Nearly half of the products are exempt from clinical evaluation!

Medical Network, March 29, March 26, the "Regular Policy Briefing of the State Council" explained the relevant situation of the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") that will be formally implemented on June 1 .

 

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.

 

In addition, in response to the issue of the medical device registrant system, which is of high concern in the industry, the reporter learned at the meeting that starting in 2018, the State Food and Drug Administration launched a pilot program for the medical device registrant system, and the scope of the trial reached 22 provinces and autonomous regions.
, 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.

 

Device Registration Certificate 13.
9 Wan Jian

 

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.

 

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%.

 

　　Xu Jinghe pointed out that over the past 40 years of reform and opening up, my country's medical device industry has developed rapidly, and a relatively complete medical device production and supply system has been established, which has achieved a historic leap.
Today, my country's medical device industry has entered the "golden period" of vigorous development.
A number of local medical device manufacturers with core technologies have rapidly emerged, a number of multinational medical device giants have taken root in my country, and the availability of medical device products has continued to increase.
.

 

　　Interpretation of the three key revisions

 

　　In October 2017, the Central Office and the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices", which put forward specific requirements for deepening the reform of the review and approval system for 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.

 

　　Second, scientific supervision and modernization of the supervision system and supervision capabilities should be promoted.
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.

 

　　Third, 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.

 

　　Simplify and optimize device review and approval

 

　　The reporter also learned that the clinical evaluation system is a very important system in the medical device review and approval system.
This time the "Regulations" have many new highlights in clinical evaluation and clinical trial management.

 

　　According to Changjiang Deyuan, Department of Device Registration, National Food and Drug Administration, clinical evaluation is to confirm whether the product meets the requirements for use or intended use, as well as its safety and effectiveness, by seeking corresponding clinical evidence.
In addition to verifying through clinical trials, clinical evaluation can also prove the safety and effectiveness of medical devices by analyzing and evaluating the clinical literature and clinical data of the same type of medical devices.

 

　　In order to continuously simplify and optimize the clinical evaluation system of medical devices, the new "Regulations" have made the following provisions on the clinical evaluation system: First, non-clinical evaluations can be proven safe and effective, and clinical evaluations are exempted.
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.

 

　　Text record

 

　　Xu Jinghe, Deputy Director of the State Drug Administration:

 

　　Good afternoon, everyone.
I am very happy to meet with you.
First of all, I would like to express my sincere thanks to you for your long-term support and help in drug supervision.

 

　　Medical equipment is related to the health and life safety of the people and the overall situation of the country's economic and social development.
The Party Central Committee and the State Council have always attached great importance to the quality and safety of medical devices and innovative development, and made a series of major decisions and deployments.
General Secretary Xi Jinping emphasized that "the most stringent standards, the most stringent supervision, the most severe penalties, and the most serious accountability" should be used to ensure public health.

 

　　Over the past 40 years of reform and opening up, my country's medical device industry has developed rapidly, and a relatively complete medical device production and supply system has been established, achieving a historic leap.
Today, my country's medical device industry has entered a "golden period" of vigorous development.
Here are a few figures to share with you: At present, there are more than 25,000 medical device manufacturers and more than 897,000 operating companies in the country.
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.
A number of local medical device manufacturers with core technologies have emerged rapidly, a number of multinational medical device giants have taken root in my country, and the availability of medical device products has continued to increase.

 

　　At present, there are 139,000 medical device registration certificates nationwide, 115,000 registered medical devices, and 103 innovative medical devices approved for marketing.
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 currently 14 regulations of the medical device supervision department and 345 medical device technical guidelines.
The number of clinical trial institutions registered nationwide reached 998.
We have established 4 medical device supervision scientific research bases in cooperation with universities and scientific research institutions, and identified 27 key medical device laboratories.
Through these years of long-term efforts, the medical device supervision and governance system has become increasingly perfect, and the supervision and governance capabilities have continued to improve.

 

　　Since the establishment of the State Drug Administration, it has adhered to the lofty mission of protecting and promoting public health, adhered to the development path of scientific, legal, modern, and internationalized, continuously deepened the reform of the review and approval system, and continued to strengthen the supervision of the entire life cycle of medical devices, and strictly Investigate and punish all types of violations of laws and regulations, and earnestly safeguard the safety of the broad masses of people in using weapons.

 

　　In the prevention and control of the new crown pneumonia epidemic, the drug regulatory department opened up emergency channels, quickly approved a batch of in-vitro diagnostic reagents and other urgently needed medical devices, and effectively strengthened the quality and safety of products such as in-vitro diagnostic reagents, medical masks, medical protective clothing, and ventilators.
Supervision has made important contributions to the victory of epidemic prevention and control.

 

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　　Third, increase the cost of violations and severely punish violations.
The "Regulations" increase the penalties for illegal activities involving medical devices in accordance with the requirements of the "four most stringent", further protect the health of the people, and create a level playing field for law-abiding enterprises.
At the same time, different levels of penalties are set according to the degree of social harm of illegal activities to ensure a balance of legal responsibilities and equal penalties.

 

　　One is to increase penalties for violations involving quality and safety, and fines up to 30 times the value of the goods can be imposed.
The second is to intensify the penalties for prohibiting entry into the industry and the market, and depending on the circumstances of the violation, penalties such as the revocation of licenses, prohibition of relevant activities for a certain period of time, and non-acceptance of relevant license applications will be imposed on offenders depending on the circumstances of the violation.
The third is to increase the "punishment to the individual" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to lifelong on the relevant responsible personnel of units that seriously violate the law.
"Severe" punishment is not just that.
If you are interested, you can read the provisions further.
Thank you all.

 

　　 "

 

　　The newly revised "Regulations on the Supervision and Administration of Medical Devices" summarizes supervision experience, further clarifies the relationship between clinical evaluation and clinical trials, and puts forward clear management requirements for clinical evaluation.
What changes are there in this regard? Thank you.

 

　　Changjiang Deyuan, Department of Device Registration, State Food and Drug Administration:

 

　　Thank you for your question.
The process of medical device registration is actually a process of reviewing the safety, effectiveness and quality controllability of the products to be marketed.
The so-called clinical evaluation refers to confirming whether the product meets the requirements for use or intended use, as well as its safety and effectiveness by seeking corresponding clinical evidence.
Clinical trial is a method of clinical evaluation, which refers to the process of confirming the safety and effectiveness of medical devices through systematic experimental research on subjects in the institutions of medical device clinical trials.
In addition to clinical trials, clinical evaluation can also prove the safety and effectiveness of medical devices by analyzing and evaluating the clinical literature and clinical data of the same types of medical devices.

 

　　In recent years, with the continuous deepening of the reform of the medical device review and approval system, with the continuous improvement of the corporate management level, and the significant progress in the level of technical review capabilities, the medical device clinical evaluation system has been simplified and optimized, and the new "Regulations" The following provisions are made for the clinical evaluation system:

 

　　One is that for non-clinical evaluations that can prove to be 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.
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.
Thank you.

 

　　 "

 

　　We have noticed that the newly revised "Regulations" focus on the approval system for medical devices in public health emergencies.
Could you please introduce the relevant system arrangements and the reasons for such arrangements? Thank you.

 

　　Jiang Deyuan:

 

　　Thank you for your question.
The prevention and control of the new crown pneumonia epidemic is also a major test for the emergency approval of medical devices.
After the outbreak, the drug regulatory authorities earnestly implemented the decisions and deployments of the Party Central Committee and the State Council, performed their duties and fulfilled their duties, quickly activated the emergency approval mechanism for medical devices, and went all out to carry out emergency approval and post-marketing supervision of equipment for epidemic prevention and control.
Medical equipment has played a very important role in the overall battle against the epidemic.

 

　　We adhere to the principles of unified command, early intervention, follow-up review, and scientific approval, innovate working methods, communicate with science, technology, health and other departments in a timely manner, and incorporate major scientific research results into emergency approval in a timely manner.
We concentrate the high-quality resources and strength of the whole system, work day and night, carry out registration inspection, system verification, technical review in parallel, actively connect with enterprises, actively provide front-line services, strengthen the whole process of guidance, maximize the effect of review and approval, and speed up products Listed.

 

　　We adhere to departmental coordination, system linkage, multiple measures to build joint efforts, coordinate with market supervision, industry and information departments and other departments, implement "one enterprise, one policy" for conversion and expansion enterprises, and provide assistance and guidance.
A joint inspection team has been organized many times to go deep into the company's factory supervision and strengthen inspections.
Strengthen product sampling and risk monitoring, and urge enterprises to implement their main responsibilities to ensure product quality and safety.
At the same time, in accordance with the requirements of the joint prevention and control mechanism, cooperate with relevant departments to jointly ensure product supply and export guarantees.

 

　　In order to meet the needs of responding to major public health emergencies and expedite the use of emergency medical devices, the new "Regulations" system summarizes the experience of epidemic prevention and control, and adds and improves the following systems: First, the priority review and approval system, and innovation Medical devices are subject to priority review and approval.
The second is the conditional approval system.
Medical devices urgently needed in response to public health events may be approved with conditions on the basis of a comprehensive balance of benefits and risks.
The third is the emergency use system.
In the event of a particularly major public health emergency or other emergency that seriously threatens public health, medical devices can be used urgently within a certain range and time limit.

 

　　In addition, the new "Regulations" also added a special approval import system for clinical urgent needs.

 

　　In the next step, the State Drug Administration will further improve related systems in conjunction with the formulation and revision of supporting regulations and normative documents.
Recently, we have started the revision of the "Medical Device Registration Management Measures" and revised and improved the "Medical Device Emergency Approval Procedure".
Thank you.

 

　　 "

 

　　The newly revised "Regulations" fully implements the registrant system.
The Food and Drug Administration has already deployed some pilot projects.
How effective are these pilot projects? What is the significance of this system for strengthening the supervision of medical devices and implementing the main responsibility of enterprises? Thank you.

 

　　Xu Jinghe:

 

　　The medical device registrant system is a modern medical device management system commonly adopted by the international community, and it is also one of the core systems for the revision of the Regulations on the Supervision and Administration of Medical Devices.
The core of the system is that the medical device registrant is the "producer" of the medical device product, and is responsible for the safety and effectiveness of the medical device in the entire process of development, production, operation, and use.

 

　　In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" by the Office of the State Council of the Central Committee of the People’s Republic of China, the State Food and Drug Administration has launched a pilot program for the medical device registrant system since 2018.
Autonomous regions and municipalities directly under the Central Government.
The pilot work is mainly carried out around the following aspects: First, whether scientific research institutions can become medical device registrants.
The second is how to divide the rights and obligations between the registrant and the trustee when the registrant entrusts production.
The third is how to allocate the powers and responsibilities of the supervisory department when entrusting production in different places.
The fourth is how to effectively implement the registrant’s life cycle responsibilities.

 

　　During the pilot process, the provincial drug regulatory authorities have successively issued relevant documents such as application service guidelines, on-site inspection rules, and quality agreement model texts, standardizing and detailing relevant requirements.
The Yangtze River Delta and Beijing-Tianjin-Hebei region's medical device registrants related coordinated supervision measures were released, and the regional cooperation mechanism was explored.
As of yesterday, a total of 1,054 products nationwide have been approved for listing in accordance with the pilot medical device registrant system.
Practice has proved that the registrant system is conducive to encouraging R&D innovation, optimizing resource allocation, implementing main responsibility, and promoting management innovation.

 

　　The new "Regulations on the Supervision and Administration of Medical Devices" summarizes the experience of the pilot projects in the past few years, and further clarifies the core content of the medical device registrant system.

 

　　First, the basic positioning.
The “Regulations” clearly stipulate that medical device registrants and recorders shall strengthen the quality management of the entire life cycle of medical devices, and shall be responsible for the safety and effectiveness of medical devices in the entire process of development, production, operation, and use.

 

　　Second, in terms of production links.
The "Regulations" stipulate that medical device registrants and record holders can produce by themselves or entrust enterprises with corresponding conditions to produce them.
In the case of entrusted production, the registrant and recorder shall be responsible for the quality of the entrusted production of medical devices, strengthen the management of the entrusted production activities, and ensure that they are produced in accordance with statutory requirements.
It should be emphasized here that implantable medical devices with high risks must not be commissioned.

 

　　Third, in terms of business operations.
Medical device registrants and record holders shall supervise the operating enterprises to establish and improve the quality management system suitable for the medical devices they operate, and ensure their effective operation; those engaged in online sales shall comply with the relevant provisions of online sales.

 

　　Fourth, in terms of adverse event monitoring.
The "Regulations" stipulate that medical device registrants and recorders should establish a medical device adverse event monitoring system, and promptly investigate and deal with adverse events.
The new "Regulations" stipulate that medical device registrants and recorders should take the initiative to carry out re-evaluation of medical devices already on the market, and take corresponding risk control measures based on the results of the re-evaluation.

 

　　In the next step, the State Food and Drug Administration will further refine the registrant and filing system in the revised regulations to better release the multi-faceted dividends of this innovative system.
I also hope that friends in the media will pay more attention to such an important institutional innovation.
Thank you.

 

　　 "

 

　　The new "Regulations" reflect the requirements of the reform of decentralization, control and service.
In accordance with the requirement of'regulation to keep up', what new regulatory measures will be taken after the listing? Thank you.

 

　　Wang Zhexiong, Director of the Device Supervision Department of the State Drug Administration:

 

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　　The fifth is to implement the requirement that people be punished for violations.
Increasing the system of penalties for violations of the law is an innovation in legislation in the field of food and drug supervision in recent years.
There are more than 10 provisions in the new "Regulations" that stipulate that people should be punished for violations.
In addition to penalizing illegal units, the legal representatives, main responsible persons, directly responsible persons in charge and other responsible persons of the illegal units have stipulated property penalties, qualification penalties, and confiscation of the income received from the unit during the period of the illegal act, and A fine of up to three times the income received by the premises is forbidden to engage in the production and operation of medical devices for five years to life.
In addition, the new "Regulations" also added systems for the traceability of medical device unique identification, online sales management, and punishment for dishonesty, and revised and improved relevant regulations on the commissioned production of medical devices and the re-evaluation after the market.

 

　　In the next step, we will implement the new "Regulations", formulate and revise relevant departmental regulations, further implement detailed relevant systems and measures, strengthen supervision, improve efficiency, ensure the quality and safety of medical devices, and promote the high-quality development of the medical device industry.
Thank you.

 

　　 "

 

　　We all know that the supervision and governance of medical devices involves many aspects.
How do we grasp and handle the relationship between safety and development, risk and responsibility in the implementation of the "Regulations"?

 

　　Xu Jinghe:

 

　　Thank you reporter for your question.
Law is the institutional arrangement of public happiness.
Medical device supervision and management involves many relationships such as safety and development, risk and responsibility, system and capability, quality and efficiency.
Scientifically grasping and correctly handling these relationships is not only a kind of wisdom, but also an art.
Here is a brief talk about the relationship between several aspects:

 

　　First, we must scientifically grasp the relationship between security and development.
Security is the foundation of development, and development is the guarantee of security.
The new "Regulations" fully embodies the dialectical relationship between safety and development.
In terms of safety, the new "Regulations" adopt a series of systems and measures to strengthen the quality and safety of medical devices.
For example, medical device registrants and filing personnel are responsible for the quality and safety of the entire life cycle.
In terms of development, the new "Regulations" clearly propose that the country should improve the medical device innovation system, put medical device innovation into the focus of development, give priority to the review and approval of innovative medical devices, support the clinical promotion and application of innovative medical devices, and promote the high level of the medical device industry.
Quality development.

 

　　Second, we must scientifically grasp the relationship between risk and responsibility.
Risk management is the cornerstone of medical device management.
The new "Regulations" for the first time legislates risk management as the basic principle of medical device supervision.
On the basis of classified management, it further clarifies that clinical evaluation or clinical evaluation of medical devices can be carried out based on factors such as risks.
For the test, Director Deyuan has just introduced the relevant situation.
At the same time, registrants are required to improve the quality management system, formulate risk management and control plans and ensure effective implementation.
Responsibility governance is the essence of medical device governance.
Only when responsibilities are fully implemented can risks be fully prevented and controlled.
The new "Regulations" improve the three major responsibility systems.
In terms of the responsibility of business owners, a system of medical device registrants and recorders has been established; in terms of government supervision, the leadership and management responsibilities of local people's governments in medical devices have been clarified for the first time; In terms of social co-governance, the requirements of relevant departments and social organizations to support the innovative development of medical devices have been clarified.

 

　　Third, we must scientifically grasp the relationship between system and capability.
Modern medical device management is scientific management based on systems and capabilities.
Only a complete governance system can have excellent governance capabilities.
In terms of system construction, the new "Regulations" strengthened the construction of the medical device supervision system and strengthened the construction of the enterprise quality management system.
In terms of capacity building, the new "Regulations" emphasize that the country should improve the medical device innovation system and improve its independent innovation capabilities.
Local people's governments at or above the county level shall strengthen the capacity building of medical device supervision and management.
The registrant must have quality assurance capabilities.
Clinical trial institutions should strengthen the construction of clinical trial capabilities.

 

　　Fourth, we must scientifically grasp the relationship between quality and efficiency.
Quality and efficiency are the eternal theme of medical devices.
The new "Regulations" always adhere to the bottom line of medical device quality and safety, and ensure that this bottom line can be firmly grasped by fully implementing the "four most stringent" requirements.
At the same time, the new "Regulations" adopted a series of measures such as innovating the regulatory system, improving the regulatory system, optimizing the regulatory process, and enhancing the regulatory capabilities, such as implied licensing of clinical trials, shortening the review period of production and operation licenses, etc.
, to speed up medical care.
The speed of equipment products to market can better meet the public's demand for equipment.
It is also particularly emphasized here that while fully implementing the requirements of “decentralization, regulation and service” and accelerating the pace of product launches, it is necessary to ensure product quality and safety, that is, to organically unify quality and efficiency.

 

　　Fifth, we must scientifically grasp the relationship between unit responsibility and individual responsibility.
The content of legal relations is rights and obligations, and can also be summarized as responsibilities.
While the new "Regulations" comprehensively strengthen unit responsibilities, it also strengthens the penalties for natural persons for illegal acts, including property penalties, qualification penalties, and personal freedom penalties.
Both Director Zhenjiang and Director Zhexiong gave a good introduction just now.
It should be said that the perpetrators behind unit crimes or unit crimes are often natural persons.
While punishing units that violate the law, the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit should be increased in accordance with the law.
Legal sanctions, this "double-penalty system" is an important innovation in the construction of administrative rule of law, and it also captures the key points of penalties for illegal and criminal acts.
This system is conducive to further enhancing the deterrence of the law.
Therefore, everyone is very concerned about the "Medical Device Supervision and Administration Regulations" in implementing the "four most stringent" aspects, especially the many innovations in increasing penalties for illegal acts.
I believe this system will be able to effectively exert its deterrent effect.
Thank you.

　　Medical Network, March 29, March 26, the "Regular Policy Briefing of the State Council" explained the relevant situation of the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") that will be formally implemented on June 1 .

 

　　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.

 

　　In addition, in response to the issue of the medical device registrant system, which is of high concern in the industry, the reporter learned at the meeting that starting in 2018, the State Food and Drug Administration launched a pilot program for the medical device registrant system, and the scope of the trial reached 22 provinces and autonomous regions.
, 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.

 

　　Device Registration Certificate 13.
9 Wan Jian

 

　　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.

 

　　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%.

 

　　Xu Jinghe pointed out that over the past 40 years of reform and opening up, my country's medical device industry has developed rapidly, and a relatively complete medical device production and supply system has been established, which has achieved a historic leap.
Today, my country's medical device industry has entered the "golden period" of vigorous development.
A number of local medical device manufacturers with core technologies have rapidly emerged, a number of multinational medical device giants have taken root in my country, and the availability of medical device products has continued to increase.
.

 

　　Interpretation of the three key revisions

 

　　In October 2017, the Central Office and the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices", which put forward specific requirements for deepening the reform of the review and approval system for 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.

 

　　Second, scientific supervision and modernization of the supervision system and supervision capabilities should be promoted.
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.

 

　　Third, 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.

 

　　Simplify and optimize device review and approval

 

　　The reporter also learned that the clinical evaluation system is a very important system in the medical device review and approval system.
This time the "Regulations" have many new highlights in clinical evaluation and clinical trial management.

 

　　According to Changjiang Deyuan, Department of Device Registration, National Food and Drug Administration, clinical evaluation is to confirm whether the product meets the requirements for use or intended use, as well as its safety and effectiveness, by seeking corresponding clinical evidence.
In addition to verifying through clinical trials, clinical evaluation can also prove the safety and effectiveness of medical devices by analyzing and evaluating the clinical literature and clinical data of the same type of medical devices.

 

　　In order to continuously simplify and optimize the clinical evaluation system of medical devices, the new "Regulations" have made the following provisions on the clinical evaluation system: First, non-clinical evaluations can be proven safe and effective, and clinical evaluations are exempted.
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.

 

　　Text record

 

　　Xu Jinghe, Deputy Director of the State Drug Administration:

 

　　Good afternoon, everyone.
I am very happy to meet with you.
First of all, I would like to express my sincere thanks to you for your long-term support and help in drug supervision.

 

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　　Regarding some specific system measures, the "Regulations" implemented the reform requirements of “delegation, regulation, and service”, optimized registration procedures, improved registration efficiency, implemented an informative filing system, scientifically set clinical evaluation requirements, allowed the development of extended clinical trials, and encouraged medical treatment.
Institutions carry out clinical trials, strengthen the informatization of medical device supervision, further optimize the business environment, and release the vitality of innovation.
For example, informative filing is implemented for medical devices with relatively low risks.
That is to say, the filing is completed after the filing person submits the materials that meet the requirements.
There is no need to wait a few days for approval and the filing is completed when the materials are submitted.
It further reduces the burden of enterprise filing and improves work efficiency.
Of course, this kind of filing method puts forward higher requirements on enterprises to a certain extent, that is, the filing materials of enterprises must be true and legal in all aspects, and meet the requirements.
If there is a problem, they will also face some responsibilities.
The rights and obligations are equivalent.

 

　　Second, scientific supervision and modernization of the supervision system and supervision capabilities should be promoted.
In response to the problems and challenges in the supervision of medical devices under the new situation, the "Regulations" start with strengthening team building, innovating supervision methods, and promoting coordinated supervision, focusing on improving the medical device supervision system, and improving the scientific, effective and standardized supervision.
To promote the continuous improvement of the regulatory system and the modernization of regulatory capabilities.
In terms of team building, in view of the characteristics of a wide range of medical devices and involving many technical fields, the "Regulations" require the state to establish a professional and professional inspector system to strengthen the supervision and inspection of medical devices.

 

　　In terms of regulatory measures, in order to respond to emerging new situations and new business formats, the Regulations have further enriched regulatory measures, stipulated extended inspection measures, and provided products or services for the development, production, operation, and use of medical devices when necessary.
The inspection by relevant units 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.
On the basis of previous administrative licensing, administrative compulsion, and administrative punishment, diversified supervision methods such as warnings, responsibility interviews, and orders for rectification within a time limit have been stipulated to better adapt to the complex supervision situation.
In terms of coordinated supervision, the "Regulations" further clarified the division of responsibilities and information sharing and coordination mechanisms for drug supervision, health and health departments, and further strengthened the coordinated supervision of different departments and different levels to promote the formation of a joint supervision force.

 

　　Third, increase the cost of violations and severely punish violations.
The "Regulations" increase the penalties for illegal activities involving medical devices in accordance with the requirements of the "four most stringent", further protect the health of the people, and create a level playing field for law-abiding enterprises.
At the same time, different levels of penalties are set according to the degree of social harm of illegal activities to ensure a balance of legal responsibilities and equal penalties.

 

　　One is to increase penalties for violations involving quality and safety, and fines up to 30 times the value of the goods can be imposed.
The second is to intensify the penalties for prohibiting entry into the industry and the market, and depending on the circumstances of the violation, penalties such as the revocation of licenses, prohibition of relevant activities for a certain period of time, and non-acceptance of relevant license applications will be imposed on offenders depending on the circumstances of the violation.
The third is to increase the "punishment to the individual" measures, and impose penalties such as confiscation of income, fines, and prohibition of relevant activities for five years to lifelong on the relevant responsible personnel of units that seriously violate the law.
"Severe" punishment is not just that.
If you are interested, you can read the provisions further.
Thank you all.

 

　　 "

 

　　The newly revised "Regulations on the Supervision and Administration of Medical Devices" summarizes supervision experience, further clarifies the relationship between clinical evaluation and clinical trials, and puts forward clear management requirements for clinical evaluation.
What changes are there in this regard? Thank you.

 

　　Changjiang Deyuan, Department of Device Registration, State Food and Drug Administration:

 

　　Thank you for your question.
The process of medical device registration is actually a process of reviewing the safety, effectiveness and quality controllability of the products to be marketed.
The so-called clinical evaluation refers to confirming whether the product meets the requirements for use or intended use, as well as its safety and effectiveness by seeking corresponding clinical evidence.
Clinical trial is a method of clinical evaluation, which refers to the process of confirming the safety and effectiveness of medical devices through systematic experimental research on subjects in the institutions of medical device clinical trials.
In addition to clinical trials, clinical evaluation can also prove the safety and effectiveness of medical devices by analyzing and evaluating the clinical literature and clinical data of the same types of medical devices.

 

　　In recent years, with the continuous deepening of the reform of the medical device review and approval system, with the continuous improvement of the corporate management level, and the significant progress in the level of technical review capabilities, the medical device clinical evaluation system has been simplified and optimized, and the new "Regulations" The following provisions are made for the clinical evaluation system:

 

　　One is that for non-clinical evaluations that can prove to be 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.
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.
Thank you.

 

　　 "

 

　　We have noticed that the newly revised "Regulations" focus on the approval system for medical devices in public health emergencies.
Could you please introduce the relevant system arrangements and the reasons for such arrangements? Thank you.

 

　　Jiang Deyuan:

 

　　Thank you for your question.
The prevention and control of the new crown pneumonia epidemic is also a major test for the emergency approval of medical devices.
After the outbreak, the drug regulatory authorities earnestly implemented the decisions and deployments of the Party Central Committee and the State Council, performed their duties and fulfilled their duties, quickly activated the emergency approval mechanism for medical devices, and went all out to carry out emergency approval and post-marketing supervision of equipment for epidemic prevention and control.
Medical equipment has played a very important role in the overall battle against the epidemic.

 

　　We adhere to the principles of unified command, early intervention, follow-up review, and scientific approval, innovate working methods, communicate with science, technology, health and other departments in a timely manner, and incorporate major scientific research results into emergency approval in a timely manner.
We concentrate the high-quality resources and strength of the whole system, work day and night, carry out registration inspection, system verification, technical review in parallel, actively connect with enterprises, actively provide front-line services, strengthen the whole process of guidance, maximize the effect of review and approval, and speed up products Listed.

 

　　We adhere to departmental coordination, system linkage, multiple measures to build joint efforts, coordinate with market supervision, industry and information departments and other departments, implement "one enterprise, one policy" for conversion and expansion enterprises, and provide assistance and guidance.
A joint inspection team has been organized many times to go deep into the company's factory supervision and strengthen inspections.
Strengthen product sampling and risk monitoring, and urge enterprises to implement their main responsibilities to ensure product quality and safety.
At the same time, in accordance with the requirements of the joint prevention and control mechanism, cooperate with relevant departments to jointly ensure product supply and export guarantees.

 

　　In order to meet the needs of responding to major public health emergencies and expedite the use of emergency medical devices, the new "Regulations" system summarizes the experience of epidemic prevention and control, and adds and improves the following systems: First, the priority review and approval system, and innovation Medical devices are subject to priority review and approval.
The second is the conditional approval system.
Medical devices urgently needed in response to public health events may be approved with conditions on the basis of a comprehensive balance of benefits and risks.
The third is the emergency use system.
In the event of a particularly major public health emergency or other emergency that seriously threatens public health, medical devices can be used urgently within a certain range and time limit.

 

　　In addition, the new "Regulations" also added a special approval import system for clinical urgent needs.

 

　　In the next step, the State Drug Administration will further improve related systems in conjunction with the formulation and revision of supporting regulations and normative documents.
Recently, we have started the revision of the "Medical Device Registration Management Measures" and revised and improved the "Medical Device Emergency Approval Procedure".
Thank you.

 

　　 "

 

　　The newly revised "Regulations" fully implements the registrant system.
The Food and Drug Administration has already deployed some pilot projects.
How effective are these pilot projects? What is the significance of this system for strengthening the supervision of medical devices and implementing the main responsibility of enterprises? Thank you.

 

　　Xu Jinghe:

 

　　The medical device registrant system is a modern medical device management system commonly adopted by the international community, and it is also one of the core systems for the revision of the Regulations on the Supervision and Administration of Medical Devices.
The core of the system is that the medical device registrant is the "producer" of the medical device product, and is responsible for the safety and effectiveness of the medical device in the entire process of development, production, operation, and use.

 

　　In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" by the Office of the State Council of the Central Committee of the People’s Republic of China, the State Food and Drug Administration has launched a pilot program for the medical device registrant system since 2018.
Autonomous regions and municipalities directly under the Central Government.
The pilot work is mainly carried out around the following aspects: First, whether scientific research institutions can become medical device registrants.
The second is how to divide the rights and obligations between the registrant and the trustee when the registrant entrusts production.
The third is how to allocate the powers and responsibilities of the supervisory department when entrusting production in different places.
The fourth is how to effectively implement the registrant’s life cycle responsibilities.

 

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　　The fifth is to implement the requirement that people be punished for violations.
Increasing the system of penalties for violations of the law is an innovation in legislation in the field of food and drug supervision in recent years.
There are more than 10 provisions in the new "Regulations" that stipulate that people should be punished for violations.
In addition to penalizing illegal units, the legal representatives, main responsible persons, directly responsible persons in charge and other responsible persons of the illegal units have stipulated property penalties, qualification penalties, and confiscation of the income received from the unit during the period of the illegal act, and A fine of up to three times the income received by the premises is forbidden to engage in the production and operation of medical devices for five years to life.
In addition, the new "Regulations" also added systems for the traceability of medical device unique identification, online sales management, and punishment for dishonesty, and revised and improved relevant regulations on the commissioned production of medical devices and the re-evaluation after the market.

 

　　In the next step, we will implement the new "Regulations", formulate and revise relevant departmental regulations, further implement detailed relevant systems and measures, strengthen supervision, improve efficiency, ensure the quality and safety of medical devices, and promote the high-quality development of the medical device industry.
Thank you.

 

　　 "

 

　　We all know that the supervision and governance of medical devices involves many aspects.
How do we grasp and handle the relationship between safety and development, risk and responsibility in the implementation of the "Regulations"?

 

　　Xu Jinghe:

 

　　Thank you reporter for your question.
Law is the institutional arrangement of public happiness.
Medical device supervision and management involves many relationships such as safety and development, risk and responsibility, system and capability, quality and efficiency.
Scientifically grasping and correctly handling these relationships is not only a kind of wisdom, but also an art.
Here is a brief talk about the relationship between several aspects:

 

　　First, we must scientifically grasp the relationship between security and development.
Security is the foundation of development, and development is the guarantee of security.
The new "Regulations" fully embodies the dialectical relationship between safety and development.
In terms of safety, the new "Regulations" adopt a series of systems and measures to strengthen the quality and safety of medical devices.
For example, medical device registrants and filing personnel are responsible for the quality and safety of the entire life cycle.
In terms of development, the new "Regulations" clearly propose that the country should improve the medical device innovation system, put medical device innovation into the focus of development, give priority to the review and approval of innovative medical devices, support the clinical promotion and application of innovative medical devices, and promote the high level of the medical device industry.
Quality development.

 

　　Second, we must scientifically grasp the relationship between risk and responsibility.
Risk management is the cornerstone of medical device management.
The new "Regulations" for the first time legislates risk management as the basic principle of medical device supervision.
On the basis of classified management, it further clarifies that clinical evaluation or clinical evaluation of medical devices can be carried out based on factors such as risks.
For the test, Director Deyuan has just introduced the relevant situation.
At the same time, registrants are required to improve the quality management system, formulate risk management and control plans and ensure effective implementation.
Responsibility governance is the essence of medical device governance.
Only when responsibilities are fully implemented can risks be fully prevented and controlled.
The new "Regulations" improve the three major responsibility systems.
In terms of the responsibility of business owners, a system of medical device registrants and recorders has been established; in terms of government supervision, the leadership and management responsibilities of local people's governments in medical devices have been clarified for the first time; In terms of social co-governance, the requirements of relevant departments and social organizations to support the innovative development of medical devices have been clarified.

 

　　Third, we must scientifically grasp the relationship between system and capability.
Modern medical device management is scientific management based on systems and capabilities.
Only a complete governance system can have excellent governance capabilities.
In terms of system construction, the new "Regulations" strengthened the construction of the medical device supervision system and strengthened the construction of the enterprise quality management system.
In terms of capacity building, the new "Regulations" emphasize that the country should improve the medical device innovation system and improve its independent innovation capabilities.
Local people's governments at or above the county level shall strengthen the capacity building of medical device supervision and management.
The registrant must have quality assurance capabilities.
Clinical trial institutions should strengthen the construction of clinical trial capabilities.

 

　　Fourth, we must scientifically grasp the relationship between quality and efficiency.
Quality and efficiency are the eternal theme of medical devices.
The new "Regulations" always adhere to the bottom line of medical device quality and safety, and ensure that this bottom line can be firmly grasped by fully implementing the "four most stringent" requirements.
At the same time, the new "Regulations" adopted a series of measures such as innovating the regulatory system, improving the regulatory system, optimizing the regulatory process, and enhancing the regulatory capabilities, such as implied licensing of clinical trials, shortening the review period of production and operation licenses, etc.
, to speed up medical care.
The speed of equipment products to market can better meet the public's demand for equipment.
It is also particularly emphasized here that while fully implementing the requirements of “decentralization, regulation and service” and accelerating the pace of product launches, it is necessary to ensure product quality and safety, that is, to organically unify quality and efficiency.

 

　　Fifth, we must scientifically grasp the relationship between unit responsibility and individual responsibility.
The content of legal relations is rights and obligations, and can also be summarized as responsibilities.
While the new "Regulations" comprehensively strengthen unit responsibilities, it also strengthens the penalties for natural persons for illegal acts, including property penalties, qualification penalties, and personal freedom penalties.
Both Director Zhenjiang and Director Zhexiong gave a good introduction just now.
It should be said that the perpetrators behind unit crimes or unit crimes are often natural persons.
While punishing units that violate the law, the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit should be increased in accordance with the law.
Legal sanctions, this "double-penalty system" is an important innovation in the construction of administrative rule of law, and it also captures the key points of penalties for illegal and criminal acts.
This system is conducive to further enhancing the deterrence of the law.
Therefore, everyone is very concerned about the "Medical Device Supervision and Administration Regulations" in implementing the "four most stringent" aspects, especially the many innovations in increasing penalties for illegal acts.
I believe this system will be able to effectively exert its deterrent effect.
Thank you.