formulation of standards for key core components of medical devices.
Accelerate the advancement of common technology research and standard formulation of medical equipment in emerging fields such as medical robots, artificial intelligence, active implants, medical software, 5G+ industrial Internet, and multi-technology integration.
Explore and promote the formulation of standards for key core components of medical devices.
Improve medical respiratory and anesthesia equipment, disinfection and sterilization equipment, oral digital equipment, medical body circulation equipment, radiotherapy and nuclear medicine equipment, medical ultrasound equipment, physical therapy equipment, medical laboratory equipment, medical X-ray diagnostic equipment, and medical laser equipment , Medical radio frequency equipment and other high-end medical equipment related standards.
Disinfection disinfection disinfection ▍Key 5: Strengthen the development of passive medical device standards
Strengthen the development of standards for passive medical devices.
Strengthen the research of new biomedical material standards, and promote the formulation and revision of new technologies, new processes, and new materials standards for drug-device combination products, additive manufacturing, biodegradable products, tissue engineering products, recombinant collagen products, and nanometer products.
Carry out research on hazardous substance characterization and toxicological evaluation methods and standard formulation.
Strengthen the research of new biomedical material standards, and promote the formulation and revision of new technologies, new processes, and new materials standards for drug-device combination products, additive manufacturing, biodegradable products, tissue engineering products, recombinant collagen products, and nanometer products.
Carry out research on hazardous substance characterization and toxicological evaluation methods and standard formulation.
Establish a standard system for preclinical animal testing.
Intensify the standardization of new products such as passive implants, medical dressings, biological protective equipment, dental equipment, and optics.
Intensify the standardization of new products such as passive implants, medical dressings, biological protective equipment, dental equipment, and optics.
▍Key 6: Strengthen the development of in vitro diagnostic reagent standards
Accelerate the development of standards for diagnostic reagents and related methods for high-risk infectious diseases, and carry out research on in vitro diagnostic reagent standards related to the prevention and control of the new crown pneumonia epidemic.
Promote the formulation and revision of standards in the fields of high-throughput sequencing and other new molecular diagnostic technologies, clinical mass spectrometry technologies, companion diagnostic reagents, point-of-care testing, traceability and reference measurement systems.
Promote the formulation and revision of standards in the fields of high-throughput sequencing and other new molecular diagnostic technologies, clinical mass spectrometry technologies, companion diagnostic reagents, point-of-care testing, traceability and reference measurement systems.
The new "Regulations" will be formally implemented soon
The new "Regulations" will be formally implemented soon A few days ago, the State Council Information Office held a regular policy briefing to introduce the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations").
Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Drug Administration, attended the briefing and answered questions from reporters.
Xu Jinghe pointed out that the revision of the "Regulations" fully implemented the "four strictest" requirements.
Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Drug Administration, attended the briefing and answered questions from reporters.
Xu Jinghe pointed out that the revision of the "Regulations" fully implemented the "four strictest" requirements.
According to Xu Jinghe, deputy director of the State Drug Administration, the biggest features of the Regulations can be summarized in four words: one is "new", adding many new systems, new mechanisms, and new methods to improve governance; the second is "excellent".
", simplified and optimized the review, review and approval procedures, and focused on improving the effectiveness of supervision; the third is "full", which refines and improves the responsibility for the entire life cycle of medical device quality and safety; the fourth is "strict", and further increases punishment for violations of laws and regulations Intensity.
", simplified and optimized the review, review and approval procedures, and focused on improving the effectiveness of supervision; the third is "full", which refines and improves the responsibility for the entire life cycle of medical device quality and safety; the fourth is "strict", and further increases punishment for violations of laws and regulations Intensity.
▍Key 1: Pilot medical device registrant system, covering 22 provincial-level regions
Beginning in 2018, the State Food and Drug Administration launched a pilot program for the medical device registrant system, and the scope of the pilot program has reached 22 provinces, autonomous regions, and municipalities directly under the Central Government.
As of yesterday, a total of 1,054 products nationwide have been approved for listing in accordance with the pilot medical device registrant system.
As of yesterday, a total of 1,054 products nationwide have been approved for listing in accordance with the pilot medical device registrant system.
▍Key 2: Announcement of the number of national medical device manufacturers and operating companies
State Food and Drug Administration released data show that, at present, there are medical equipment manufacturing enterprises more than 25,000, more than 897,000 enterprises.
In 2019, the main operating income of national medical devices reached more than 720 billion yuan, accounting for about 20% of the global medical device market.
Enterprise business enterpriseIn 2019, the main operating income of national medical devices reached more than 720 billion yuan, accounting for about 20% of the global medical device market.
The number of national medical device registration certificates reached 139,000, the number of registered medical devices reached 115,000, and the number of innovative medical devices approved for marketing reached 103.
There are now 1,791 medical device standards, including 227 national standards and 1,564 industry standards.
The consistency of international standards has reached 90.
4%.
There are now 1,791 medical device standards, including 227 national standards and 1,564 industry standards.
The consistency of international standards has reached 90.
4%.
▍Key 3: Prioritize review and approval of innovative medical devices
According to Wang Zhenjiang, director of the Legislative Third Bureau of the Ministry of Justice, three aspects have been focused on during the revision of the Regulations: First, encourage innovation and promote high-quality industrial development.
The "Regulations" clearly put medical device innovation into the development focus, prioritize review and approval of innovative medical devices, support the promotion and use of innovative medical devices, and promote the high-quality development of the industry.
Improve the medical device innovation system, and provide support in scientific and technological projects, financing, credit, pharmnet.
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cn/news/yyzb/" target="_blank">bidding and procurement, and medical insurance.
At the same time, it emphasizes strengthening the protection of intellectual property rights and improving the ability of independent innovation.
pharmnet. The "Regulations" clearly put medical device innovation into the development focus, prioritize review and approval of innovative medical devices, support the promotion and use of innovative medical devices, and promote the high-quality development of the industry.
Improve the medical device innovation system, and provide support in scientific and technological projects, financing, credit, pharmnet.
com.
cn/news/yyzb/" target="_blank">bidding and procurement, and medical insurance.
At the same time, it emphasizes strengthening the protection of intellectual property rights and improving the ability of independent innovation.
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cn/news/yyzb/" target="_blank"> Tender Tender
▍Key 4: Step by step implementation of the unique identification system for medical devices, giving "electronic ID cards"
Scientific supervision, promote the modernization of the supervision system and supervision capabilities.
The "Regulations" further enriched the supervision methods and stipulated extended inspection measures.
When necessary, relevant units that provide products or services for the development, production, operation, and use of medical devices can be inspected, which further reflects the full supervision of medical devices.
It stipulates the step-by-step implementation of a unique identification system for medical devices, assigning "electronic ID cards" to medical devices, and strengthening the management of the entire life cycle from source production to clinical application.
The "Regulations" further enriched the supervision methods and stipulated extended inspection measures.
When necessary, relevant units that provide products or services for the development, production, operation, and use of medical devices can be inspected, which further reflects the full supervision of medical devices.
It stipulates the step-by-step implementation of a unique identification system for medical devices, assigning "electronic ID cards" to medical devices, and strengthening the management of the entire life cycle from source production to clinical application.
▍Key 5: Quality problems, a fine of up to 30 times the value of the goods can be imposed
Increase the cost of violations and severely punish violations.
The "Regulations" set different levels of penalties according to the degree of social harm of illegal acts.
For illegal acts involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
Increase the "punishment to the person" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to life of the relevant responsible personnel of units that seriously violate the law.
The "Regulations" set different levels of penalties according to the degree of social harm of illegal acts.
For illegal acts involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
Increase the "punishment to the person" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to life of the relevant responsible personnel of units that seriously violate the law.
▍Key 6: Simplify and optimize the clinical evaluation system for medical devices
The new "Regulations" made the following provisions on the clinical evaluation system: First, for non-clinical evaluations that can prove safe and effective, they are exempt from clinical evaluations.
The second is to carry out clinical evaluation can take the following paths, including carrying out clinical trials, through the analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices.
The third is that when the clinical evaluation of medical devices is carried out further, the clinical literature and clinical data are not enough to confirm the product safety and effective medical devices, and clinical trials should be carried out.
The fourth is to optimize the clinical trial review procedures, and the implementation of clinical trials has been changed from "express permission" to "implicit permission" in the past.
The second is to carry out clinical evaluation can take the following paths, including carrying out clinical trials, through the analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices.
The third is that when the clinical evaluation of medical devices is carried out further, the clinical literature and clinical data are not enough to confirm the product safety and effective medical devices, and clinical trials should be carried out.
The fourth is to optimize the clinical trial review procedures, and the implementation of clinical trials has been changed from "express permission" to "implicit permission" in the past.
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